RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Conditional marketing approval (China), Breakthrough Therapy (China), Priority Review (China)

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Sequence Code 756146862L

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Sequence Code 756146864H

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Clinical Trials associated with Becotatug vedotin

NCT07303283

/ Not yet recruitingPhase 2IIT

Single-agent Becotatug Vedotin as Adjuvant Therapy for High-risk Locoregional Advanced Nasopharyngeal Carcinoma: a Multicentre, Open-label, Parallel-group, Randomised, Controlled, Phase 2 Trial

This is a phase 2, multicentre, open-label, randomised, controlled trial with a parallel-group design. The study aims to evaluate the efficacy and safety of single-agent Becotatug Vedotin as adjuvant therapy in patients with high-risk locoregionally advanced nasopharyngeal carcinoma (NPC).

Start Date01 Sep 2026

Sponsor / Collaborator

Guangxi Medical University

[+6]

NCT07518979

/ Not yet recruitingPhase 2IIT

Neoadjuvant Therapy With EGFR-ADC (Becotatug Vedotin) Combined With PD-1 Inhibitor (Pucotenlimab) for Penile Squamous Cell Carcinoma With Penile Preservation Difficulty or Regional Lymph Node Metastasis: A Single-Arm, Phase II Clinical Trial

This clinical study is a Phase II research trial focused on a new preoperative treatment for men with advanced penile squamous cell carcinoma (a type of penile cancer). The cancer may be hard to treat with penile-sparing surgery, or it may have spread to nearby lymph nodes (like groin lymph nodes).
We are testing a combination of two medicines: Becotatug vedotin (a targeted therapy that finds and kills cancer cells with high levels of a protein called EGFR) and Pucotenlimab (an immunotherapy that helps your body's immune system fight cancer). The goal is to see if this combination can shrink the tumor, make surgery more likely to remove all cancer cells, and improve treatment outcomes-while keeping side effects manageable.
Who can join?
To be eligible, you must:
Be a man 18 years or older with confirmed penile squamous cell carcinoma; Have cancer that is hard to treat with penile-sparing surgery or has spread to regional lymph nodes; Have cancer cells that test positive for EGFR (a protein most penile cancers make); Have not received prior systemic cancer treatment (or had recurrence more than 6 months after adjuvant therapy for radical resection); Have adequate organ function (e.g., healthy heart, liver, and kidney function) to tolerate treatment; Understand the study and voluntarily agree to participate by signing an informed consent form.
What will happen during the study? Screening (up to 28 days): You will have tests to confirm eligibility, including imaging scans, blood work, and EGFR testing on your tumor sample.
Preoperative treatment (4-6 cycles): You will receive intravenous infusions of Becotatug vedotin (2.0 mg/kg) and Pucotenlimab (200 mg) every 3 weeks. Every 6 weeks, you will have imaging scans to check if the tumor is shrinking.
Surgery: If the tumor responds to treatment (assessed by a team of doctors), you will undergo radical surgery to remove the cancer. If surgery is successful, you may continue Pucotenlimab as adjuvant therapy for 1 year.
Follow-up: After treatment, you will be checked every 3 months for 2 years to monitor for cancer recurrence and long-term side effects.
What are the study goals? Primary goal: To find out how many patients can have successful surgery to remove all visible cancer (R0 resection) after the combination treatment.
Secondary goals: To measure how much the tumor shrinks (objective response rate), if the cancer stage improves (downstaging rate), if surgery removes all cancer cells (pathological complete response rate), how long patients stay cancer-free (disease-free survival), and how safe the treatment is.
What are the potential risks? As with any cancer treatment, this combination may cause side effects. Common expected side effects include skin reactions (e.g., rash), digestive issues, changes in blood cell counts, liver function changes, and immune-related reactions (e.g., thyroid problems, lung inflammation). These side effects will be closely monitored by the study team, and treatments to manage them will be provided.
This study is being conducted at West China Hospital, Sichuan University. It is a single-arm trial (all participants receive the same combination treatment) and will enroll about 60 patients. The study is expected to run from April 2026 to April 2028.

Start Date30 Jul 2026

Sponsor / Collaborator

West China Hospital

[+1]

NCT07627321

/ Not yet recruitingPhase 2IIT

PRAD2: A Prospective, Single-Arm, Multi-Center, Exploratory Study of Becotatug Vedotin Combined With Pucotenlimab ± Radiotherapy as First-Line Treatment for Driver-Gene-Negative, EGFR-Expression-Positive Advanced Non-Small Cell Lung Cancer

This prospective, single-arm, exploratory multicenter clinical study aims to investigate the safety and efficacy of Becotatug vedotin combined with Pucotenlimab (with or without radiotherapy), followed by Pucotenlimab maintenance therapy, in patients with driver gene-negative (e.g., EGFR, ALK, ROS1), EGFR-overexpressing non-small cell lung cancer (NSCLC).
Study Population:
The study targets patients with driver gene-negative (EGFR, ALK, ROS1, and other actionable targets) non-squamous and squamous NSCLC. All subjects (regardless of smoking history) must provide testing reports for EGFR, ALK, and ROS1. If no prior report exists, baseline biopsy or submission of archived tissue for assessment of driver gene status (via local or central laboratory) is mandatory. Additionally, eligible patients must have an immunohistochemistry (IHC)-confirmed EGFR expression level of 2+ or higher, be previously untreated with systemic therapy for stage IV NSCLC, have measurable lesions, show no active central nervous system metastases or uncontrolled autoimmune diseases, and voluntarily sign the informed consent form.
Treatment Regimen:
Subjects meeting the inclusion/exclusion criteria will receive the following treatment regimen:
Pucotenlimab (HX008): Administered from Cycle 1 to Cycle 4 at a dose of 3 mg/kg (maximum 200 mg), once every 3 weeks on Day 1 (D1). Intravenous infusion (60 ± 15 minutes; first cycle infusion duration not less than 60 minutes).
Becotatug vedotin (MRG003): Administered from Cycle 1 to Cycle 4 at a dose of 2.0 mg/kg, once every 3 weeks on D1. Administration begins at least 30 minutes after the completion of Pucotenlimab infusion. Intravenous infusion (60 ± 10 minutes; first cycle infusion duration not less than 60 minutes).
Radiotherapy: Investigators may opt to include sequential radiotherapy based on tumor size, number, location, extent of invasion, and individual patient factors. Radiotherapy options are as follows:
Target Volume: Radiotherapy commences 2 weeks (±7 days) after the completion of Cycle 4 treatment, targeting only the primary tumor or specific 1-2 metastatic lesions.
Fractionation and Dosage:
Conventional Fractionation Group: Applicable for larger target volumes (>5 cm diameter) or involvement of mediastinal lymph nodes. Total dose: 45-60 Gy; single fraction dose: 1.8-2.0 Gy; administered once daily (Qd).
Stereotactic Body Radiotherapy (SBRT) Group: Applicable for oligometastatic lesions (≤3 lesions, each ≤3 cm diameter). Total dose: 30-50 Gy delivered in 3-5 fractions; single fraction dose: 6-10 Gy.
Maintenance Therapy: Pucotenlimab (HX008) monotherapy until disease progression (defined by RECIST 1.1), investigator-assessed radiographic progression, unacceptable toxicity, withdrawal of consent, or fulfillment of criteria for discontinuation of intervention.

Start Date15 Jul 2026

Sponsor / Collaborator

Anhui Provincial Cancer Hospital

100 Clinical Results associated with Becotatug vedotin

100 Translational Medicine associated with Becotatug vedotin

100 Patents (Medical) associated with Becotatug vedotin

472

Literatures (Medical) associated with Becotatug vedotin

01 Jun 2026·ANNALS OF ONCOLOGY

Becotatug Vedotin for Recurrent/Metastatic Nasopharyngeal Carcinoma (Magic-M001): A Multicenter, Randomized Trial

Article

Author: Pan, S M ; Xu, M J ; Li, Q ; Qu, S ; Zhou, Y J ; Yang, K Y ; Wang, F ; Xiang, Y Q ; Dou, Y W ; Wang, X H ; Dai, R ; Wei, Y ; Guo, Y ; Du, Y Q ; Huang, S T ; Xu, R H ; Li, J G ; Zhang, P ; Jin, Y S ; Lin, H M ; Wu, W L ; Shu, X L ; Xiao, S W ; Chen, X Z ; Qiu, S F ; Xu, G Q ; Wu, H ; Tang, L Q ; Huang, Y J ; Han, F

BACKGROUND:

Patients with recurrent/metastatic nasopharyngeal carcinoma (NPC) had limited treatment option and dismal prognosis after failure to programmed cell death protein 1/programmed death ligand 1 (PD-1/PD-L1) inhibitors and chemotherapy.

METHODS:

This multicenter, open-label, randomized trial investigated anti-epidermal growth factor receptor antibody-drug conjugate becotatug vedotin in patients with recurrent/metastatic NPC after failure to ≥2 lines of systemic therapies, including chemotherapy and PD-1/PD-L1 inhibitors. Eligible participants were randomized 1:1 to receive becotatug vedotin 2.3 mg/kg every 3 weeks or chemotherapy (capecitabine or docetaxel). The co-primary endpoints were the independent review committee-confirmed objective response rate (ORR), progression-free survival (PFS), and overall survival (OS).

RESULTS:

Between April 6, 2023, and December 27, 2023, a total of 173 patients were randomized, with 86 assigned to becotatug vedotin and 87 to chemotherapy. As of June 30, 2024, the ORR was significantly higher with becotatug vedotin than with chemotherapy (30.2% vs 11.5%; P = 0.003). With a median follow-up of 7.39 months, becotatug vedotin was associated with a significantly reduced risk of disease progression or death compared with chemotherapy (median PFS, 5.82 vs 2.83 months; hazard ratio, 0.63; 95% CI, 0.43-0.91; log-rank P = 0.01). As of December 30, 2024, the interim OS analysis showed a median OS of 17.08 months with becotatug vedotin and 11.99 months with chemotherapy (hazard ratio, 0.73; 95% CI, 0.48-1.12; log-rank P = 0.15), with a median follow-up of 13.47 months. The safety profiles were comparable between treatment groups.

CONCLUSIONS:

Among patients with heavily pretreated and immunotherapy-exposed recurrent or metastatic NPC, becotatug vedotin significantly improved ORR and PFS compared with chemotherapy, with comparable toxicity and encouraging but immature OS results.

01 May 2026·CURRENT OPINION IN ONCOLOGY

Recent highlights and breakthroughs in immunotherapy for head and neck cancers

Review

Author: Vuille, Joanna A ; Szturz, Petr

Purpose of review:

This review highlights recent advances in immunotherapy for head and neck oncology, focusing on pivotal studies, both early-stage and late-stage, published or presented in 2025.

Recent findings:

Noteworthy results were reported with immune checkpoint inhibitors in mucosal squamous cell carcinoma of the head and neck (SCCHN) (KEYNOTE-689 and NIVOPOSTOP trials evaluating pembrolizumab and nivolumab, respectively, in the perioperative setting); in nasopharyngeal carcinoma (DIPPER and DIAMOND trials evaluating camrelizumab and toripalimab, respectively, in the curative setting with radiotherapy, and tagitanlimab in recurrent and/or metastatic disease); in cutaneous squamous cell carcinoma of the head and neck region (C-POST trial in the adjuvant setting and the combination of avelumab with cetuximab in the palliative setting); and in BRAF V600E-mutated anaplastic thyroid carcinoma (pembrolizumab with dabrafenib and trametinib). Passive immunotherapy targeting tumor-associated antigens also showed encouraging activity in R/M-SCCHN (petosemtamab, ficerafusp-alfa, amivantamab, enfortumab vedotin) and in heavily pretreated R/M nasopharyngeal carcinoma (antibody-drug conjugates becotatug vedotin and izalontamab brengitecan [iza-bren]).

Summary:

Recent advances highlight a rapid surge in positive immunotherapy trials across different head and neck cancer entities, with clinical benefit observed both when immune checkpoint inhibitors are moved earlier in the disease course and when they are combined with agents targeting resistance mechanisms or enabling more precise drug delivery to tumors.

15 Apr 2026·CLINICAL CANCER RESEARCH

Becotatug Vedotin in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: A Multicenter, Phase IIa Trial

Article

Author: Wang, Siyang ; Zhang, Songnan ; Fang, Meiyu ; Han, Yaqian ; Zhang, Qingyuan ; Xue, Liqiong ; Liu, Yanyan ; Guo, Ye ; Li, Xia ; Li, Zhiming ; Zhong, Laiping

Abstract:

Purpose::

This multicenter, phase IIa trial (NCT04868162) investigated the efficacy and safety of becotatug vedotin, an anti–epidermal growth factor receptor (EGFR) antibody–drug conjugate, in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) who have limited therapeutic options.

Patients and Methods::

Patients with R/M SCCHN who progressed after platinum-based chemotherapy and/or programmed cell death 1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitors, including those with multiple lines of prior therapy, were administered intravenous becotatug vedotin at either 2 or 2.3 mg/kg every 3 weeks. The primary endpoint was the objective response rate (ORR).

Results::

Sixty-seven patients were enrolled (35 received 2 mg/kg and 32 received 2.3 mg/kg). The ORR was 20.9% [14/67, 95% confidence interval (CI), 11.9–32.6], with a median duration of response (DoR) of 10.9 months (95% CI, 2.6–15.1). The median progression-free survival (PFS) was 2.9 months (95% CI, 1.8–3.9), and the median overall survival (OS) was 6.7 months (95% CI, 5–8.9). Treatment-related adverse events (TRAE) were reported in 91% (61/67) patients, most commonly being rash (26.9%), pruritus (25.4%), constipation (23.9%), and anemia (20.9%).

Conclusions::

Becotatug vedotin demonstrated promising antitumor activity with a manageable safety profile in previously heavily treated R/M SCCHN, particularly at the recommended dose of 2.3 mg/kg, among patients who had failed platinum-based chemotherapy and PD-1/PD-L1 inhibitors (≤2 prior lines of therapy).

News (Medical) associated with Becotatug vedotin

05 Mar 2026

·allsci.com

Hutchmed advances ATTC platform with first-in-human trial of EGFR-targeted PI3K/PIKK conjugate

China-based biopharma HutchMed (Nasdaq/AIM:HCM;HKEX:13) announced the clinical debut of pipeline candidate HMPL-A580, an antibody-targeted therapy conjugate (ATTC) designed to deliver a PI3K/PIKK inhibitor payload via an anti-EGFR antibody. The molecule has entered a Phase I/IIa first-in-human clinical trial in patients with unresectable, advanced, or metastatic solid tumors, with a first patient dosed. The multicenter, open-label study is being held across sites in China and the United States.; AllSci trial listing HMPL-A580 is the second clinical candidate from Hutchmed’s next-generation ATTC platform, which conjugates proprietary small-molecule inhibitor payloads to monoclonal antibodies using cleavable linkers. The first is HMPL-A251, a which also uses a PI3K/PIKK inhibitor payload but conjugated to a humanized anti-HER2 IgG1 antibody and entered the clinic in December 2025. The two-part trial for HMPL-A580 includes a dose-escalation phase to establish maximum tolerated and recommended expansion dosages, followed by Phase IIa expansion to characterize safety, tolerability, and preliminary anti-tumor activity. The trial (NCT07396584) will enrol 186 patients with primary completion forecast by December 2028. No approved therapy currently combines EGFR targeting with intracellular PI3K pathway inhibition within a single conjugate molecule. Most programs aimed at the PI3K/AKT/mTOR (PAM) pathway rely instead on systemic small-molecule inhibitors engineered for mutant selectivity or isoform specificity to improve tolerability. Relay Therapeutics is advancing RLY-2608, a mutant-selective PI3Kα inhibitor, in a Phase II pivotal study in PIK3CA-mutated breast cancer. Eli Lilly is developing STX-478, a mutant-selective PI3Kα inhibitor acquired through its purchase of Scorpion Therapeutics, in early clinical studies. Taiho Oncology is evaluating TOS-358, a covalent PI3Kα inhibitor, in Phase I/Ib trials. Celcuity and Pfizer are also advancing gedatolisib, a dual pan-PI3K/mTOR inhibitor, which has reached late-stage development in breast cancer. These programs deliver pathway inhibition through systemic oral or intravenous small molecules. HMPL-A580 represents a divergent strategy: using antibody-directed delivery to restrict pathway inhibition to EGFR-expressing tumor cells, potentially widening the therapeutic index relative to conventional systemic PI3K inhibitors. The antibody-drug conjugate field has also explored EGFR-targeted delivery, though typically using cytotoxic payloads rather than targeted pathway inhibitors. For example, MRG003, an EGFR-directed ADC developed by Lepu Biopharma, carries a monomethyl auristatin payload and is being evaluated in clinical studies in solid tumors. In contrast, Hutchmed’s ATTC platform attaches a targeted therapy payload — in this case a PI3K/PIKK inhibitor — rather than a conventional cytotoxic warhead. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Phase 2ADCINDPhase 1

05 Nov 2025

·www.prnewswire.com

BioDlink Congratulates Lepu Biopharma on Securing Approval for the World's First Approved EGFR-Targeted ADC

BioDlink helps Lepu Biopharma win China's marketing approval for EGFR-targeted ADC treating recurrent or metastatic nasopharyngeal carcinoma This Becotatug Vedotin injection approval is BioDlink's first commercial ADC manufacturing initiative worldwide, validating its complex biologics commercialization capabilities SUZHOU, China, Nov. 5, 2025 /PRNewswire/ -- BioDlink (1875.HK) congratulates its partner Lepu Biopharma (2157.HK) on receiving conditional marketing approval from China's National Medical Products Administration (NMPA) for MEIYOUHENG (Becotatug Vedotin injection). This Class 1 innovative antibody-drug conjugate (ADC) targets the epidermal growth factor receptor (EGFR) for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC). Significantly, this is the world's first approved non-photoimmunological EGFR-targeted ADC and a first-in-class innovation. This project is BioDlink's first commercial ADC manufacturing initiative globally, validating its robust capabilities in the commercialization of complex biologics. This approval builds on BioDlink's earlier success with Lepu Biopharma's ADC program that achieved 100% first-pass success across technology transfer, Process Performance Qualification (PPQ), and Pre-Approval Inspection (PAI). The program, designated as a Breakthrough Therapy Project, required rapid tech transfer and full production line delivery from monoclonal-antibody Drug Substance through ADC Drug Product. BioDlink's performance in this project secured BLA approval on October 30, 2025, demonstrating its capacity to meet aggressive regulatory timelines and ensure commercial readiness for global markets. ADC manufacturing is technologically demanding, requiring exceptional process capabilities and robust quality systems. BioDlink participated in the entire development and production cycle, from technology transfer, process development, and analytical method establishment to clinical sample and GMP-compliant commercial batch manufacturing. This reflects the company's end-to-end capabilities in supporting complex biologics from R&D to market launch. Through close coordination with Lepu Biopharma and multiple regulatory authorities, BioDlink established an integrated quality management system. This system ensures seamless coordination across the entire production chain—accelerate the timeline for pivotal clinical batch production and subsequent PPQto meet aggressive regulatory submission goals and aligns with global GMP standards, including those of China, the U.S., and the EU. BioDlink's manufacturing facilities have obtained GMP certifications from several countries and Foreign Manufacturer Approval from Japan's PMDA. This collaboration sets a practical model for efficient multi-party industry collaboration and resource integration in the biopharma sector. BioDlink's manufacturing facilities have obtained GMP certifications from China, Brazil, Argentina, Indonesia, Egypt, Colombia, Pakistan and Thailand, as well as Foreign Manufacturer Approval from Japan's PMDA. And also passed EU-QP 5 times in these years. This achievement marks a major step forward for ADC commercialization and demonstrates a practical model for multi-party industry collaboration and efficient resource integration. Dr. Ziye Sui, Executive Director and CEO of Lepu BioPharma, commented: "We sincerely thank the BioDlink team for their outstanding CDMO services and strong collaboration. This approval also establishes a practical pathway for multi-party collaboration, offering new hope for R/M NPC patients who have failed anti-PD-(L)1 and platinum-based therapies." Dr. Jian Zhang, Chief Operating Officer, BioDlink, noted: "The approval of this pilot batch highlights the increasing technical and quality coordination demands placed on both the Marketing Authorization Holder (MAH) and the CDMO. Moving forward, we will continue working closely with our partners to accelerate the launch of innovative medicines to benefit patients worldwide." About Becotatug Vedotin MEIYOUHENG (Becotatug Vedotin injection) is an ADC comprised of an EGFR-targeted monoclonal antibody conjugated with the potent microtubulin inhibiting payload monomethyl auristatin E via a valine-citrulline linker. It is the world's first approved EGFR-targeted ADC and a first-in-class innovation, for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC). It binds specifically with high affinity to EGFR on the surface of tumor cells, releases the potent payload upon internalization and lysosomal protease cleavage of the linker and results in tumor cell death. EGFR is highly expressed in colorectal cancer, lung cancer, head and neck cancer and other malignant solid tumors, and is expressed in 89% advanced NPC. Therefore, EGFR is an important target for cancer treatment. About Lepu Biopharma Lepu Biopharma Co., Ltd. (Stock Code: 02157.HK) is an innovation-driven company focusing on oncology therapeutics, in particular, targeted therapy and oncology immunotherapy, with a strong China foundation and global vision. The company is dedicated to developing innovative ADCs through its advanced ADC technology platform. Lepu Biopharma highly values the continuing build-out of its own commercialization capabilities and is determined to pursue the goal towards strong transformation from core technology to drugs and industrialization. At present, the product pipeline of Lepu Biopharma covers three major areas, namely immunotherapies, ADC targeted therapies and oncolytic virus drugs, including two commercialization- stage drug candidates, eigth clinical-stage drug candidates (six of which are ADC drug candidates) and three clinical-stage combination therapies of the key candidates in its pipeline. The company houses the leading ADC drug candidate pipeline in China. About BioDlink Biopharm Co., Ltd. BioDlink (1875.HK) is a leading global CDMO specializing in biologics and bioconjugates (ADCs/XDCs). Headquartered in Suzhou with centers in Shanghai and Beijing, the company provides fully integrated, end-to-end services spanning early R&D through commercial manufacturing. With its one-base integrated platform and proprietary technologies—such as BDKcell® for rapid cell line development and GL-DisacLink® for site-specific conjugation—BioDlink helps partners accelerate development, improve efficiency, and reduce costs. The company operates four commercial manufacturing lines with large-scale sterile fill-finish capabilities, backed by a global GMP-aligned quality system that has earned PMDA accreditation in Japan and supported product approvals across China, Indonesia, Nigeria, Pakistan, and Colombia. Guided by the philosophy of "Quality First, Innovation Driven, Success Together," BioDlink is committed to advancing global access to next-generation biologics and building trusted partnerships worldwide. For more information, please visit: SOURCE BioDlink Biopharm Co., Ltd. 21% more press release views with Request a Demo

Drug ApprovalBreakthrough TherapyADCImmunotherapy

20 Aug 2025

·pipelinereview.com

ALX Oncology Doses First Patient in Phase 1 Dose Escalation Trial Evaluating ADC ALX2004 for the Treatment of EGFR-Expressing Solid Tumors

– A potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of EGFR-expressing solid tumors, ALX2004 is uniquely designed with every component optimized to maximize the therapeutic window -First-in-human trial of ALX2004 builds upon body of positive preclinical data demonstrating dose dependent anti-tumor activity and favorable safety profile -Initial safety data anticipated in first half 2026 SOUTH SAN FRANCISCO, CA, USA I August 19, 2025 I ALX Oncology Holdings Inc., (“ALX Oncology” or the”Company”) (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today announced that the first patient has been dosed in the Company’s Phase 1 clinical trial for ALX2004, a potential best- and first-in-class, epidermal growth factor receptor (EGFR) ADC that is being studied for the treatment of EGFR-expressing solid tumors. “Dosing of the first patient in the Phase 1 trial is an important milestone in ALX Oncology’s mission to develop a pipeline of best-in-class drugs; ALX2004 is our first ADC and treating our first patient with this drug is a significant step forward in fulfilling the potential of EGFR-targeted ADCs,” said Jason Lettmann, Chief Executive Officer at ALX Oncology. “Our preclinical data supports our conviction that ALX2004, with its optimized antibody, linker and payload, has the potential to overcome the toxicity challenges that have limited earlier generation EGFR-targeted ADCs. We look forward to enrolling this trial and expect to report initial safety data in the first half of 2026.” The Phase 1 clinical trial ( NCT07085091 ) is a first-in-human, open-label multicenter study evaluating ALX2004 in participants with advanced or metastatic select EGFR-expressing solid tumors. The study consists of a Phase 1a dose escalation portion followed by dose exploration, and a Phase 1b dose expansion. The dose escalation portion of the trial will enroll patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC) and colorectal cancer (CRC). All or a subset of these tumor types may be included in the dose exploration and expansion portions of the trial. ALX2004: Optimized for Success Based on Rigorous Drug Design Process Developed by ALX Oncology’s protein engineers utilizing the Company’s proprietary topoisomerase I inhibitor (Top1i) payload and linker payload platform, ALX2004 is a uniquely designed EGFR-targeted ADC where every component is optimized to maximize the therapeutic window by reducing toxicity. This includes an affinity-tuned EGFR antibody with a binding epitope distinct from approved EGFR antibodies. ALX2004 also has a proprietary Top1i payload engineered to offer enhanced bystander effect with improved linker stability for on-target delivery of payload. Robust Preclinical Data: Supporting Differentiation in EGFR-ADC Class Preclinical data supports ALX2004’s differentiated linker-payload construct, which has demonstrated superior stability versus other ADCs in its class, with dose-dependent activity and a favorable safety profile. In addition, ALX2004 has shown dose-dependent activity across a range of tumors, EGFR expression levels and mutations. Potent activity in tumor models supports its potential for treating patients with EGFR-expressing tumors. Preclinical model findings did not demonstrate EGFR-related skin toxicity at clinically relevant doses or payload-related interstitial lung disease, supportive of a potentially differentiated safety profile. About ALX Oncology ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action and entered the clinic in a Phase 1 trial in August 2025. More information is available at www.alxoncology.com and on LinkedIn @ ALX Oncology . SOURCE: ALX Oncology

Phase 1ADCImmunotherapy

100 Deals associated with Becotatug vedotin

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Nasopharyngeal Carcinoma	China	Lepu Biopharma Co., Ltd.	28 Oct 2025

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Squamous cell carcinoma of head and neck metastatic	Phase 3	China	Shanghai Miracogen, Inc.	01 Mar 2023
Squamous Cell Carcinoma of the Penis	Phase 2	China	Lepu Medical Technology (Beijing) Co., Ltd.	30 Jul 2026
Cutaneous Squamous Cell Carcinoma	Phase 2	China	Lepu Biopharma Co., Ltd.	09 Jan 2026
Locally Advanced Head and Neck Squamous Cell Carcinoma	Phase 2	France	Lepu Medical Technology (Beijing) Co., Ltd.	13 Oct 2025
Nasopharyngeal Cancer, Recurrent	Phase 2	China	Shanghai Miracogen, Inc.	06 Apr 2023
Advanced Malignant Solid Neoplasm	Phase 2	China	Shanghai Miracogen, Inc.	30 Jun 2022
EGFR mutation Solid Tumors	Phase 2	China	Shanghai Miracogen, Inc.	30 Jun 2022
stomach adenocarcinoma	Phase 2	China	Shanghai Miracogen, Inc.	18 Oct 2021
Advanced gastric carcinoma	Phase 2	China	Shanghai Miracogen, Inc.	24 May 2021
Metastatic Gastric Carcinoma	Phase 2	China	Shanghai Miracogen, Inc.	24 May 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT07381075 (ASCO2026)	Phase 2	Locally Advanced Head and Neck Squamous Cell Carcinoma Neoadjuvant	60	Becotatug Vedotin + Ivonescimab	zhjltgacdq(irrawboqeh) = ddvldonsrt cqcaaybcdk (gejcndihnr )	Positive	29 May 2026
NCT04868162 (Pubmed \| Literature)	Phase 2	Squamous Cell Carcinoma of Head and Neck	67	Becotatug Vedotin	lxsjnlkioc(neqfolyrxb) = dybyewvepp amdtuciaab (lvsqykxcgx, 11.9 - 32.6) View more	Positive	15 Apr 2026
NCT05688605 (HX008/MRG003-C001, ESMO2025) Manual	Phase 2	Nasopharyngeal Cancer, Recurrent Second line	30	becotatug vedotin (HX008)pucotenlimab (MRG003)	sdqgnepqyg(wsychcjqfe) = zpppijufjx fazsmzmteb (rguzrzonlw ) View more	Positive	17 Oct 2025
NCT05688605 (HX008/MRG003-C001, ESMO2025) Manual	Phase 2	Squamous cell carcinoma of head and neck metastatic \| Recurrent Squamous Cell Carcinoma of the Head and Neck First line	37	Becotatug vedotin 2.0 mg/kg + pucotenlimab	cmxflxhnor(axxiruizwj) = ssgsfojgus avvaorktzw (msypjnipkc ) View more	Positive	17 Oct 2025
				Becotatug vedotin 2.3 mg/kg + pucotenlimab	cmxflxhnor(axxiruizwj) = ycpjsecaob avvaorktzw (msypjnipkc ) View more
NCT05126719 (ASCO2025) Manual	Phase 2	Advanced Nasopharyngeal Carcinoma Third line	173	MRG003	zhxzqqjgqa(cgmafhuclo) = qkzmhjadsw tprzgshzuq (isbsqebaah, 11.4 - NE) View more	Positive	30 May 2025
				Chemotherapy	zhxzqqjgqa(cgmafhuclo) = yeoghcelul tprzgshzuq (isbsqebaah, 9.7 - 15.4) View more
NCT05688605 (HX008/MRG003-C001, ESMO_ASIA2024) Manual	Phase 2	Nasopharyngeal Carcinoma	30	Pucotenlimab (HX008) 3.0 mg/kg + EGFR-ADC (MRG003) 2.0 mg/kg	fjqnanppqt(qlfithgzoz) = twegkunfsd escbotaody (qkbqhhwtsv, 59.7 - 73.7) View more	Positive	07 Dec 2024
NCT05688605 (Phase I/II study, ASCO2024) Manual	Phase 1/2	EGFR mutation Solid Tumors EGFR-positive	33	Pucotenlimab(HX008) + MRG003	ujffwpyfcn(sehoxdkixu) = pdcgnwfbjn kqgqqsmbse (fotgpfrlzi ) View more	Positive	24 May 2024
NCT04868162 (ESMO 12023 \| ESMO 22023) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck EGFR expression	67	MRG003	tkvbyzvywv(wejdpwlaui) = vsjlcvnljg pxmphljngo (bacpqeiwvl )	Positive	22 Oct 2023
				MRG003 (2.3 mg/kg)	tkvbyzvywv(wejdpwlaui) = qdlieycges pxmphljngo (bacpqeiwvl ) View more
NCT05126719 (MRG003, ESMO2023 \| NEWS) Manual	Phase 2	Nasopharyngeal Carcinoma	61	MRG003 2.0 mg/kgMRG003 2.0 mg/kg	boepjpwywf(ecsqvblihd) = ctvqjoykij sgbfdutlex (blazjopuog ) View more	Positive	21 Oct 2023
				MRG003MRG003 2.3 mg/kg	boepjpwywf(ecsqvblihd) = wbvmuhwztv sgbfdutlex (blazjopuog ) View more
NCT05126719 (MRG003, CSCO2022)	Phase 2	Nasopharyngeal Carcinoma Last line	61	MRG003 2.0mg/kg	klitplsoon(oyfkhwtntj) = yzxbmtxtai gvlbroblgh (mpztyfxlpv ) View more	Positive	21 Sep 2022
				MRG003 2.3mg/kg	klitplsoon(oyfkhwtntj) = nmfftqrkzm gvlbroblgh (mpztyfxlpv ) View more

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