An Open-Label, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, PK/PD and Preliminary Efficacy of HBM4003 in Combination With Toripalimab/ Tislelizumab in Patients With Advanced NEN and Other Solid Tumors

To select RP2D/MTD of HBM4003 in combination with Toripalimab in dose confirmation part(Part 1) and use the RP2D in dose expansion part (Part 2) to evaluate the safety, tolerability, PK/PD and preliminary efficacy of in patients with advanced NEN and other solid tumors

Start Date28 Dec 2021

Sponsor / Collaborator

Hopp Pharmaceutical (Guangzhou) Co., Ltd.

NCT05149027

/ Not yet recruitingPhase 1

An Open-Label, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, PK/PD and Preliminary Efficacy of HBM4003 in Combination With Toripalimab in Patients With Advanced HCC and Other Solid Tumors

This is an open-label, multi-center phase 1 study. The trial, consisting of Part
1 dose confirmation and Part 2 dose expansion, is designed to evaluate the safety, tolerability, PK/PD and preliminary efficacy of HBM4003 in combination with Toripalimab in patients with advanced HCC and other solid tumors.

Start Date20 Dec 2021

Sponsor / Collaborator

Hopp Pharmaceutical (Guangzhou) Co., Ltd.

NCT04727164

/ Not yet recruitingPhase 1

An Open Phase I Study to Evaluate the Safety, Tolerability, PK / PD, and Initial Efficacy of HBM4003 in Combination With Toripalimab in Patients With Advanced Melanoma and Other Solid Tumors

HBM4003 in combination with Toripalimab. The expected duration of treatment for each subject will vary according to the number of cycles completed; the number of cycles will depend on whether the subject benefits from the treatment. The study consists of a 4-week screening period, a 21-day treatment cycle (repeatable, depending on the presence/absence of clinical benefit), EOT visit after discontinuation of treatment, and 2 follow-up visits 28 days (± 2 days) and 84 days (± 5 days) after the last study medication.

Start Date28 Feb 2021

Sponsor / Collaborator

Hopp Pharmaceutical (Guangzhou) Co., Ltd.

100 Clinical Results associated with Porustobart

100 Translational Medicine associated with Porustobart

100 Patents (Medical) associated with Porustobart

Literatures (Medical) associated with Porustobart

01 Aug 2025·CLINICAL CANCER RESEARCH

Porustobart (HBM4003) plus Toripalimab as Second-Line Therapy in Patients with Advanced Hepatocellular Carcinoma: A Multicenter, Open-Label, Phase I Study

Article

Author: Liu, Tian ; Tao, Xiaolu ; Hao, Jihui ; Luo, Ruixuan ; Shen, Jie ; Xu, Aibing ; Luo, Ming ; Cao, Nan ; Gao, Meijuan ; Zhang, Jingdong ; Yao, Jun ; Xu, Chongyuan ; Xin, Guijie ; Zhang, Yanqiao ; Zheng, Fei ; Yang, Di ; Yu, Ge ; Niu, Junqi ; Zhang, Ningning ; He, Yebo ; Qin, Shukui ; Chen, Yajin ; Guo, Yabing ; Wang, Gang ; Zhang, Shuwen ; Gu, Shanzhi

Abstract:

Purpose::

The study was conducted to evaluate porustobart (HBM4003), a novel anti–cytotoxic T lymphocyte–associated protein 4 monoclonal antibody, combined with toripalimab as second-line therapy in advanced hepatocellular carcinoma (HCC).

Patients and Methods::

This phase I study included two cohorts of patients with advanced HCC: cohort 1 included patients who were anti–PD-1/PD-L1 naïve and had received first-line anti-VEGFR tyrosine kinase inhibitor, and cohort 2 included patients who had failed prior first-line anti–PD-1/PD-L1 and anti-VEGF/VEGFR therapies. Porustobart (0.45 mg/kg) and toripalimab (240 mg) were administered every 21 days. The primary endpoint was the objective response rate (ORR).

Results::

In total, 16 patients were enrolled in cohort 1 and 12 in cohort 2. In the 26 patients with evaluable efficacy data, the ORR was 23.1% (95% confidence interval, 9.0–43.6). Cohort 1 exhibited an ORR of 40.0%, whereas cohort 2 presented no objective response. The median progression-free survival was 4.2 months, with 5.7 months for cohort 1 and 3.8 months for cohort 2. Biomarker exploration revealed higher abundance of intratumoral regulatory T cells in responders before treatment and a substantial elevation of CD4+Ki67+ and CD8+Ki67+ T cells after treatment. For safety, treatment-emergent adverse events were reported in 27 patients (96.4%), and treatment-related adverse events were reported in 25 patients (89.3%), among whom 13 (46.5%) had grade ≥3 treatment-related adverse events. Serious adverse events were observed in 12 patients (42.9%), and treatment-related serious adverse events were observed in nine patients (32.1%).

Conclusions::

The combination of porustobart and toripalimab shows promising efficacy as a second-line therapy in anti–PD-1/PD-L1–naïve patients with advanced HCC and a manageable safety profile.

01 Jun 2025·EClinicalMedicine

Efficacy and safety of HBM4003 combined with toripalimab in refractory neuroendocrine neoplasms: a multicenter, phase II study

Article

Author: Chen, Kai ; Luo, Ruixuan ; Zhang, Panpan ; Shen, Lin ; Song, Lijie ; Li, Feng ; Yang, Jianwei ; Tao, Xiaolu ; He, Yebo ; Zheng, Fei ; Yang, Di ; Cao, Nan ; Lu, Ming

Background:

High-grade neuroendocrine neoplasms (NENs) have limited treatment options following first-line platinum-based chemotherapy, often resulting in poor clinical outcomes. Dual immune checkpoint blockade targeting CTLA-4 and PD-1 offers a synergistic approach by enhancing T-cell activation and amplifying anti-tumor immune responses. This study evaluates the efficacy and safety of HBM4003, a novel fully human anti-CTLA-4 monoclonal antibody, in combination with toripalimab, a PD-1 inhibitor, in patients with high-grade, refractory NENs.

Methods:

This multicenter, open-label, phase II study enrolled patients with neuroendocrine carcinomas (NECs), grade 3 NETs (NETs G3), and mixed neuroendocrine-non-neuroendocrine neoplasms (MiNENs) who had progressed on first-line therapy. Patients received HBM4003 at either 0.3 mg/kg or 0.45 mg/kg in combination with toripalimab (240 mg) every three weeks. The primary endpoint was the objective response rate (ORR). The study was registered on ClinicalTrials.gov (NCT05167071).

Findings:

Between December 2021 and May 2024, a total of 29 patients were enrolled (NECs, n = 22; NETs G3, n = 3; MiNENs, n = 4). All patients had previously undergone chemotherapy, with 11 receiving ≥2 lines of therapy. Thirteen (13) patients had lung metastasis and 18 had liver metastasis. Patients were assigned to the HBM4003 0.3 mg/kg cohort (n = 13) or the 0.45 mg/kg cohort (n = 16), with 26 patients forming the efficacy analysis set. The overall ORR was 34.6% (95% confidence intervals [CI], 17.2-55.7), and the disease control rate (DCR) was 65.4% (95% CI, 44.3-82.8). Median progression-free survival (PFS) and overall survival (OS) were 4.0 months (95% CI, 1.6-5.1) and 21.8 months (95% CI, 16.7-not estimated [NE]), respectively. For 19 NEC patients in the efficacy analysis set, the ORR and DCR were 36.8% (95% CI, 16.3-61.6) and 68.4% (95% CI, 43.4-87.4), respectively. The median PFS was 4.0 months (95% CI, 1.6-5.4), while the median OS was not reached (95% CI, 13.5-NE). Of the 29 NEN patients receiving at least one dose of study treatment, all patients experienced at least one treatment-related adverse event (TRAE), with 10 (34.5%) experiencing grade ≥3 TRAE and eight (27.6%) experiencing grade ≥3 immune-related adverse events.

Interpretation:

HBM4003 combined with toripalimab demonstrated promising anti-tumor activity and manageable safety in patients with refractory NENs, supporting further investigation of this combination therapy.

Funding:

This study was funded by Harbour BioMed (Shanghai) Co. Ltd.

01 Oct 2024·Journal for ImmunoTherapy of Cancer

Toripalimab in combination with HBM4003, an anti-CTLA-4 heavy chain-only antibody, in advanced melanoma and other solid tumors: an open-label phase I trial

Article

Author: Li, Rongqing ; Zheng, Fei ; Jiang, Yu ; Gao, Meijuan ; Tang, Bixia ; Zhao, Shuai ; Tao, Xiaolu ; Gao, Quanli ; Duan, Rong ; Qi, Meng ; Huang, Gang ; Cui, Chuanliang ; Zhang, Xiaoshi ; Ren, Xiubao ; Guo, Jun ; Yao, Li ; Lee, Michael ; Chen, Jing ; Fang, Meiyu ; Chi, Zhihong ; Luo, Ruixuan ; Chen, Yu ; Li, Feng

Background:

HBM4003 is a novel anti-CTLA-4 heavy chain-only antibody, designed to enhance Treg ablation and antibody-dependent cell-mediated cytotoxicity while ensuring a manageable safety profile. This phase I trial investigated the safety, pharmacokinetics, immunogenicity and preliminary efficacy of HBM4003 plus with anti-PD-1 antibody toripalimab in patients with advanced solid tumors, especially focusing on melanoma.

Methods:

The multicenter, open-label phase I trial was divided into two parts: dose-escalation phase (part 1) and dose-expansion phase (part 2). In part 1, HBM4003 was administered at doses of 0.03, 0.1, 0.3 mg/kg in combination with toripalimab with fixed dosage of 240 mg every 3 weeks. The recommended phase II dose (RP2D) was used in the expansion phase. Primary endpoints were safety and RP2D in part 1 and objective response rate (ORR) in part 2. Biomarkers based on cytokines and multiplex immunofluorescence staining were explored.

Results:

A total of 40 patients received study treatment, including 36 patients treated with RP2D of HBM4003 0.3 mg/kg plus toripalimab 240 mg every 3 week. 36 participants (90.0%) experienced at least one treatment-related adverse event (TRAE), of which 10 (25.0%) patients experienced grade ≥3 TRAEs and 5 (12.5%) experienced immune-mediated adverse events (irAEs) with maximum severity of grade 3. No grade 4 or 5 irAEs occurred. Efficacy analysis set included 32 melanoma patients treated with RP2D and with available post-baseline imaging data. The ORRs of anti-PD-1/PD-L1 treatment-naïve subgroup and anti-PD-1/PD-L1 treatment-failed subgroup were 33.3% and 5.9%, respectively. In mucosal melanoma, the ORR of the two subgroups were 40.0% and 10.0%, respectively. Baseline high Treg/CD4+ratio in the tumor serves as an independent predictive factor for the efficacy of immunotherapy.

Conclusions:

HBM4003 0.3 mg/kg plus toripalimab 240 mg every 3 week demonstrated manageable safety in solid tumors and no new safety signal. Limited data demonstrated promising antitumor activity, especially in PD-1 treatment-naïve mucosal melanoma.

Trial registration number:

NCT04727164.

News (Medical) associated with Porustobart

25 Feb 2026

·endpoints.news

China-to-West pace escalates as Frontier, Harbour do licensing deals with GSK, Solstice

The first two China-to-West licensing deals of the Chinese New Year have landed. GSK will again return to the world’s most bustling biopharma dealmaking region with a two-siRNA pact with Frontier Biotechnologies for undisclosed immunological diseases. Meanwhile, a new UK and US biotech called Solstice Oncology has been formed around an anti-CTLA-4 asset from Harbour BioMed, a multinational biotech that has done deals with AstraZeneca and a handful of other drugmakers. Each deal could be worth about $1 billion. They represent two of the most common types of drug pacts that have taken place amid China’s ascent: a large pharma directly shopping and a new Western biotech forming around an asset derived from a China biotech. With the Monday tie-ups, at least 19 China-to-West drug pacts have been forged so far this year, signaling the region’s continued momentum amid a boom in innovation and pharma’s appetite for pipeline refilling. GSK will pay $40 million upfront and up to $963 million in biobucks for exclusive global access to Frontier’s two siRNAs. One is at the IND stage, and the other is a preclinical candidate. Frontier said it will take one of the experimental assets through Phase 1 in China. Frontier CEO Dong Xie said in a statement that the agreement will help the biotech expand its international collaborations and potentially get to commercialization. GSK has done deals with multiple Chinese biotechs in recent years, including with Hengrui and Hansoh Pharma. It’s also acquired companies with core assets from China, including Aiolos Bio and RAPT Therapeutics. Now, it’s delving further into siRNAs with Frontier. The gene-silencing modality has gained steam lately, particularly in areas like cardiometabolic diseases. That has included multiple deals with Chinese biotechs, such as Madrigal’s MASH partnership with Suzhou Ribo Life Science earlier this month. Harbour’s deal is with a mysterious new biotech backed by a group of what it calls “major venture capital investors.” According to a UK regulatory filing last week, Solstice has addresses in the UK and Boston. Its only listed director is former Mural Oncology CEO Caroline Loew. Mural ended development of its IL-2 drug last year and was bought by XOMA Royalty. Harbour will get $50 million in upfront cash, $5 million in near-term cash and a $50 million equity interest in the new biotech. The biotech could also get up to $1.1 billion in biobucks. The deal revolves around ex-China rights to a clinical-stage monoclonal antibody called porustobart, or HBM4003. The anti-CTLA-4 medicine has gone through a Phase 1 study as a monotherapy, Harbour said on its website. The drugmaker has said it plans to test it for melanoma, non-small cell lung cancer and other solid tumors. “By co-founding a company along with others and becoming a shareholder, we are participating in the building of a global biotechnology company alongside experienced investors, focused on the development of HBM4003,” Harbour CEO Jingsong Wang said in a statement. That structure allows Harbour to “remain engaged in advancing the asset toward global development,” Wang added. Harbour has offices in Shanghai; Rotterdam; Cambridge, MA; Beijing and elsewhere. It’s quickly grown into a dealmaking powerhouse, slinging pacts with AstraZeneca, Bristol Myers Squibb, Otsuka and others. It’s also been involved in NewCo deals like the Solstice one. Last year, Windward Bio launched an asthma drug with Harbour and its partner Kelun. The content above comes from the network. if any infringement, please contact us to modify.

License out/inAcquisition

25 Feb 2026

·www.biospace.com

Harbour Co-Founds Cancer Startup, Hands Off Clinical-Stage Antibody

iStock, Czanner Solstice Oncology will gain an exclusive worldwide license to Harbour BioMed’s porustobrt, an anti-CTLA-4 antibody currently being studied for melanoma, colorectal cancer and other malignancies in China. Chinese biotech Harbour BioMed is taking part in the formation of Solstice Oncology alongside a group of unnamed venture capital investors, giving the startup exclusive global access to its lead asset HBM4003. Under the terms of Tuesday’s deal, Harbour will receive $105 million upfront, a sum that covers a $50 million immediate cash payment, $5 million in near-term commitments and a $50 million equity stake in Solstice. The startup will also be on the hook for up to approximately $1.1 billion in development and commercialization milestones, according to the company’s news release . HBM4003, also called porustobart, is a fully human monoclonal heavy chain-only antibody designed to target the CTLA-4 protein, according to Harbour’s website . Via this mechanism, the molecule boosts the immune system’s cancer-killing activity while also limiting toxic side effects. For its investment, Solstice will receive the exclusive right to develop and market HBM4003 outside the Greater China region. It is unclear which particular disease Solstice will be targeting, but under Harbour’s wing, the asset is being developed for melanoma, colorectal cancer (CRC), hepatocellular cancer and neuroendocrine neoplasms, all running in China. Phase II data released in October 2025 demonstrated a 34.8% objective response rate in heavily pretreated patients with metastatic CRC, resulting in a median progression-free survival of 4.2 months. “By co-founding a company along with others and becoming a shareholder, we are participating in the building of a global biotechnology company,” Harbour CEO Jingsong Wang said in a statement. Headquartered in Shanghai, Harbour has established a strong presence in Western markets. The biotech has one office in Natick, Massachusetts and another in Rotterdam, Netherlands. In December 2025, Bristol Myers Squibb paid $90 million upfront for access to the biotech’s Harbour Mice platform, aiming to advance multispecific antibodies for undisclosed indications. The agreement also includes up to $1.035 billion in development and commercial milestones. China BMS Forges $1B+ Antibody Alliance With Chinese Firm Harbour BMS is Harbour’s second powerhouse partner this year after the Chinese biotech signed a potential $4.68 billion deal with AstraZeneca in March. December 17, 2025 · 1 min read · Tristan Manalac A few months earlier, in March 2025, Harbour signed a similar deal with AstraZeneca . For $175 million upfront, the pharma gained the option to license two preclinical immunology programs, as well as the ability to nominate additional targets. The agreement, also centered on multispecific antibodies, could yield a $4.4 billion prize for Harbour.

License out/inPhase 2Phase 1ADC

24 Feb 2026

·www.fiercebiotech.com

Harbour ships CTLA-4 asset to form new biotech in $1.1B biobucks deal

Harbour will receive $105 million up front, consisting of $50 million cash, $5 million in near-term payments and more than $50 million of equity in Solstice. \n Harbour BioMed is setting sail as the Solstice begins, riding the waves of biobucks potential that could reach heights up to $1.1 billion.Newly formed Solstice Oncology has inked an exclusive development and commercialization deal for Harbour’s HBM4003, an anti-CTLA-4 monoclonal heavy chain-only antibody (HCAb). The terms of the agreement exclude Greater China.In exchange for rights to the clinical-stage asset, Harbour will receive a $105 million upfront package comprising $50 million in cash, $5 million in near-term payments and more than $50 million in equity in Solstice. “By co-founding a company along with others and becoming a shareholder, we are participating in the building of a global biotechnology company alongside experienced investors, focused on the development of HBM4003, one of our leading antibody programs,” Harbour CEO and co-founder Jingsong Wang, M.D., Ph.D., said in a release.“This structure enables long-term value creation while allowing Harbour BioMed to remain engaged in advancing the asset toward global development,” he added.Harbour will also have the chance to reel in up to $1.1 billion biobucks tied to the completion of certain future events, plus tiered royalties on sales outside of China. While the deal announcement didn’t disclose the therapeutic area Solstice will be pursuing for HBM4003, one could assume from the new company’s name and mechanism of the program that it will be in cancer.As for Harbour, the company is largely focused on immunology and oncology development. The company leverages its platform, coded Harbour Mice, to create fully human monoclonal antibodies in the two areas.Shanghai-based Harbour has significant presence in Cambridge, Massachusetts, as well as in Rotterdam in the Netherlands. In December, the company announced a partnership with Bristol Myers Squibb for several discovery programs, with biobucks up to $1.035 billion on the table.

License out/in

100 Deals associated with Porustobart

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatocellular Carcinoma	Phase 2	-	Harbour BioMed (Shanghai) Co., Ltd.	-
Melanoma	Phase 2	-	Harbour BioMed (Shanghai) Co., Ltd.	-
Renal Cell Carcinoma	Phase 2	-	Harbour BioMed (Shanghai) Co., Ltd.	-
Metastatic Colorectal Carcinoma	Phase 1	China	Hopp Pharmaceutical (Guangzhou) Co., Ltd.	28 Dec 2021
Neuroendocrine tumor of pancreas	Phase 1	China	Hopp Pharmaceutical (Guangzhou) Co., Ltd.	28 Dec 2021
Non Functioning Pancreatic Endocrine Tumor	Phase 1	China	Hopp Pharmaceutical (Guangzhou) Co., Ltd.	28 Dec 2021
Advanced Hepatocellular Carcinoma	Phase 1	China	Nona Biosciences Suzhou Co. Ltd.	15 Dec 2021
Advanced Neuroendocrine Neoplasm	Phase 1	China	Nona Biosciences Suzhou Co. Ltd.	14 Oct 2021
Neuroendocrine Carcinoma	Phase 1	China	Nona Biosciences Suzhou Co. Ltd.	14 Oct 2021
Advanced Lung Non-Small Cell Carcinoma	Phase 1	China	Nona Biosciences Suzhou Co. Ltd.	28 Apr 2021

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05167071 (Company_Website) Manual	Phase 2	Metastatic Microsatellite Stable Colorectal Carcinoma Last line \| Third line Microsatellite Stable (MSS)	24	HBM4003 (0.3 mg/kg) + Tislelizumab (200 mg)	qjxmmjuban(zjtbqoypld) = sgzslkashv wshvlpnzrz (ykaiznjmtv ) View more	Positive	23 Oct 2025
Pubmed Manual	Phase 1	Advanced Hepatocellular Carcinoma Second line	28	PorustobartPorustobart (HBM4003) + Toripalimab	xliuaqqkek(irbosjqkqn) = eyuxsurddg eehyvaghtz (lzpexivvvh, 9.0 - 43.6) View more	Positive	01 Aug 2025
				PorustobartPorustobart (HBM4003) + ToripalimabToripalimab (anti-PD-1/PD-L1 naïve and had received first-line anti-VEGFR tyrosine kinase inhibitor)	xliuaqqkek(irbosjqkqn) = qcrlesvojr eehyvaghtz (lzpexivvvh ) View more
NCT05167071 (HBM4003 combined with toripalimab in refractory neuroendocrine neoplasms, Pubmed \| EClinicalMedicine)	Phase 2	Neuroendocrine Tumors	29	HBM4003 0.3 mg/kg + Toripalimab 240 mg	nwakbspxri(grjkvavsec) = fbkfumqzyc ilfkfdoxoc (ewzgqbchss, 17.2 - 55.7) View more	Positive	01 Jun 2025
NCT04727164 (Pubmed) Manual	Phase 1	Solid tumor \| Melanoma	40	Toripalimab + HBM4003	fkezryxmif(pevjddxazv) = boaiplxryb xlzcclalfd (hncttiugac ) View more	Positive	04 Oct 2024
				Toripalimab + HBM4003 (anti-PD-1/PD-L1 treatment-naïve)	eydtsknqjq(bpzznqxxob) = csmpctqxfj mntyidbqaw (hynompufyn ) View more
NCT05149027 (ASCO 12023 \| ASCO 22023) Manual	Phase 1	Hepatocellular Carcinoma	28	Toripalimab+Porustobart (pts who failed previous anti-VEGFR multikinase inhibitor(s) treatment while have not received anti-PD-(L)1 treatment + Cohort 1)	piuihpykcc(uevvxghatj) = agrhinnxcx uxicvfetdu (vyejrisosx, 21.3 - 73.4) View more	Positive	26 May 2023
				Toripalimab+Porustobart (pts who failed previous anti-PD-(L)1 and anti-VEGF(R) treatments + Cohort 2)	piuihpykcc(uevvxghatj) = jbunuqzkff uxicvfetdu (vyejrisosx, 0.2 - 41.3) View more
NCT05167071 (AACR2023) Manual	Phase 1	Advanced Neuroendocrine Neoplasm Microsatellite Stable (MSS)	16	porustobart+toripalimab	sjkohzzatc(edauadumjx) = netqbbxxqw zoftfaqvir (dhkdmszodo ) View more	Positive	14 Apr 2023
				porustobart+toripalimab (neuroendocrine carcinoma)	sjkohzzatc(edauadumjx) = atvdygelus zoftfaqvir (dhkdmszodo ) View more
NCT04727164 (ESMO_IO2022) Manual	Phase 1	Locally Advanced Melanoma First line	40	HBM4003 0.03-0.3 mg/kg+Toripalimab 240 mg (Cohort A)	cbmxrzunau(ormrmejrsp) = pdslwftmns zripdkiyod (wvwioyryap, 44.9 - 92.2) View more	Positive	08 Dec 2022
				HBM4003 0.03-0.3 mg/kg+Toripalimab 240 mg (Cohort B)	cbmxrzunau(ormrmejrsp) = ikpihhyvlv zripdkiyod (wvwioyryap, 14.2 - 61.7) View more

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