An Open, Multicenter Study on the Treatment of Recurrent and Metastatic Triple-negative Breast Cancer Guided by Cell Surface Protein Typing (HIM) in Triple-negative Breast Cancer

To explore the efficacy and safety of treatment for recurrent and metastatic advanced first-line triple-negative breast cancer guided by cell surface protein-based subtyping (HIM).

Start Date01 Apr 2025

Sponsor / Collaborator

Fudan University

NCT06706219

/ Not yet recruitingPhase 2IIT

Efficacy and Safety of Sacituzumab Tirumotecan (SKB264) in Combination With Pembrolizumab in Patients With Initially Unresectable Stage III Non-small Cell Lung Cancer (NSCLC): a Multi-center Phase II Study

This study is a phase 2 open-label, multicenter clinical study to evaluate the efficacy and safety SKB264 in combination with pembrolizumab in patients with unresectable stage III non-small cell lung cancer.

Start Date31 Mar 2025

Sponsor / Collaborator

Hunan Cancer Hospital

NCT06841354

/ Not yet recruitingPhase 3

A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as a Monotherapy and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less Than 10 (TroFuse-011)

Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to people treated with chemotherapy.

Start Date24 Mar 2025

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

100 Clinical Results associated with Sacituzumab tirumotecan

100 Translational Medicine associated with Sacituzumab tirumotecan

100 Patents (Medical) associated with Sacituzumab tirumotecan

Literatures (Medical) associated with Sacituzumab tirumotecan

15 Jul 1999·BloodQ1 · MEDICINE

Fibrinogen Receptor Antagonist-Induced Thrombocytopenia in Chimpanzee and Rhesus Monkey Associated With Preexisting Drug-Dependent Antibodies to Platelet Glycoprotein IIb/IIIa

Q1 · MEDICINE

Article

Author: Bednar, Bohumil ; Holahan, Marie A. ; Hartman, George D. ; Gould, Robert J. ; Cook, Jacquelynn J. ; Cunningham, Michael E. ; Bednar, Rodney A. ; Jumes, Patricia A.

Most clinical trials with fibrinogen receptor antagonists (FRAs) have been associated with thrombocytopenia. This report describes the occurrence of thrombocytopenia in one chimpanzee and one rhesus monkey upon administration of potent FRAs. Chimpanzee A-264 experienced profound thrombocytopenia on two occasions immediately upon intravenous administration of two different potent FRAs, L-738,167 and L-739,758. However, an equally efficacious antiaggregatory dose of another potent antagonist, L-734,217, caused no change in platelet count. These compounds did not affect platelet count in five other chimpanzees or numerous other nonhuman primates. Flow cytometric analysis showed drug-dependent antibodies (DDAbs) in the plasma of chimpanzee A-264 that bound to platelets of chimpanzees, humans, and all other primates tested only in the presence of the compounds that induced thrombocytopenia. Rhesus monkey 94-R021 experienced thrombocytopenia upon administration of a different antagonist, L-767,679, and several prodrugs that are converted into the active form, L-767,679, in the blood. More than 20 other FRAs, including those that induced thrombocytopenia in chimpanzee A-264, had no effect on platelet count in this monkey. Flow cytometric measurements again identified DDAbs that reacted with platelets of all primates tested and required the presence of L-767,679. Screening for DDAbs in the plasma of 1,032 human subjects with L-738,167 and L-739,758 demonstrated that the incidence of these preexisting antibodies in this population was 0.8% ± 0.6% and 1.1% ± 0.6%, respectively.

Frontiers in oncology

Preclinical profiles of SKB264, a novel anti-TROP2 antibody conjugated to topoisomerase inhibitor, demonstrated promising antitumor efficacy compared to IMMU-132

Article

Author: Xie, Jia ; Chen, Yang ; Zhao, Xi ; Long, Hu ; Ji, Yafei ; Pu, Yuzhi ; Xu, Mingyu ; Tan, Yuping ; Song, Hongmei ; Cheng, Yezhe ; Tian, Qiang ; Yuan, Xiaoxi ; Huang, Xiuying

Purpose:

The aim of this study was to improve the intratumoral accumulation of an antibody–drug conjugate (ADC) and minimize its off-target toxicity, SKB264, a novel anti-trophoblast antigen 2 (TROP2) ADC that was developed using 2-methylsulfonyl pyrimidine as the linker to conjugate its payload (KL610023), a belotecan-derivative topoisomerase I inhibitor. The preclinical pharmacologic profiles of SKB264 were assessed in this study.

Methods:

The in vitro and in vivo pharmacologic profiles of SKB264, including efficacy, pharmacokinetics–pharmacodynamics (PK-PD), safety, and tissue distribution, were investigated using TROP2-positive cell lines, cell-derived xenograft (CDX), patient-derived xenograft (PDX) models, and cynomolgus monkeys. Moreover, some profiles were compared with IMMU-132.

Results:

In vitro, SKB264 and SKB264 monoclonal antibody (mAb) had similar internalization abilities and binding affinities to TROP2. After cellular internalization, KL610023 was released and inhibited tumor cell survival. In vivo, SKB264 significantly inhibited tumor growth in a dose-dependent manner in both CDX and PDX models. After SKB264 administration, the serum or plasma concentration/exposure of SKB264 (conjugated ADC, number of payload units ≥1), total antibody (Tab, unconjugated and conjugated mAb regardless of the number of the payload units), and KL610023 in cynomolgus monkeys increased proportionally with increasing dosage from 1 to 10 mg/kg. The linker stability of SKB264 was significantly enhanced as shown by prolonged payload half-life in vivo (SKB264 vs. IMMU-132, 56.3 h vs. 15.5 h). At the same dose, SKB264’s exposure in tumor tissue was 4.6-fold higher than that of IMMU-132.

Conclusions:

Compared with IMMU-132, the longer half-life of SKB264 had a stronger targeting effect and better antitumor activity, suggesting the better therapeutic potential of SKB264 for treating TROP2-positive tumors.

Frontiers in oncology

Corrigendum: Preclinical profiles of SKB264, a novel anti-TROP2 antibody conjugated to topoisomerase inhibitor, demonstrated promising antitumor efficacy compared to IMMU-132

Author: Chen, Yang ; Xie, Jia ; Zhao, Xi ; Long, Hu ; Ji, Yafei ; Pu, Yuzhi ; Xu, Mingyu ; Song, Hongmei ; Tan, Yuping ; Cheng, Yezhe ; Tian, Qiang ; Yuan, Xiaoxi ; Huang, Xiuying

[This corrects the article DOI: 10.3389/fonc.2022.951589.].

News (Medical) associated with Sacituzumab tirumotecan

23 hours ago

·synapse.patsnap.com

Sacituzumab tirumotecan: A Quick Look at Its R&D Progress and Clinical Results from the 2024 AACR

TROP2 (trophoblast cell surface antigen 2) is commonly over-expressed in non-small cell lung cancer (NSCLC) and associated with poor prognosis. SKB264 (MK-2870) is a TROP2 ADC developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor. The linker is affected by both extracellular pH-sensitive cleavage and intracellular enzymatic cleavage within tumor cells, which leads to efficiently release payload inside tumor cells as well as within tumor microenvironment to exert its anti-tumor effects. On April 5, 2024, the 2024 AACR present the updated data from a Phase 2 expansion cohort for patients (pts) with advanced NSCLC. Sacituzumab tirumotecan's R&D Progress Sacituzumab tirumotecan (MK-2870) is an antibody drug conjugate (ADC) that targets Trop-2, a protein found in various types of cancers. It has shown potential therapeutic benefits in treating a wide range of neoplasms, skin and musculoskeletal diseases, digestive system disorders, respiratory diseases, urogenital diseases, other diseases, and endocrinology and metabolic diseases. According to the Patsnap Synapse, Sacituzumab tirumotecan was developed by Sichuan Kelun Pharmaceutical Co., Ltd., a reputable organization in the pharmaceutical industry. It has reached the highest phase of development, which is the New Drug Application (NDA) or Biologics License Application (BLA) phase, both globally and in China. And the clinical trial distributions for Sacituzumab tirumotecan are primarily in the United States, China and United Kingdom. The key indication is PD-L1 positive Non-Small Cell Lung Cancer. Detailed Clinical Result of Sacituzumab tirumotecan This non-randomized, sequential assignment, open-labeled clinical study (NCT04152499) was aimed to efficacy and safety of anti-TROP2 ADC SKB264 (MK-2870) for previously treated advanced NSCLC. In this study, pts with previously treated advanced NSCLC were enrolled to receive SKB264 at 5 mg/kg Q2W until disease progression or unacceptable toxicity (KL264-01, NCT04152499). Tumor assessment was performed every 8 weeks per RECIST v1.1 assessed by investigator. The result showed that as of Nov 22, 2023, 43 NSCLC pts had been enrolled. Median follow-up was 17.2 months (mo). 21 pts with EGFR wild type had received median prior 3 regimens of therapy including anti-PD-1/L1 inhibitors. 22 pts with EGFR mutant had progressed on or after TKI therapy, 50% of whom also failed at least one line of chemotherapy. Updated efficacy results are shown in the Table. Overall, 30 pts (69.8%) experienced Grade ≥3 treatment-related adverse events (TRAEs). The most common Grade ≥3 TRAEs were neutrophil count decreased (34.9%), anemia (30.2%), WBC count decreased (25.6%), stomatitis (9.3%), and rash (7.0%). No TRAEs leading to treatment discontinuation or deaths occurred. No drug-related ILD/pneumonitis was reported. It can be concluded that the updated data continues to demonstrate that SKB264 monotherapy delivers promising clinical efficacy with manageable toxicity in pretreated advanced NSCLC pts. A Phase 3 global study of SKB264 in pts with 3L+ EGFR mutant NSCLC (NCT06074588) and a Phase 3 study of SKB264 in China in pts with 2L EGFR mutant NSCLC (NCT05870319) are ongoing. The content above comes from the network. if any infringement, please contact us to modify.

13 Feb 2025

·pipelinereview.com

Study Results Abstracts From Kelun-Biotech's TROP2 ADC Sacituzumab Tirumotecan (sac-TMT) At 2025 ASCO Genitourinary Cancers Symposium

CHENGDU, China I February 12, 2025 I At the American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium 2025, to be held in San Francisco, USA, from Feb. 13-15, 2025, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd （”Kelun-Biotech” will present efficacy and safety results from the Phase 1/2 KL264-01/MK-2870-001 study (NCT04152499) of its anti-TROP2 ADC sacituzumab tirumotecan (sac-TMT, formerly SKB-264/MK-2870) as monotherapy in patients with unresectable, locally advanced or metastatic urothelial carcinoma (UC) who progressed on or after prior anti-cancer therapies. These findings will be presented in a poster session on February 14, 2025, local time (Abstract #796). The abstract for the above study was also published on the official website of the ASCO GU Cancers Symposium 2025 on February 10, 2025, local time. UC Eligible participants had histologically/cytologically confirmed locally advanced or metastatic UC, had experienced progression of disease on ≥1 prior line of platinum-based therapy and had received prior anti-PD-(L)1 therapy; platinum-ineligible patients were eligible if they received prior anti-PD-(L)1 therapy (prior neoadjuvant/adjuvant therapy counted as a line of therapy if patients progressed within 12 months). Patients had Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1 and measurable disease by CT/MRI. Patients received sac-TMT 5 mg/kg every two weeks (Q2W) until progression of disease, unacceptable toxicity or withdrawal of consent. As of data cutoff on June 30, 2024, 49 treated patients had a minimum follow-up of ≥9 weeks. Eleven patients received sac-TMT as 2L treatment; 38 received sac-TMT as 3L+ treatment. Median age was 62 and 61 years old, respectively; most patients were Asian (82%; 100%). Median (range) follow-up was 9.5 (7.5-16.2) months and 11.7 (7.8-17.4) months, respectively. Among all patients, objective response rate (ORR) was 31%. Efficacy data are shown below: CI=Confidence interval, CR=Complete response, PR=Partial response, SD=Stable disease, PD=Progression of disease, DoR=Duration of response, PFS=Progression-free survival, OS=Overall survival, NE=Not evaluable. “+” No progressive disease or death as of last disease assessment. a Includes all patients as-treated. b Kaplan-Meier method for censored data. By safety data cutoff (May 21, 2024), grade ≥3 treatment-related adverse events (TRAEs) occurred in 59% of patients. The most common Grade 3-4 TRAEs were anemia (39%), neutrophil count decreased (29%), white blood cells count decreased (16%), stomatitis (12%), and platelet count decreased (8%), which were generally reversible with dose modifications and/or supportive care. No Grade 5 TRAEs occurred; TRAEs led to sac-TMT discontinuation in one patient. About sac-TMT Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells. Previously, the National Medical Products Administration (NMPA) has approved the marketing of sac-TMT in China for 2L+ advanced triple negative breast cancer (TNBC), and accepted two supplemental new drug applications (sNDA) seeking the approvals of sac-TMT monotherapy for 2L/3L EGFR-mutant non-small cell lung cancer (NSCLC). In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan). About Kelun-Biotech Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world’s leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/ . SOURCE: Sichuan Kelun-Biotech Biopharmaceutical Co.

Clinical ResultDrug ApprovalASCO

13 Feb 2025

·www.prnewswire.com

Study Results Abstracts From Kelun-Biotech's TROP2 ADC Sacituzumab Tirumotecan (sac-TMT) At 2025 ASCO Genitourinary Cancers Symposium

CHENGDU, China, Feb. 12, 2025 /PRNewswire/ -- At the American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium 2025, to be held in San Francisco, USA, from Feb. 13-15, 2025, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd （"Kelun-Biotech" will present efficacy and safety results from the Phase 1/2 KL264-01/MK-2870-001 study (NCT04152499) of its anti-TROP2 ADC sacituzumab tirumotecan (sac-TMT, formerly SKB-264/MK-2870) as monotherapy in patients with unresectable, locally advanced or metastatic urothelial carcinoma (UC) who progressed on or after prior anti-cancer therapies. These findings will be presented in a poster session on February 14, 2025, local time (Abstract #796). The abstract for the above study was also published on the official website of the ASCO GU Cancers Symposium 2025 on February 10, 2025, local time. UC Eligible participants had histologically/cytologically confirmed locally advanced or metastatic UC, had experienced progression of disease on ≥1 prior line of platinum-based therapy and had received prior anti-PD-(L)1 therapy; platinum-ineligible patients were eligible if they received prior anti-PD-(L)1 therapy (prior neoadjuvant/adjuvant therapy counted as a line of therapy if patients progressed within 12 months). Patients had Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1 and measurable disease by CT/MRI. Patients received sac-TMT 5 mg/kg every two weeks (Q2W) until progression of disease, unacceptable toxicity or withdrawal of consent. As of data cutoff on June 30, 2024, 49 treated patients had a minimum follow-up of ≥9 weeks. Eleven patients received sac-TMT as 2L treatment; 38 received sac-TMT as 3L+ treatment. Median age was 62 and 61 years old, respectively; most patients were Asian (82%; 100%). Median (range) follow-up was 9.5 (7.5-16.2) months and 11.7 (7.8-17.4) months, respectively. Among all patients, objective response rate (ORR) was 31%. Efficacy data are shown below: CI=Confidence interval, CR=Complete response, PR=Partial response, SD=Stable disease, PD=Progression of disease, DoR=Duration of response, PFS=Progression-free survival, OS=Overall survival, NE=Not evaluable. "+" No progressive disease or death as of last disease assessment. a Includes all patients as-treated. b Kaplan-Meier method for censored data. By safety data cutoff (May 21, 2024), grade ≥3 treatment-related adverse events (TRAEs) occurred in 59% of patients. The most common Grade 3-4 TRAEs were anemia (39%), neutrophil count decreased (29%), white blood cells count decreased (16%), stomatitis (12%), and platelet count decreased (8%), which were generally reversible with dose modifications and/or supportive care. No Grade 5 TRAEs occurred; TRAEs led to sac-TMT discontinuation in one patient. About sac-TMT Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells. Previously, the National Medical Products Administration (NMPA) has approved the marketing of sac-TMT in China for 2L+ advanced triple negative breast cancer (TNBC), and accepted two supplemental new drug applications (sNDA) seeking the approvals of sac-TMT monotherapy for 2L/3L EGFR-mutant non-small cell lung cancer (NSCLC). In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan). About Kelun-Biotech Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit . SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultASCODrug ApprovalADC

100 Deals associated with Sacituzumab tirumotecan

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Triple Negative Breast Cancer	CN	Sichuan Kelun Botai Biomedicine Co., Ltd.	22 Nov 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
EGFR-mutated non-small Cell Lung Cancer	NDA/BLA	CN	Sichuan Kelun Botai Biomedicine Co., Ltd.	20 Aug 2024
Platinum-Sensitive Ovarian Carcinoma	Phase 3	-	Merck Sharp & Dohme Corp.	05 Mar 2025
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	CN	Sichuan Kelun Pharmacy Institute Co., Ltd.	19 Oct 2024
Cervical Squamous Cell Carcinoma	Phase 3	US	MSD R&D (China) Co. Ltd.	24 Jul 2024
Cervical Squamous Cell Carcinoma	Phase 3	CN	MSD R&D (China) Co. Ltd.	24 Jul 2024
Cervical Squamous Cell Carcinoma	Phase 3	JP	MSD R&D (China) Co. Ltd.	24 Jul 2024
Cervical Squamous Cell Carcinoma	Phase 3	AR	MSD R&D (China) Co. Ltd.	24 Jul 2024
Cervical Squamous Cell Carcinoma	Phase 3	AU	MSD R&D (China) Co. Ltd.	24 Jul 2024
Cervical Squamous Cell Carcinoma	Phase 3	AT	MSD R&D (China) Co. Ltd.	24 Jul 2024
Cervical Squamous Cell Carcinoma	Phase 3	BE	MSD R&D (China) Co. Ltd.	24 Jul 2024

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04152499 (MK-2870-001, ASCO_GU2025) Manual	Phase 1/2	Advanced Urothelial Carcinoma Last line \| Third line \| Second line	49	sac-TMT 5 mg/kg (UC 2L)	bhzbzhabbn(aotqkjkbxp) = dryvwyzjdf rzewznznhm (pepifobdph, 16.7 - 76.6) View more	Positive	13 Feb 2025
				sac-TMT 5 mg/kg (UC 3L+)	bhzbzhabbn(aotqkjkbxp) = bltccbbary rzewznznhm (pepifobdph, 13.4 - 43.1) View more
ptiTROP-Breast01 (NEWS 1 \| NEWS 2) Manual	Phase 3	Triple Negative Breast Cancer PR Negative \| ER Negative \| HER2 Negative	263	芦康沙妥珠单抗	fxgwkqlxxz(qafzuedcco) = cdpmdcqjqr zkpgnugjoe (bbfyjrywhn ) View more	Positive	29 Sep 2024
				化疗	fxgwkqlxxz(qafzuedcco) = fzmtxcnzyq zkpgnugjoe (bbfyjrywhn ) View more
NCT05351788 (OptiTROP-Lung01, NEWS) Manual	Phase 2	Advanced Lung Non-Small Cell Carcinoma PD-L1	103	sac-TMT 5 mg/kg Q3W + KL-A167 KL-A167 1200 mg Q3W	iyyuvbuehn(puiacrjuhv) = qbpwfqhmwe ffdhwslpnz (vtjgyhvdjc ) View more	Positive	29 Sep 2024
				sac-TMT 5 mg/kg Q2W + KL-A167 KL-A167 900 mg Q2W	iyyuvbuehn(puiacrjuhv) = tdiusrwhsv ffdhwslpnz (vtjgyhvdjc ) View more
NCT05347134 (OptiTROP-Breast01, ESMO2024) Manual	Phase 3	Triple Negative Breast Cancer	-	Sacituzumab tirumotecan (sac-TMT)	ragmiszlng(eayqrukbnp) = wnttmilwjs idwanfladk (tvfsqhcljr ) View more	Positive	16 Sep 2024
				Treatment of physician’s choice (TPC: eribulin, capecitabine, gemcitabine, or vinorelbine)	ragmiszlng(eayqrukbnp) = qqdavfvgri idwanfladk (tvfsqhcljr ) View more
NCT04152499 (KL264-01, ESMO 12024 \| ESMO 22024) Manual	Phase 2	Ovarian Cancer \| Advanced Endometrial Carcinoma TROP2 Expression	84	Sacituzumab tirumotecan (sac-TMT) 5 mg/kg Q2W (advanced endometrial carcinoma (EC))	epdgfburld(ujowebfmgb) = uphndepjxo lxizowyvoz (jibuzexxqr ) View more	Positive	15 Sep 2024
				sacituzumab tirumotecan (sac-TMT) 5 mg/kg Q2W (ovarian cancer (OC))	epdgfburld(ujowebfmgb) = ftqtitnwkh lxizowyvoz (jibuzexxqr ) View more
NCT05642780 (SKB264-Ⅱ-06, ESMO2024) Manual	Phase 2	Uterine Cervical Cancer	38	Sacituzumab tirumotecan 3 Pembrolizumabolizumab 400 mg	twwdyrbwmu(uvpxzjrzhc) = xruykvfynr imshjwvvkn (wdfldlgrip ) View more	Positive	15 Sep 2024
				Sacituzumab tirumotecan + Pembrolizumab (pre-treated with anti-PD-1 based therapy)	cnsvrqfbii(zumrkrvxzl) = hburspipuj injxljdbjr (wyeukbpnqe )
NCT05351788 (OptiTROP-Lung01, ASCO2024) Manual	Phase 2	Non-Small Cell Lung Cancer First line	103	SKB264 5 mg/kg Q3W + KL-A167 1200 mg Q3W	vszoamsqsa(hyjqnugozv) = fijsqrtcia cyhgkskdju (fmmcenoluc ) View more	Positive	24 May 2024
				SKB264 5 mg/kg Q2W + KL-A167 900 mg Q2W	vszoamsqsa(hyjqnugozv) = ntzvpyierb cyhgkskdju (fmmcenoluc ) View more
NCT05347134 (OptiTROP-Breast01, ASCO2024) Manual	Phase 3	Triple Negative Breast Cancer Third line TROP2	263	Sacituzumab tirumotecan (SKB264/MK-2870)	jjegtwkdmh(tmuwltjexh) = ttfdngqwzo dkbxvmtitk (qpxskzbvkr, 4.3 - 7.2) Met View more	Positive	24 May 2024
				Chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine)	jjegtwkdmh(tmuwltjexh) = sdnzfafvpl dkbxvmtitk (qpxskzbvkr, 1.6 - 2.7) Met View more
NCT04152499 (KL264-01, AACR2024) Manual	Phase 2	Advanced Lung Non-Small Cell Carcinoma EGFR Gene Mutation Negative \| EGFR Mutation (Activating)	43	SKB264 (MK-2870)	nsbsphznsf(qydyjqfvnz) = oflcqlvosq eydzklmnzb (wioggspebt ) View more	Positive	05 Apr 2024
				SKB264 (MK-2870) (EGFR mutant)	nsbsphznsf(qydyjqfvnz) = psvffbrqwo eydzklmnzb (wioggspebt ) View more
NCT04152499 (KL264-01, AACR2024) Manual	Phase 2	Gastrooesophageal junction cancer Second line \| Third line	48	SKB264 (MK-2870) 5 mg/kg Q2W	ewkfuaiztm(kuglcpyzne) = tsoxtfqnoy fwjssocvpe (qgzhifopdr ) View more	-	05 Apr 2024

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