Drugs / Osemitamab
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT05608785 | Jan → Dec 2023 | gastric cancer, gastroesophageal cancer | Henan Cancer Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT04495296 | Aug 2020 → Jun 2027 expected | — | Transcenta Therapeutics (Hangzhou) Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04396821 | May 2020 → Jun 2027 expected | gastric cancer, gastroesophageal cancer, malignant pancreatic neoplasm | Transcenta Therapeutics (Hangzhou) Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05190575 | Jan 2022 → May 2023 | biliary tract neoplasm | Shanghai Zhongshan Hospital | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT06093425 Comparator | Jun 2027 → Oct 2029 expected | gastric cancer, gastroesophageal cancer | Transcenta Therapeutics (Hangzhou) Co., Ltd. | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 21
| Date | Issuer | Release |
|---|---|---|
| 2025-12-05 | Transcenta Therapeutics (Hangzhou) Co., Ltd. | Results Transcenta Therapeutics Presents Updated Efficacy Data from the Phase I/II Transtar102 Trial of Osemitamab plus Nivolumab and CAPOX in First-line G/GEJ Cancer at ESMO Asia transcenta.com ↗
In the 26 patients with CLDN18.2 expression ≥40%, ≥2+ and known PD-L1 CPS, the median PFS reached 16.6 months, with an ORR of 68% and a median DoR of 18 months at a 25.8-month median follow-up. |
| 2025-06-02 | Transcenta Therapeutics (Hangzhou) Co., Ltd. | Results Transcenta Strengthens Promise for Osemitamab (TST001) for G/GEJ Cancer with OS Data from First-Line Triple Combo Trial Unveiled at 2025 ASCO Annual Meeting transcenta.com ↗
The confirmed objective response rate (cORR) was 68% with a median duration of response (mDoR) of 16.5 months in this population. |
| 2024-09-19 | Transcenta Therapeutics (Hangzhou) Co., Ltd. | Results Transcenta Updates Encouraging Efficacy Data from First-line Triple Combo Trial of Osemitamab (TST001) for G/GEJ Cancer at ESMO 2024 transcenta.com ↗
The results showed that in patients with known CLDN18.2 and PD-L1 status, the median progression-free survival (mPFS) reached 14.2 months for those with H/M CLDN18.2 expression, with a confirmed objective response rate of 68%. |
| 2024-05-24 | Transcenta Therapeutics (Hangzhou) Co., Ltd. | Results Transcenta Debuts Encouraging Phase II Data from First-line Triple Combo Trial of Osemitamab (TST001) for G/GEJ Cancer at ASCO 2024 transcenta.com ↗
The results showed that median progression-free survival (mPFS) reached 12.6 months in patients with H/M CLDN18.2 expression, any PD-L1 CPS, as well as in the 80% of patients with PD-L1 CPS<5. |
| 2023-12-13 | Transcenta Therapeutics (Hangzhou) Co., Ltd. | Results Transcenta Announces the Publication of Preclinical Results of [177Lu]Lu-TST001 Radionuclide Antibody Conjugate as Potential Novel Treatment Option for Metastatic Gastric Cancer in the European Journal of Nuclear Medicine and Molecular Imaging transcenta.com ↗
In this preclinical studies, [ 177 Lu]Lu-TST001 demonstrated significant antitumor efficacy with acceptable toxicity. |
| 2023-10-23 | Transcenta Therapeutics (Hangzhou) Co., Ltd. | Results Transcenta Unveils Updated Efficacy Data from Osemitamab (TST001) Plus CAPOX as First-Line Treatment for G/GEJ Cancer Study at ESMO 2023 transcenta.com ↗
Latest data reveals a 55% confirmed response rate, median duration of response (DoR) and median progression-free survival (PFS) of more than 12 months for all patients treated in the expansion cohort |
| 2023-10-04 | Transcenta Therapeutics (Hangzhou) Co., Ltd. | Regulatory FDA Grants Transcenta Clearance to Proceed with Global Phase III Trial of Osemitamab (TST001) as First-Line Treatment for Gastric/Gastroesophageal Cancer Patients transcenta.com ↗
This milestone marks a crucial advancement in the progression of Osemitamab (TST001) toward becoming a global therapy that elevates the current standard of care for HER2-negative metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma. |
| 2023-07-07 | Transcenta Therapeutics (Hangzhou) Co., Ltd. | Regulatory Transcenta Received Approvals from China CDE and South Korea MFDS to Initiate TranStar 301 Global Phase III Pivotal Trial of Osemitamab (TST001) transcenta.com ↗ |
| 2023-06-30 | Transcenta Therapeutics (Hangzhou) Co., Ltd. | Results Transcenta Presented PFS Data by CLDN18.2 Expression Level from Phase I/II Study of Osemitamab (TST001) plus CAPOX as the First-Line Treatment of Advanced G/GEJ Cancer at 2023 ESMO GI Annual Congress transcenta.com ↗ |
| 2023-06-06 | Transcenta Therapeutics (Hangzhou) Co., Ltd. | Results Transcenta Presents Updated Data of Osemitamab (TST001) in Combination with CAPOX as a First-Line Treatment of G/GEJ Cancer at 2023 ASCO Annual Meeting transcenta.com ↗
The data showed that Osemitamab (TST001) has durable anti-tumor activity in all the study population including both high and low to median CLDN18.2-expressing gastric cancer. |
| 2023-03-29 | Transcenta Therapeutics (Hangzhou) Co., Ltd. | Regulatory Transcenta’s Osemitamab (TST001) Targeting Claudin18.2 Granted Orphan Drug Designation for Treatment of Pancreatic Cancer transcenta.com ↗
Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Osemitamab (TST001), its high affinity humanized ADCC-enhanced anti-Claudin18.2 monoclonal antibody, for the treatment of patients with pancreatic cancer. |
| 2023-03-03 | Transcenta Therapeutics (Hangzhou) Co., Ltd. | Results Results of CLDN18.2-targeting Immuno-PET Probe for Non-invasive Imaging in Gastrointestinal Tumors Published transcenta.com ↗
today announces that the study results of its CLDN18.2-targeting Immuno-PET probe [89Zr]Zr-DFO-TST001 for non-invasive imaging in gastrointestinal tumors have been published on Journal of Pharmaceutical Analysis. |
| 2022-09-13 | Transcenta Therapeutics (Hangzhou) Co., Ltd. | Results Transcenta Releases Encouraging Interim Safety and Efficacy Data of the TST001 (Osemitamab) and Chemotherapy Combination Expansion Cohort for First Line Claudin18.2 Positive Gastric Cancer at ESMO Congress 2022 transcenta.com ↗
In first line treatment of advanced or metastatic G/GEJ cancer, early interim data of the first 15 patients with measurable disease receiving the combination of TST001 (Osemitamab) with CAPOX demonstrated a partial response rate of 73.3% and a disease control rate of 100% per RECIST1.1. |
| 2022-06-02 | Transcenta Therapeutics (Hangzhou) Co., Ltd. | Results Transcenta Releases Phase I Clinical Data of TST001 in Combination with CAPOX as the First Line Treatment of Advanced and Metastatic G/GEJ Cancer at ASCO 2022 transcenta.com ↗
The data showed that TST001 in combination with CAPOX as the first line treatment of patients with advanced and metastatic G/GEJ cancer is well tolerated and encouraging preliminary anti-tumor activities have been observed. |
| 2022-03-10 | Transcenta Therapeutics (Hangzhou) Co., Ltd. | Results Transcenta Presented Safety / Tolerability and Preliminary Anti-tumor Activity Data in Gastric and Pancreatic Cancers of TST001 Monotherapy from China Phase I Clinical Trial at the 2022 International Gastric Cancer Congress transcenta.com ↗
9 patients were DLT evaluable with no DLT reported and MTD has not been reached. |
| 2021-07-28 | Transcenta Therapeutics (Hangzhou) Co., Ltd. | Regulatory Transcenta Announces Orphan Drug Designation Granted to TST001 for Treatment of Gastric and Gastroesophageal Junction Cancer transcenta.com ↗
the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to TST001 |
| 2021-07-02 | Transcenta Therapeutics (Hangzhou) Co., Ltd. | Results Transcenta Provides Program Update for Anti-Claudin18.2 Monoclonal Antibody TST001 and Reports Promising Early Anti-Tumor Responses in Patients with Gastric Cancer transcenta.com ↗
One heavily pretreated late-line gastric cancer patient out of the three patients at 6mg/kg dose cohort in the monotherapy dose-escalation study achieved partial response according to RECIST1.1 criteria after 6 weeks of treatment. |
| 2020-04-20 | Transcenta Therapeutics (Hangzhou) Co., Ltd. | Regulatory Transcenta Received IND Clearance from FDA for Initiating Clinical Trials for its Novel Humanized Claudin 18.2 Monoclonal Antibody TST001 transcenta.com ↗
As of today, TST001 has received clearance from both FDA and China National Medical Products Administration (NMPA) to initiate clinical trials in patients with metastatic solid tumors. |
| 2020-04-10 | Transcenta Therapeutics (Hangzhou) Co., Ltd. | Regulatory Transcenta Receives IND Clearance for Novel Humanized Claudin 18.2 Monoclonal Antibody TST001 to Initiate Clinical Trials in China transcenta.com ↗
Transcenta, a global biotherapeutics company that fully integrates antibody-based biotherapeutics discovery, R&D and manufacturing, today announced that its subsidiary Mabspace Biosciences (Suzhou) Co., Limited has received the clearance from the National Medical Products Administration (NMPA) to initiate Phase I clinical trials in China for its Claudin 18.2 (CLDN18.2) humanized monoclonal antibody, TST001. |
| 2020-01-20 | Transcenta Therapeutics (Hangzhou) Co., Ltd. | Regulatory Transcenta Announces Acception by NMPA of IND Application of a Novel Humanized Claudin 18.2 Monoclonal Antibody transcenta.com ↗
has been accepted by the Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) of China. |
| 2020-01-16 | Transcenta Therapeutics (Hangzhou) Co., Ltd. | Regulatory Transcenta Attends 38th Annual J.P. Morgan Healthcare Conference, CEO Dr. Xueming Qian Delivers Speech and Shares Progress transcenta.com ↗
The investigational new drug (IND) of this asset has been filed with both NMPA and FDA. |
All press releases naming this drug 31 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Osemitamab | “Combination of Osemitamab (TST001), Pembrolizumab and Chemotherapy as First-line Therapy in Advanced or Metastatic GC/GEJ Adenocarcinoma” NCT06093425 ↗ |
| Known as | MSB-018 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095388 ↗ |
| Known as | TST001 | “Combination of Osemitamab (TST001), Pembrolizumab and Chemotherapy as First-line Therapy in Advanced or Metastatic GC/GEJ Adenocarcinoma” NCT06093425 ↗ |
| Modality | Monoclonal antibody | “a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody” NCT04396821 ↗ |
| Route | Intravenous | “Dosed every 2 weeks IV with TST001, starting dose is 1 mg/kg, multiple dose levels will be tested.” NCT04396821 ↗ |
| Target | CLDN18 | “a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody” NCT04396821 ↗ |