osemitamab (TST001) / Transcenta - LARVOL DELTA

First-line osemitamab (TST001) plus nivolumab and CAPOX for advanced G/GEJ cancer (TranStar102): Updated results of cohort G from a phase I/IIa study. (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT04495296 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Metastases • P1/2 data • Gastric Cancer • Gastroesophageal Cancer • Oncology

TransStar101: A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=150 | Active, not recruiting | Sponsor: Suzhou Transcenta Therapeutics Co., Ltd. | Trial completion date: Dec 2024 ➔ Sep 2025 | Trial primary completion date: Nov 2024 ➔ May 2025

Monotherapy • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

TranStar102: A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=320 | Recruiting | Sponsor: Suzhou Transcenta Therapeutics Co., Ltd. | Trial completion date: Nov 2024 ➔ May 2025 | Trial primary completion date: Aug 2024 ➔ Feb 2025

Metastases • Trial completion date • Trial primary completion date • Biliary Tract Cancer • Colorectal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CLDN18 • HER-2

TransStar101: A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=150 | Active, not recruiting | Sponsor: Suzhou Transcenta Therapeutics Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jun 2024 ➔ Nov 2024

Combination therapy • Enrollment closed • Metastases • Monotherapy • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Claudin 1, 4, 6 and 18 isoform 2 as targets for the treatment of cancer (Review). (PubMed, Int J Mol Med) - "The human/humanized anti‑CLDN18.2 mAb osemitamab, and ADCs AZD0901, IBI343 and LM‑302, with single‑agent ORRs of 28‑60%, have been tested in phase III clinical trials. In addition, bsAbs, CAR T cells and their derivatives targeting CLDN4, 6 or 18.2 are in phase I and/or II clinical trials. AZD0901, IBI343, zolbetuximab and the anti‑CLDN1 mAb ALE.C04 have been granted fast track designation or priority review designation by the US Food and Drug Administration."

Journal • Review • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor • CLDN1 • CLDN18 • CLDN4 • CLDN6

Transcenta Updates Encouraging Efficacy Data from First-line Triple Combo Trial of Osemitamab (TST001) for G/GEJ Cancer at ESMO 2024 (PRNewswire) - P1/2 | N=320 | Transtar102 (NCT04495296) | Sponsor: Suzhou Transcenta Therapeutics Co., Ltd. | "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%. The vast majority of these patients are PD-L1 CPS<5....As of the cutoff date, the median OS was not reached because of the limited number of events, the 12-month survival rate for the overall population (82 patients) in this cohort was 73.8% (95% CI: 62.0- 82.4%)....All patients experienced treatment-related adverse events (TRAE). The most common TRAEs were hypoalbuminaemia, nausea and vomiting, most of them were of CTC AE grade 1 or 2 and manageable."

P1/2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Osemitamab (TST001) plus nivolumab and CAPOX as the first-line therapy for the patients with advanced G/GEJ cancer (TranStar102) (ESMO 2024) - P1/2 | "Updated data indicate that the combination of TST001 plus nivolumab and CAPOX as the 1L treatment for patients with G/GEJ cancer is safe and well tolerated with very encouraging anti-tumor activities, especially for patients with high/medium CLDN18.2 expression when cross comparing to historical data."

Clinical • IO biomarker • Metastases • Gastric Cancer • Gastrointestinal Cancer • Oncology • CLDN18 • HER-2 • PD-L1

First-line osemitamab (TST001) plus nivolumab and capox for advanced g/GEJ cancer (TranStar102): Results of cohort G from a phase I/IIa study. (ASCO 2024) - P1/2 | "Preliminary data indicate that the combination of TST001 6mg/kg Q3W plus nivolumab and CAPOX for the 1 st line treatment of patients with G/GEJ cancer is safe and well tolerated with encouraging preliminary anti-tumor activities. Updated clinical data, including PFS and DoR will be reported at the time of the conference."

Clinical • IO biomarker • Metastases • P1/2 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • CLDN18 • HER-2 • PD-L1

Transcenta Debuts Encouraging Phase II Data from First-line Triple Combo Trial of Osemitamab (TST001) for G/GEJ Cancer at ASCO 2024 (PRNewswire) - P1/2 | N=320 | TranStar102 (NCT04495296) | Sponsor: Suzhou Transcenta Therapeutics Co., Ltd. | "Transcenta Holding Limited...today announced the results from the Phase I/IIa Cohort-G data for Osemitamab (TST001) plus Nivolumab and CAPOX as the first-line treatment of patients with advanced G/GEJ cancer...As of the cut-off date, 82 patients had been dosed with a median follow-up of 12.6 months...with mPFS of 12.6 months in the patients with high or medium expression (H/M), 8.5 months in patients with low expression (L) and 6.7 months in the rest patients (R) respectively. Confirmed response rate was respectively 68%, 61.1% and 50% respectively...The main toxicities are on-target-off-tumor effects that are manageable, including nausea, hypoalbuminemia and vomiting, mostly grade 1 or 2."

P1/2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

TranStar101: osemitamab, a novel CLDN18.2 inhibitor, in solid tumors (YouTube) - "Yelena Janjigian, MD...presents the results of the Phase I/IIa TranStar101 trial (NCT04396821) evaluating the safety, tolerability, and pharmacokinetics of the monoclonal antibody osemitamab with nivolumab. Osemitamab is a next generation inhibitor of claudin 18.2 (CLDN18.2), an important biomarker expressed in locally advanced or metastatic solid tumors. Dr Janjigan briefly highlights the findings of Phase III studies on zolbetuximab, another anti-CLDN18.2 monoclonal antibody, with promising results for progression free survival. This TranStar101 trial successfully employed a combinatory treatment approach to evaluate the use of chemotherapy, a checkpoint inhibitor targeting PD-1, and osemitamab."

Interview • Video

A Phase I/IIa clinical trial (TranStar101) to evaluate the safety, tolerability and pharmacokinetics of OSEMITAMAB administered as monotherapy or in combination with nivolumab or standard of care in patients with locally advanced or metastatic solid tumors (AACR 2024) - P1/2 | "Cohort A includes combination of osemitamab, nivolumab, and mFOLFOX6 as the 1st line treatment for G/GEJ cancer... Osemitamab as monotherapy or in combination with nivolumab or mFOLFOX plus nivolumab is well tolerated and safe with a PK profile consistent with other studies (TranStar 102 study -NCT04495296). TranStar 101 is currently ongoing. More information will be shared."

Clinical • Combination therapy • Metastases • Monotherapy • P1/2 data • PK/PD data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

Development of Claudin 18.2 IHC 14G11 pharmDx as a clinical trial assay for the clinical development of anti-claudin 18.2 monoclonal antibody osemitamab (TST001) in gastric and gastroesophageal junction adenocarcinoma (AACR 2024) - "Analytical verification testing indicates Claudin 18.2 IHC 14G11 pharmDx is a sensitive, specific, and precise assay for detecting Claudin 18.2 in gastric and GEJ adenocarcinoma. Claudin 18.2 IHC 14G11 pharmDx for Investigational Use Only/for Performance Evaluation Only will be used for patient selection in the upcoming phase III trial of gastric/GEJ adenocarcinoma where applicable ethics committee and regulatory approvals have been granted."

Clinical • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

ESP2E- Novel technologies for precision medicine: Agilent Avida targeted sequencing and Claudin 18.2 IHC assay for Transcenta Therapeutics' Osemitamab program (AACR 2024) - "In collaboration with Transcenta, Agilent is developing an IHC companion diagnostic for Claudin 18.2. The assay is being used for patient selection in Transcenta's clinical phase 3 program."

Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

TranStar102: A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=320 | Recruiting | Sponsor: Suzhou Transcenta Therapeutics Co., Ltd. | Trial completion date: Apr 2024 ➔ Nov 2024 | Trial primary completion date: Dec 2023 ➔ Aug 2024

Metastases • Trial completion date • Trial primary completion date • Biliary Tract Cancer • Colorectal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CLDN18 • HER-2

Transcenta Announces Collaboration with Agilent to Develop a Claudin18.2 Companion Diagnostic to Support Osemitamab (TST001) Global Phase III Trial (PRNewswire) - "Transcenta Holding Limited...and Agilent Technologies, announce a collaboration to develop a Claudin18.2 (CLDN18.2) companion diagnostic to support TranStar301 global Phase III pivotal trial of Osemitamab (TST001) in combination with Nivolumab and chemotherapy as first-line treatment in patients with CLDN18.2 expressing locally advanced or metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma."

Diagnostic • Licensing / partnership • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology

[Lu]Lu-labeled anti-claudin-18.2 antibody demonstrated radioimmunotherapy potential in gastric cancer mouse xenograft models. (PubMed, Eur J Nucl Med Mol Imaging) - "In preclinical studies, [Lu]Lu-TST001 demonstrated significant antitumor efficacy with acceptable toxicity. It exhibits strong potential for clinical translation, providing a new promising treatment option for CLDN18.2-overexpressing tumors, including GC."

Journal • Preclinical • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Solid Tumor • CLDN18

Osemitamab (TST001): An ADCC enhanced humanized anti-CLDN18.2 mab, demonstrated improved efficacy in combination with anti-PD-L1/PD-1 mab and oxaliplatin/5-FU in preclinical tumor models (ESMO 2023) - "In two CLDN18.2+/PD-L1+ mouse syngeneic models, Osemitamab combined with Atezolizumab exhibited significantly higher tumor growth inhibition (TGI) than the single agents...Conclusions PD-L1 upregulation after Osemitamab treatment provides a rationale for combination of Osemitamab and anti-PD-L1/PD-1 mAb. And the potential synergistic effect of Osemitamab and GC standard of care (SoC: anti-PD-1 mAb + Oxa/5-FU) in preclinical tumor models supports Osemitamab in combination with SoC chemotherapy +/- nivolumab in G/GEJ patients."

Combination therapy • IO biomarker • Preclinical • Oncology • CLDN18

Pharmacokinetics, pharmacodynamics and exposure response analyses of osemitamab in patients with locally advanced or metastatic solid tumors (ESMO 2023) - P1/2 | "Anti-tumor activity data from 58 patients with 1L G/GEJ adenocarcinoma treated with osemitamab and capecitabine and oxaliplatin (CAPOX) showed patients with average concentration in 56 days above 24 μg/mL tended to have a better ORR. Grade 2+ nausea/vomiting are found to be associated with osemitamab exposure; however, simulations demonstrated the proportion of patients that developed Grade 2+ nausea or vomiting by 6 months were just slightly higher (< 10% in difference) following 6 mg/kg Q3W than 3 mg/kg Q3W. Conclusions Osemitamab at 6mg/kg Q3W or 4mg/kg Q2W are predicted to have favorable PK/PD/safety profiles and might be associated with better ORR in combination with SOC compared to the lower doses."

Clinical • Metastases • PK/PD data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

First-line TST001 plus capecitabine and oxaliplatin (CAPOX) for advanced G/GEJ cancer with CLDN18.2 positive overall survival data from study transtar102-Cohort C (ESMO 2023) - P1/2 | "Encouraging anti-tumor activities have been observed regardless of the CLDN18.2 expression levels, including expression as low as ≥10% tumor cells staining ≥1+, <40% tumor cells staining <2+ or 3+. Overall survival data will be presented."

Clinical • Metastases • Gastric Cancer • Gastrointestinal Cancer • Oncology • CLDN18

Combination of TST001, Nivolumab and Chemotherapy as First-line Therapy in Advanced or Metastatic GC/GEJ Adenocarcinoma (clinicaltrials.gov) - P3 | N=950 | Not yet recruiting | Sponsor: Suzhou Transcenta Therapeutics Co., Ltd.

Metastases • New P3 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • PD-L1

Transcenta Unveils Updated Efficacy Data from Osemitamab (TST001) Plus CAPOX as First-Line Treatment for G/GEJ Cancer Study at ESMO 2023 (PRNewswire) - P1/2a | N=320 | Transtar102 (NCT04495296) | Sponsor: Bristol-Myers Squibb | "Transcenta Holding Limited...announces that it has presented updated efficacy data from the expansion cohort of the TranStar102 of Osemitamab (TST001) plus CAPOX chemotherapy study as the first-line treatment of advanced G/GEJ Cancer at the ESMO Congress 2023 in Madrid, Spain...Cohort C from Transtar102 study...was designed to explore the safety and efficacy of Osemitamab (TST001) plus CAPOX as first-line treatment in advanced G/GEJ cancer...Among the 49 patients, 42 patients had measurable lesions at baseline and at least one post-baseline tumor assessment, and 28 of them achieved partial response, with 23 as confirmed response (54.8%, 23/42)...The median overall survival (OS) was not reached because of the limited number of events, the 12-month survival rate for the overall population of cohort-C (64 patients, all doses) was 88.9% (95% CI: 74.2, 95.4)."

P1/2 data • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

FDA Grants Transcenta Clearance to Proceed with Global Phase III Trial of Osemitamab (TST001) as First-Line Treatment for Gastric/Gastroesophageal Cancer Patients (PRNewswire) - "Transcenta Holding Limited...announces that FDA has granted it clearance to proceed with TranStar 301 global Phase III pivotal trial of Osemitamab (TST001) in combination with Nivolumab and chemotherapy as first-line treatment in patients with HER2-negative, CLDN18.2 expressing locally advanced or metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma. This clearance marks a major step forward in the global development of Osemitamab (TST001) and another important milestone following the approvals by the Center for Drug Evaluation (CDE) in China and MFDS in South Korea for the Phase III pivotal trial of Osemitamab (TST001) in July 2023."

IND • New P3 trial • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Transcenta to Present Three Study Results at ESMO 2023 (PRNewswire) - "Transcenta Holding Limited...announces that it is going to present three posters highlighting study results from ongoing trials related to Osemitamab (TST001) at the 2023 European Society of Medical Oncology (ESMO) Congress including updated efficacy and PK/PD analysis data from the phase 2 study of Osemitamab (TST001)/CAPOX in CLDN18.2 positive first line G/GEJC as well as preclinical data on the combination study of Osemitamab (TST001) with PD1 inhibitor."

P2 data • PK/PD data • Preclinical • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

First-line TST001 plus Nivolumab and CAPOX for Advanced G/GEJ Cancer (TranStar102) - Results of Cohort G from a Phase I/IIa Study (ESMO 2023) - No abstract available

Clinical • Metastases • P1/2 data • Gastric Cancer • Gastrointestinal Cancer • Oncology

TST001 in Patients With CLDN18.2 Positive Previously Treated Advanced Biliary Tract Cancer (clinicaltrials.gov) - P2 | N=8 | Completed | Sponsor: Shanghai Zhongshan Hospital | Recruiting ➔ Completed | N=40 ➔ 8 | Trial completion date: Jul 2024 ➔ May 2023

Enrollment change • Metastases • Trial completion • Trial completion date • Biliary Cancer • Biliary Tract Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18