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    1m
    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, Suzhou Transcenta Therapeutics Co., Ltd. | Trial completion date: Apr 2024 --> Nov 2024 | Trial primary completion date: Dec 2023 --> Aug 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
    |
    HER-2 negative
    |
    Opdivo (nivolumab) • cisplatin • gemcitabine • paclitaxel • capecitabine • oxaliplatin • osemitamab (TST001)
    1m
    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."
    Licensing / partnership
    |
    osemitamab (TST001)
    5ms
    [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.
    Preclinical • Journal
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression • CLDN18.2 positive • CLDN18.2 overexpression • CLDN1 overexpression
    |
    osemitamab (TST001)
    7ms
    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, Suzhou Transcenta Therapeutics Co., Ltd.
    New P3 trial • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Opdivo (nivolumab) • 5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • osemitamab (TST001)
    10ms
    TST001 in Patients With CLDN18.2 Positive Previously Treated Advanced Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=8, Completed, Shanghai Zhongshan Hospital | Recruiting --> Completed | N=40 --> 8 | Trial completion date: Jul 2024 --> May 2023
    Trial completion • Enrollment change • Trial completion date • Metastases
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression
    |
    osemitamab (TST001)
    10ms
    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)
    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
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression • CLDN18.2 positive • CLDN18.2 overexpression • CLDN1 positive
    |
    capecitabine • oxaliplatin • osemitamab (TST001)
    10ms
    Pharmacokinetics, pharmacodynamics and exposure response analyses of osemitamab in patients with locally advanced or metastatic solid tumors (ESMO 2023)
    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 • PK/PD data • Metastases
    |
    CLDN18 (Claudin 18)
    |
    capecitabine • oxaliplatin • osemitamab (TST001)
    1year
    Development of a CLDN18.2-targeting immuno-PET probe for non-invasive imaging in gastrointestinal tumors. (PubMed, J Pharm Anal)
    A dosimetry estimation study showed that the effective dose of &lsqb;Zr]Zr-DFO-TST001 was 0.0705 mSv/MBq, which is within the range of acceptable doses for nuclear medicine research. Taken together, these results suggest that Good Manufacturing Practices produced by this immuno-positron emission tomography probe can detect CLDN18.2-overexpressing tumors.
    Journal
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression • CLDN18.2 positive • CLDN18.2 overexpression
    |
    osemitamab (TST001)
    1year
    Osemitamab plus capecitabine and oxaliplatin (CAPOX) as the first-line treatment of advanced G/GEJ cancer – updated efficacy data per claudin 18.2 expression level from study TranStar102/TST001-1002-cohort C (ESMO-GI 2023)
    Funding: Suzhou Transcenta Therapeutics Co., Ltd.Background: Claudin18.2 antibody plus chemotherapy is a clinically validated approach for patients with high CLDN18.2 expressing tumors, which has been proven by zolbetuximab. Osemitamab plus CAPOX as first-line treatment for patients with G/GEJ cancer demonstrated good safety and tolerability. Encouraging anti-tumor activities have been observed regardless of the CLDN18.2 expression levels above 10%, 1+ per central LDT assay.
    Clinical • Metastases
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression • CLDN18.2 overexpression
    |
    capecitabine • oxaliplatin • Vyloy (zolbetuximab) • osemitamab (TST001)
    1year
    TST001-1002: 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, Suzhou Transcenta Therapeutics Co., Ltd. | Phase classification: P1 --> P1/2 | N=210 --> 320 | Trial completion date: Jan 2023 --> Apr 2024 | Trial primary completion date: Aug 2022 --> Dec 2023
    Phase classification • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
    |
    HER-2 negative
    |
    Opdivo (nivolumab) • cisplatin • gemcitabine • paclitaxel • capecitabine • oxaliplatin • osemitamab (TST001)
    over1year
    TST001 (a high affinity humanized anti-claudin18.2 monoclonal antibody) in combination with nivolumab plus capecitabine and oxaliplatin as first-line or with nivolumab as late-line treatment in locally advanced and metastatic gastric/gastroesophageal junction (G/GEJ) cancer: Design of cohorts from a phase I/IIa study (TST001-1002). (ASCO-GI 2023)
    Combinations with nivolumab are being explored in the US study too (NCT04396821). Clinical trial information: NCT04495296.
    Clinical • P1/2 data • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18) • CLDN8 (Claudin 8)
    |
    HER-2 negative • CLDN18.2 positive
    |
    Opdivo (nivolumab) • capecitabine • oxaliplatin • osemitamab (TST001)
    over1year
    Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes (clinicaltrials.gov)
    P1/2; N=45; Not yet recruiting; Sponsor:Henan Cancer Hospital
    New P1/2 trial • IO biomarker
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Focus V (anlotinib) • capecitabine • oxaliplatin • benmelstobart (APL-502) • osemitamab (TST001) • fidasimtamab (IBI315)
    over1year
    A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=124, Recruiting, Suzhou Transcenta Therapeutics Co., Ltd. | Phase classification: P1 --> P1/2
    Phase classification • Combination therapy • Metastases
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression
    |
    Opdivo (nivolumab) • osemitamab (TST001)
    almost2years
    Updated report of a phase I study of TST001, a humanized anti-CLDN18.2 monoclonal antibody, in combination with capecitabine and oxaliplatin (CAPOX) as a first-line treatment of advanced G/GEJ cancer (ESMO 2022)
    Conclusions TST001 in combination with CAPOX in first-line G/GEJ cancer patients is safe and encouraging anti-tumor activities have been observed. Additional data from the dose expansion cohort will be updated at the meeting.
    Clinical • P1 data • Combination therapy
    |
    CLDN18 (Claudin 18)
    |
    capecitabine • oxaliplatin • osemitamab (TST001)
    almost2years
    TST001 in Patients With CLDN18.2 Positive Previously Treated Advanced Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=40, Recruiting, Shanghai Zhongshan Hospital | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression
    |
    osemitamab (TST001)
    2years
    A phase I study of TST001, a high affinity humanized anti-CLDN18.2 monoclonal antibody, in combination with capecitabine and oxaliplatin (CAPOX) as a first-line treatment of advanced G/GEJ cancer. (ASCO 2022)
    TST001 in combination with CAPOX in first line gastric cancer patients is safe and encouraging anti-tumor activities have been observed. Additional data from the 6 mg/kg dose expansion cohort will be updated at the meeting.
    Clinical • P1 data • Combination therapy
    |
    CLDN18 (Claudin 18) • CLDN8 (Claudin 8)
    |
    CLDN18.2 expression • CLDN18.2 overexpression
    |
    capecitabine • oxaliplatin • osemitamab (TST001)
    over2years
    TST001 in Patients With CLDN18.2 Positive Previously Treated Advanced Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Shanghai Zhongshan Hospital
    Clinical • New P2 trial
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression
    |
    osemitamab (TST001)
    over3years
    A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=210, Recruiting, Mabspace Biosciences (Suzhou) Co., Ltd. | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
    |
    HER-2 negative
    |
    osemitamab (TST001)
    almost4years
    A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=210, Not yet recruiting, Mabspace Biosciences (Suzhou) Co., Ltd.
    Clinical • New P1 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
    |
    HER-2 negative
    |
    osemitamab (TST001)