^
10d
A Phase I/II Study of HY05350 in Mesothelin(MSLN)-Positive Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=262, Recruiting, Sichuan Huiyu Pharmaceutical Co., Ltd | Not yet recruiting --> Recruiting
Enrollment open
14d
First-in-human study of a thorium-227-labeled mesothelin-targeting antibody-chelator conjugate (MSLN-TTC), in patients with malignant mesothelioma and other solid tumors. (PubMed, ESMO Open)
MSLN-TTC showed good tolerability, but the maximum tolerated dose could not be determined due to discontinuations after antidrug antibody formation. Stable disease was observed in 12 out of 36 patients.
P1 data • Journal • First-in-human
|
MSLN (Mesothelin)
|
thorium (227Th) anetumab corixetan (BAY 2287411)
1m
Characterization of CAR-T cellular kinetics and efficacy in solid tumor patients with and without prior lymphodepletion chemotherapy using a PBPK-PD model. (PubMed, J Pharmacokinet Pharmacodyn)
Model was developed based on digitized individual level CK, categorical antitumor activity and percentage tumor antigen expression dataset from following phase-1 dose-escalation studies: (A) anti-mesothelin CAR-T in multiple cancer indications (n = 15, cohorts w/ and w/o LDC), (B) gavocabtagene autoleucel (n = 7, w/ and w/o LDC) in multiple indications, (C) anti-glypican 3 CAR-T in advanced hepatocellular carcinoma (n = 13, dose-range 0.7-5.18 billion) and (D) anti-PSMA/TGFβ CAR-T in prostate cancer (n = 10, w/ and w/o LDC)...Using model simulation, CAR-T cell expansion was found to be dependent on initial tumor burden and antigen positive tumor fraction. The developed PBPK-PD model could be leveraged as an effective tool in future to provide mechanistic understanding on CK-PD behavior of cell therapies targeting solid tumors.
Journal • IO biomarker
|
GPC3 (Glypican 3) • TGFB1 (Transforming Growth Factor Beta 1)
|
gavocabtagene autoleucel (TC-210)
1m
ZWI-ZW171-10: A Study of ZW171 in Participants With Advanced or Metastatic Mesothelin-expressing Cancers (clinicaltrials.gov)
P1, N=32, Terminated, Zymeworks BC Inc. | N=160 --> 32 | Trial completion date: Dec 2027 --> Oct 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2027 --> Sep 2025; Sponsor decision
Enrollment change • Trial completion date • Trial termination • Trial primary completion date
3ms
ZWI-ZW171-10: A Study of ZW171 in Participants With Advanced or Metastatic Mesothelin-expressing Cancers (clinicaltrials.gov)
P1, N=160, Active, not recruiting, Zymeworks BC Inc. | Recruiting --> Active, not recruiting
Enrollment closed
3ms
Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer (clinicaltrials.gov)
P1/2, N=57, Active, not recruiting, TCR2 Therapeutics | N=36 --> 57 | Trial primary completion date: Nov 2028 --> Nov 2024
Enrollment change • Trial primary completion date • IO biomarker
|
MSLN (Mesothelin)
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • cyclophosphamide • gavocabtagene autoleucel (TC-210) • fludarabine IV
4ms
A Phase I/II Study of HY05350 in Mesothelin(MSLN)-Positive Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=262, Not yet recruiting, Sichuan Huiyu Pharmaceutical Co., Ltd
New P1/2 trial
5ms
A Study of JNJ-79032421 Targeting Mesothelin for Advanced Stage Solid Tumors (clinicaltrials.gov)
P1, N=35, Completed, Janssen Research & Development, LLC | Active, not recruiting --> Completed | Trial completion date: Sep 2025 --> Jun 2025 | Trial primary completion date: Sep 2025 --> Jun 2025
Trial completion • Trial completion date • Trial primary completion date
6ms
A Study of JNJ-79032421 Targeting Mesothelin for Advanced Stage Solid Tumors (clinicaltrials.gov)
P1, N=36, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Mar 2028 --> Sep 2025 | Trial primary completion date: Feb 2026 --> Sep 2025
Trial completion date • Trial primary completion date
7ms
CT-95 in Advanced Cancers Associated With Mesothelin Expression (clinicaltrials.gov)
P1, N=70, Recruiting, Context Therapeutics Inc. | N=50 --> 70
Enrollment change
|
CT-95
7ms
A Study of JNJ-79032421 Targeting Mesothelin for Advanced Stage Solid Tumors (clinicaltrials.gov)
P1, N=36, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting | N=210 --> 36 | Trial primary completion date: Feb 2027 --> Feb 2026
Enrollment closed • Enrollment change • Trial primary completion date
8ms
Mesothelin-Specific T-Cells (FH-TCR-Tᴍsʟɴ) for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
P1, N=9, Terminated, Fred Hutchinson Cancer Center | Trial completion date: Sep 2025 --> Jan 2025 | Active, not recruiting --> Terminated; Study terminated due to end of funding.
Trial completion date • Trial termination
|
HLA-A (Major Histocompatibility Complex, Class I, A) • MSLN (Mesothelin)
|
cyclophosphamide • bendamustine • fludarabine IV • FH-TCR-Tᴍsʟɴ