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    DRUG CLASS:

    PGE4 antagonist

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    Trials
    4d
    A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer (clinicaltrials.gov)
    P2, N=144, Recruiting, Ono Pharmaceutical Co. Ltd | Not yet recruiting --> Recruiting | Initiation date: Jul 2025 --> Nov 2025
    Enrollment open • Trial initiation date • MSI-H • dMMR
    |
    Opdivo (nivolumab) • Avastin (bevacizumab) • 5-fluorouracil • oxaliplatin • leucovorin calcium • BMS-986310
    2ms
    Vorbipiprant (CR6086) / Balstilimab (AGEN2034) Combination in Stage IV Refractory pMMR - MSS CRC, and Other Metastatic GI Cancers (clinicaltrials.gov)
    P1/2, N=107, Active, not recruiting, Rottapharm Biotech | Recruiting --> Active, not recruiting
    Enrollment closed • Mismatch repair • pMMR
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF wild-type • RAS mutation
    |
    balstilimab (AGEN2034) • vorbipiprant (CR6086)
    2ms
    Pilot Window of Opportunity Trial (POET) (clinicaltrials.gov)
    P2, N=10, Recruiting, University of Oklahoma | Trial primary completion date: Sep 2025 --> Dec 2025
    Trial primary completion date
    |
    TPST-1495
    3ms
    TPST-1495-001: Phase 1a/1b Study of TPST-1495 as a Single Agent and in Combination With Pembrolizumab in Subjects With Solid Tumors (clinicaltrials.gov)
    P1, N=89, Completed, Tempest Therapeutics | Active, not recruiting --> Completed | N=175 --> 89
    Trial completion • Enrollment change
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    PIK3CA mutation
    |
    Keytruda (pembrolizumab) • TPST-1495
    4ms
    EPRAD: DT-9081 Study in Participants With Advanced, Recurrent or Metastatic Solid Tumours (clinicaltrials.gov)
    P1, N=29, Completed, Domain Therapeutics SA | Active, not recruiting --> Completed | N=48 --> 29
    Trial completion • Enrollment change
    5ms
    Pilot Window of Opportunity Trial (POET) (clinicaltrials.gov)
    P2, N=10, Recruiting, University of Oklahoma | Trial completion date: Apr 2026 --> Sep 2026 | Trial primary completion date: Apr 2025 --> Sep 2025
    Trial completion date • Trial primary completion date
    |
    TPST-1495
    6ms
    ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer (clinicaltrials.gov)
    P1, N=46, Active, not recruiting, Ono Pharmaceutical Co. Ltd | Trial completion date: Jul 2025 --> Apr 2026 | Trial primary completion date: Jul 2025 --> Apr 2026
    Trial completion date • Trial primary completion date
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • letrozole • BMS-986310
    6ms
    Double/Triple Combinations of AN2025, AN0025 and Atezolizumab in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=47, Completed, Adlai Nortye Biopharma Co., Ltd. | Active, not recruiting --> Completed
    Trial completion
    |
    Tecentriq (atezolizumab) • buparlisib (AN2025) • palupiprant (AN0025)
    6ms
    HTL0039732 in Participants With Advanced Solid Tumours (clinicaltrials.gov)
    P1/2, N=150, Recruiting, Cancer Research UK | Trial primary completion date: Sep 2026 --> Jun 2027 | Trial completion date: Sep 2026 --> Jun 2027
    Trial completion date • Trial primary completion date
    |
    Tecentriq (atezolizumab) • NXE0039732
    7ms
    Study of ONO-4578 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=183, Active, not recruiting, Ono Pharmaceutical Co. Ltd | Trial completion date: Jan 2026 --> Mar 2027 | Trial primary completion date: Jan 2026 --> Mar 2027
    Trial completion date • Trial primary completion date
    |
    Opdivo (nivolumab) • BMS-986310
    7ms
    Vorbipiprant (CR6086) / Balstilimab (AGEN2034) Combination in Stage IV Refractory pMMR - MSS CRC, and Other Metastatic GI Cancers (clinicaltrials.gov)
    P1/2, N=107, Recruiting, Rottapharm Biotech | N=55 --> 107 | Trial completion date: Sep 2026 --> Jun 2027 | Trial primary completion date: Mar 2025 --> Dec 2026
    Enrollment change • Trial completion date • Trial primary completion date • Mismatch repair • pMMR
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF wild-type • RAS mutation
    |
    balstilimab (AGEN2034) • vorbipiprant (CR6086)
    8ms
    A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer (clinicaltrials.gov)
    P2, N=144, Not yet recruiting, Ono Pharmaceutical Co. Ltd
    New P2 trial
    |
    Opdivo (nivolumab) • Avastin (bevacizumab) • 5-fluorouracil • oxaliplatin • leucovorin calcium • BMS-986310