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    DRUG:

    zalifrelimab (UGN-301)

    i
    Other names: UGN301, RebmAb 600, UGN 301, UGN-301, AGEN-1884, AGEN1884, RebmAb-600, AGEN 1884, RebmAb600
    Company:
    Agenus, Betta Pharma, Recepta
    Drug class:
    CTLA4 antagonist
    Related drugs:
    1d
    RaPiDS- A Phase 2 Study of Anti-PD-1 Independently or in Combination With Anti-CTLA-4 in Second-Line Cervical Cancer (clinicaltrials.gov)
    P2, N=211, Terminated, Agenus Inc. | Active, not recruiting --> Terminated; Sponsor strategic decision
    Trial termination
    |
    balstilimab (AGEN2034) • zalifrelimab (UGN-301)
    12d
    rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG (clinicaltrials.gov)
    P1, N=36, Recruiting, Ann & Robert H Lurie Children's Hospital of Chicago | Trial completion date: Dec 2025 --> Sep 2027 | Trial primary completion date: Jun 2025 --> Sep 2026
    Trial completion date • Trial primary completion date • Checkpoint inhibition • First-in-human
    |
    balstilimab (AGEN2034) • zalifrelimab (UGN-301)
    2ms
    Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas (clinicaltrials.gov)
    P2, N=65, Recruiting, University of Colorado, Denver | Trial completion date: Nov 2026 --> Dec 2027 | Trial primary completion date: Nov 2025 --> Apr 2027
    Trial completion date • Trial primary completion date • Checkpoint inhibition
    |
    pegylated liposomal doxorubicin • balstilimab (AGEN2034) • botensilimab (AGEN1181) • zalifrelimab (UGN-301)
    2ms
    A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC) (clinicaltrials.gov)
    P1, N=51, Completed, UroGen Pharma Ltd. | Active, not recruiting --> Completed
    Trial completion
    |
    gemcitabine • zalifrelimab (UGN-301) • Vesimune (imiquimod intravesical)
    11ms
    Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas (clinicaltrials.gov)
    P2, N=65, Recruiting, University of Colorado, Denver | N=28 --> 65
    Enrollment change • Checkpoint inhibition
    |
    pegylated liposomal doxorubicin • balstilimab (AGEN2034) • botensilimab (AGEN1181) • zalifrelimab (UGN-301)
    1year
    RaPiDS- A Phase 2 Study of Anti-PD-1 Independently or in Combination With Anti-CTLA-4 in Second-Line Cervical Cancer (clinicaltrials.gov)
    P2, N=212, Active, not recruiting, Agenus Inc. | Trial primary completion date: Jan 2025 --> Aug 2025
    Trial primary completion date
    |
    balstilimab (AGEN2034) • zalifrelimab (UGN-301)
    1year
    A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC) (clinicaltrials.gov)
    P1, N=51, Active, not recruiting, UroGen Pharma Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    gemcitabine • zalifrelimab (UGN-301) • Vesimune (imiquimod intravesical)
    1year
    A Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab (clinicaltrials.gov)
    P1/2, N=71, Recruiting, ImmunoGenesis
    New P1/2 trial
    |
    balstilimab (AGEN2034) • zalifrelimab (UGN-301) • evofosfamide (IMGS-101)
    1year
    NUMANTIA: Study to Evaluate the Safety and Efficacy of Treatment With NLM-001 and Standard Chemotherapy Plus Zalifrelimab in Patients With Advanced Pancreatic Cancer (clinicaltrials.gov)
    P1/2, N=28, Active, not recruiting, Nelum Corp | Trial completion date: Oct 2024 --> Apr 2025 | Trial primary completion date: Oct 2024 --> Apr 2025
    Trial completion date • Trial primary completion date
    |
    gemcitabine • albumin-bound paclitaxel • zalifrelimab (UGN-301) • NLM-001
    1year
    NUMANTIA: Study to Evaluate the Safety and Efficacy of Treatment With NLM-001 and Standard Chemotherapy Plus Zalifrelimab in Patients With Advanced Pancreatic Cancer (clinicaltrials.gov)
    P1/2, N=28, Active, not recruiting, Nelum Corp | Trial completion date: Oct 2024 --> Apr 2025 | Trial primary completion date: Oct 2024 --> Apr 2025
    Trial completion date • Trial primary completion date
    |
    gemcitabine • albumin-bound paclitaxel • zalifrelimab (UGN-301) • NLM-001
    over1year
    RaPiDS- A Phase 2 Study of Anti-PD-1 Independently or in Combination With Anti-CTLA-4 in Second-Line Cervical Cancer (clinicaltrials.gov)
    P2, N=212, Active, not recruiting, Agenus Inc. | Trial primary completion date: Aug 2024 --> Jan 2025
    Trial primary completion date • Combination therapy
    |
    balstilimab (AGEN2034) • zalifrelimab (UGN-301)
    over1year
    Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas (clinicaltrials.gov)
    P2, N=28, Recruiting, University of Colorado, Denver | Trial completion date: Nov 2025 --> Nov 2026 | Trial primary completion date: Nov 2024 --> Nov 2025
    Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition • Checkpoint block • Metastases
    |
    pegylated liposomal doxorubicin • balstilimab (AGEN2034) • botensilimab (AGEN1181) • zalifrelimab (UGN-301)