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    DRUG CLASS:

    MALT1 protein inhibitor

    Related drugs:
    12d
    ONO-7018-01: A Study to Investigate the Safety, Tolerability, PK, PD, and Efficacy of ONO-7018 in Patients With R/R NHL or CLL (clinicaltrials.gov)
    P1, N=9, Terminated, Ono Pharmaceutical Co., Ltd. | N=108 --> 9 | Trial completion date: Dec 2027 --> Aug 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2027 --> Aug 2025; The study was terminated due to a strategic decision to discontinue development.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • First-in-human
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    MALT1 (MALT1 Paracaspase)
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    CTX-177
    1m
    Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets (clinicaltrials.gov)
    P1, N=78, Active, not recruiting, AbbVie | Recruiting --> Active, not recruiting | N=150 --> 78
    Enrollment closed • Enrollment change • Adverse events • First-in-human
    1m
    Dose Determining Study of EXS73565 in Participants With Relapsed or Refractory B-Cell Malignancies (clinicaltrials.gov)
    P1, N=50, Recruiting, Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc. | N=31 --> 50
    Enrollment change • Trial initiation date
    1m
    Dose Determining Study of EXS73565 in Participants With Relapsed or Refractory B-Cell Malignancies (clinicaltrials.gov)
    P1, N=31, Recruiting, Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
    New P1 trial
    3ms
    Therapeutic targeting of MALT1 in oncology: Mechanism, inhibitor development, and clinical prospects. (PubMed, J Cell Commun Signal)
    Notably, agents such as safimaltib (JNJ-67856633) have shown manageable safety profiles and preliminary antitumor activity in early-phase trials for relapsed/refractory B-cell malignancies. However, MALT1-targeted therapy poses a dual challenge: although inhibiting oncogenic signaling and tumor cell proliferation, it also disrupts immunosuppressive Treg function, risking autoimmune toxicity by compromising the tumor microenvironment. This review systematically analyzes MALT1's oncogenic roles across cancers, clarifies inhibitor mechanisms, and evaluates translational challenges and strategic opportunities for precision oncology and combination immunotherapy.
    Review • Journal
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    MALT1 (MALT1 Paracaspase)
    |
    safimaltib (JNJ-6633)
    4ms
    SGR-1505-101: Study of SGR-1505 in Mature B-Cell Neoplasms (clinicaltrials.gov)
    P1, N=98, Recruiting, Schrödinger, Inc. | N=52 --> 98 | Trial completion date: Mar 2026 --> Nov 2027 | Trial primary completion date: Mar 2026 --> Nov 2027
    Enrollment change • Trial completion date • Trial primary completion date
    |
    BCL2 (B-cell CLL/lymphoma 2)
    |
    SGR-1505
    5ms
    A Phase 1 Dose-Escalation, Food Effect, and Drug-Drug Interaction Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the MALT1 Inhibitor, SGR-1505, in Healthy Volunteers. (PubMed, Clin Pharmacol Drug Dev)
    Co-administration with posaconazole increased SGR-1505 exposure 3-fold...Asymptomatic, reversible indirect hyperbilirubinemia occurred, consistent with inhibition of UGT1A1. SGR-1505 was well-tolerated and exhibited favorable pharmacokinetic and pharmacodynamic properties, supporting further clinical development.
    P1 data • PK/PD data • Journal
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    IL2 (Interleukin 2) • MALT1 (MALT1 Paracaspase)
    |
    Noxafil (posaconazole) • SGR-1505
    8ms
    Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets (clinicaltrials.gov)
    P1, N=150, Recruiting, AbbVie | Trial completion date: Jun 2027 --> Jul 2029 | Trial primary completion date: Jun 2027 --> Jul 2029
    Trial completion date • Trial primary completion date • Adverse events • First-in-human
    8ms
    Accelerated In Silico Discovery of SGR-1505: A Potent MALT1 Allosteric Inhibitor for the Treatment of Mature B-Cell Malignancies. (PubMed, J Med Chem)
    Multiparameter optimization allowed efficient prioritization of molecules with good potency and drug-like properties during lead optimization, which led to the discovery of a highly potent MALT1 inhibitor, SGR-1505, with a well-balanced property profile. It demonstrated strong antitumor activity alone and in combination with BTK inhibitor in multiple in vivo B-cell lymphoma xenograft models and progressed to a phase 1 clinical trial in patients with mature B-cell neoplasms.
    Journal
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    CARD11 (Caspase Recruitment Domain Family Member 11) • MALT1 (MALT1 Paracaspase)
    |
    SGR-1505
    10ms
    ADITI-1: Study Evaluating Safety Pharmacokinetics and Pharmacodynamics of AUR112 in Patients With Relapsed Advanced Lymphoma (clinicaltrials.gov)
    P1, N=40, Recruiting, Aurigene Discovery Technologies Limited | Not yet recruiting --> Recruiting
    Enrollment open
    11ms
    Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets (clinicaltrials.gov)
    P1, N=150, Recruiting, AbbVie | N=100 --> 150
    Enrollment change • Adverse events
    12ms
    A Study of JNJ-67856633 in Participants With Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov)
    P1, N=226, Completed, Janssen Research & Development, LLC | Active, not recruiting --> Completed
    Trial completion
    |
    safimaltib (JNJ-6633)