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    DRUG:

    BNT324

    i
    Other names: BNT324, DB-1311, BNT 324, DB 1311, BNT-324, DB1311
    Company:
    BioNTech, DualityBio
    Drug class:
    Topoisomerase I inhibitor, B7-H3-targeted antibody-drug conjugate
    Related drugs:
    7d
    DB-1311-201: DB-1311 in Combination with BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors (2025-523895-22-00)
    P1/2, N=102, Not yet recruiting, Dualitybio Inc. | N=57 --> 102
    Enrollment change
    |
    pumitamig (BNT327) • BNT324
    1m
    DB-1311-201: DB-1311 in Combination with BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors (2025-523895-22-00)
    P1/2, N=57, Not yet recruiting, Dualitybio Inc.
    New P1/2 trial
    |
    pumitamig (BNT327) • BNT324
    1m
    BNT324-03: A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov)
    P3, N=736, Recruiting, BioNTech SE | Not yet recruiting --> Recruiting
    Enrollment open
    |
    docetaxel • prednisone • BNT324
    3ms
    BNT324-01: A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer (clinicaltrials.gov)
    P1/2, N=594, Recruiting, BioNTech SE | N=112 --> 594
    Enrollment change
    |
    pumitamig (BNT327) • BNT324
    3ms
    BNT324-01: A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer (clinicaltrials.gov)
    P1/2, N=112, Recruiting, BioNTech SE | N=82 --> 112
    Enrollment change
    |
    pumitamig (BNT327) • BNT324
    3ms
    BNT324-01: A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer (clinicaltrials.gov)
    P1/2, N=82, Recruiting, BioNTech SE | N=52 --> 82
    Enrollment change
    |
    pumitamig (BNT327) • BNT324
    4ms
    BNT324-01: A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer (clinicaltrials.gov)
    P1/2, N=52, Recruiting, BioNTech SE | N=26 --> 52
    Enrollment change
    |
    pumitamig (BNT327) • BNT324
    4ms
    BNT324-01: A clinical study to investigate the efficacy and safety of an investigational combination therapy with BNT324 and BNT327 in patients with advanced lung cancer (2024-520238-31-01)
    P1/2, N=26, Not yet recruiting, BioNTech SE
    New P1/2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    pumitamig (BNT327) • BNT324
    5ms
    A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov)
    P3, N=736, Not yet recruiting, BioNTech SE
    New P3 trial
    |
    docetaxel • prednisone • BNT324
    7ms
    DB-1311-O-1001: A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=862, Recruiting, DualityBio Inc. | Trial completion date: Jan 2028 --> May 2028 | Trial primary completion date: Sep 2027 --> Dec 2027
    Trial completion date • Trial primary completion date • First-in-human
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • CD276 (CD276 Molecule)
    |
    BRAF V600E • KRAS mutation • EGFR mutation • KRAS G12C • BRAF V600 • ALK rearrangement • MET exon 14 mutation • ROS1 rearrangement • MET mutation • RET rearrangement • KRAS G12
    |
    enzalutamide • abiraterone acetate • itraconazole • BNT324 • ritonavir
    10ms
    DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P2, N=492, Recruiting, DualityBio Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    pumitamig (BNT327) • BNT324
    10ms
    DB-1311-O-1001: A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=750, Recruiting, DualityBio Inc. | Trial completion date: Sep 2026 --> Jan 2028 | Trial primary completion date: Sep 2026 --> Sep 2027
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • CD276 (CD276 Molecule)
    |
    BRAF V600E • KRAS mutation • EGFR mutation • KRAS G12C • BRAF V600 • ALK rearrangement • MET exon 14 mutation • ROS1 rearrangement • MET mutation • RET rearrangement • KRAS G12
    |
    itraconazole • BNT324 • ritonavir