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    DRUG:

    pumitamig (BNT327)

    i
    Other names: BNT327, BMS986545, PM8002, PM 8002, PM-8002, BNT 327, BNT-327, BMS-986545
    Company:
    BMS, BioNTech
    Drug class:
    PD-L1 inhibitor, VEGF-A inhibitor
    Related drugs:
    3d
    ROSETTA GI 204: A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (ROSETTA Gastric-204) (clinicaltrials.gov)
    P2/3, N=690, Recruiting, Bristol-Myers Squibb
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 negative
    |
    Opdivo (nivolumab) • 5-fluorouracil • pumitamig (BNT327)
    4d
    ROSETTA CRC-203: A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer (clinicaltrials.gov)
    P2/3, N=990, Recruiting, Bristol-Myers Squibb
    Trial initiation date
    |
    Avastin (bevacizumab) • 5-fluorouracil • irinotecan • leucovorin calcium • pumitamig (BNT327)
    4d
    BNT326-02: A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P1/2, N=420, Recruiting, BioNTech SE
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    KRAS mutation • BRAF mutation • EGFR L858R • EGFR exon 19 deletion • ALK rearrangement • PD-L1 negative • RET mutation • MET mutation • EGFR negative
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel • pumitamig (BNT327) • BNT326 • MK-3475 SC
    10d
    ROSETTA-LUNG-01: Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer (clinicaltrials.gov)
    P3, N=621, Recruiting, BioNTech SE | N=249 --> 621
    Enrollment change
    |
    cisplatin • Tecentriq (atezolizumab) • carboplatin • etoposide IV • pumitamig (BNT327)
    10d
    BNT326-01: A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors (clinicaltrials.gov)
    P1/2, N=980, Recruiting, BioNTech SE | N=329 --> 980
    Enrollment change • Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • EGFR mutation • HR positive • BRAF mutation • HER-2 negative • EGFR L858R • HER-2 expression • EGFR exon 19 deletion • ALK rearrangement • PD-L1 expression + HER-2 overexpression • HER-2 negative + HR negative
    |
    itraconazole • pumitamig (BNT327) • BNT326
    10d
    A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206) (clinicaltrials.gov)
    P1/2, N=129, Recruiting, Bristol-Myers Squibb | N=47 --> 129
    Enrollment change • Trial initiation date
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • Yervoy (ipilimumab) • pumitamig (BNT327)
    10d
    A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206) (clinicaltrials.gov)
    P1/2, N=47, Recruiting, Bristol-Myers Squibb
    New P1/2 trial
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • Yervoy (ipilimumab) • pumitamig (BNT327)
    13d
    CA2660006: A Phase 1/2 Study of Pumitamig alone or in Combination with Ipilimumab in First-Line HCC (2025-523602-33-00)
    P1/2, N=33, Not yet recruiting, Bristol-Myers Squibb Services Unlimited Company
    New P1/2 trial
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • Yervoy (ipilimumab) • pumitamig (BNT327)
    24d
    ROSETTA Lung-02: Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (clinicaltrials.gov)
    P2/3, N=1260, Recruiting, BioNTech SE | N=656 --> 1260
    Enrollment change
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel • pemetrexed • pumitamig (BNT327)
    27d
    BNT326-01: A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors (clinicaltrials.gov)
    P1/2, N=280, Recruiting, BioNTech SE
    New P1/2 trial
    |
    itraconazole • pumitamig (BNT327) • BNT326
    27d
    BNT326-01: A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors (clinicaltrials.gov)
    P1/2, N=280, Recruiting, BioNTech SE | N=172 --> 280
    Enrollment change
    |
    itraconazole • pumitamig (BNT327) • BNT326
    1m
    A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=375, Recruiting, BioNTech SE | Trial completion date: Mar 2028 --> Aug 2028
    Trial completion date • First-in-human
    |
    pumitamig (BNT327)