Pumitamig
Sponsors
Bristol-Myers Squibb, BioNTech SE
Conditions
Advanced Renal Cell Carcinoma (RCC)Advanced Solid TumorBreast CancerBreast NeoplasmsExtensive-stage Small-cell Lung CancerHepatocellular Carcinoma (HCC)Lung CancerNon-Small Cell Lung Cancer (NSCLC)
Phase 1
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors
RecruitingNCT06618287
Start: 2025-02-04End: 2031-02-26Target: 416Updated: 2026-03-17
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
RecruitingNCT07070232
Start: 2025-08-12End: 2029-10-01Target: 980Updated: 2026-03-12
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)
RecruitingNCT07291076
Start: 2026-03-16End: 2031-10-14Target: 129Updated: 2026-03-27
A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208)
RecruitingNCT07293351
Start: 2026-04-30End: 2031-11-26Target: 234Updated: 2026-03-31
Phase 2
Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer
RecruitingNCT06712316
Start: 2025-01-07End: 2030-03-01Target: 1260Updated: 2026-03-17
Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy as First-line or Second-line Treatment
RecruitingNCT06841055
Start: 2025-03-03End: 2028-10-01Target: 60Updated: 2026-03-13
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)
RecruitingNCT07221149
Start: 2026-03-13End: 2032-09-11Target: 690Updated: 2026-04-02
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
RecruitingNCT07221357
Start: 2025-12-31End: 2034-03-11Target: 990Updated: 2026-03-31
A Clinical Trial Testing the Safety of BNT327 (an Investigational Drug) and How Well it Works When Combined With Chemotherapy for People Who Have Not Been Treated Yet for Pancreatic Cancer
RecruitingNCT07255404
Start: 2025-12-04End: 2028-08-31Target: 105Updated: 2026-01-09
A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma
RecruitingNCT07297212
Start: 2026-01-15End: 2029-07-01Target: 75Updated: 2026-03-12
A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Not yet recruitingNCT07492680
Start: 2026-07-17End: 2032-05-20Target: 260Updated: 2026-03-25
Phase 3
Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer
RecruitingNCT06712355
Start: 2025-02-03End: 2029-03-01Target: 621Updated: 2026-02-13
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
RecruitingNCT07173751
Start: 2025-10-30End: 2030-09-01Target: 558Updated: 2026-03-25
A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201)
RecruitingNCT07361497
Start: 2026-03-16End: 2033-12-31Target: 850Updated: 2026-03-27
A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202)
RecruitingNCT07361510
Start: 2026-03-12End: 2031-10-14Target: 750Updated: 2026-03-27