PM8002 (BNT327) Clinical Trials

18 recruiting trials·BioNTech (acquired Biotheus 2024)

PM8002 (BNT327) is a humanized bispecific antibody targeting PD-L1 and VEGF-A, distinct from PD-1–targeting agents in its checkpoint specificity while sharing the dual immunotherapy-plus-anti-angiogenic rationale. BioNTech acquired Biotheus for $800 million in 2024, securing global rights to PM8002 as a cornerstone of its solid tumor pipeline. Phase 2 data in treatment-naive NSCLC showed an objective response rate of approximately 47% with manageable toxicity. Active trials span NSCLC, small-cell lung cancer, triple-negative breast cancer, cervical cancer, and ovarian cancer; eligibility typically requires PD-L1 expression testing and may specify prior platinum exposure or histology.

Check eligibility by cancer type

Lung Cancer — Non-Small Cell (NSCLC)Lung Cancer — Small Cell (SCLC)Triple-Negative Breast Cancer (TNBC)

Top recruiting

Recruiting PM8002 trials

Ranked by phase and US site count.

Phase 2/Phase 346 US sites

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

Bristol-Myers Squibb

Phase 2/Phase 333 US sites

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)

Bristol-Myers Squibb

Phase 330 US sites

Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer

BioNTech SE

Phase 2/Phase 326 US sites

Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer

BioNTech SE

Phase 315 US sites

ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer

BioNTech SE

Phase 3

PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC

Biotheus Inc.

Additional trials

More PM8002 trials

Phase 2

NCT06892548A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung CancerPhase 1/Phase 215 US sites NCT07070232A 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 TumorsPhase 1/Phase 215 US sites NCT06953089DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid TumorsPhase 215 US sites NCT06618287A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid TumorsPhase 1/Phase 213 US sites NCT06827236A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast CancerPhase 1/Phase 29 US sites NCT06841055Safety 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 TreatmentPhase 25 US sites NCT07079631A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment BNT327 and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal CancerPhase 1/Phase 24 US sites NCT07111520A 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)Phase 1/Phase 21 US site

4 international trials (no US sites)

NCT07297212A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent GlioblastomaPhase 2 NCT05879055A Study of PM8002 in Combination With Chemotherapy in Patients With NENPhase 2 NCT07255404A 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 CancerPhase 2 NCT05918445PM8002 in the Treatment of Patients With Advanced Solid TumorsPhase 1/Phase 2

Cancer types studied

Lung Cancer — Non-Small Cell (NSCLC)Lung Cancer — Small Cell (SCLC)Triple-Negative Breast Cancer (TNBC)

Key biomarker pages

PD-L1 (CD274) Lung Cancer — Non-Small Cell (NSCLC)PD-L1 (CD274) Lung Cancer — Small Cell (SCLC)PD-L1 (CD274) Triple-Negative Breast Cancer (TNBC)PD-L1 (CD274) Cervical Cancer

How OncoMatch helps you find PM8002 trials

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Lung Cancer — Non-Small Cell (NSCLC) trials →Lung Cancer — Small Cell (SCLC) trials →Triple-Negative Breast Cancer (TNBC) trials →