Maintained by Sreepriya Prasannan

MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 — Top 14 finalist

Compiled from ClinicalTrials.gov registry records · Last verified 25 Sep 2026 · Editorial standards

At a glance

Pumitamig is named as an intervention in 40 current clinical trials in our China, USA, UK, India and Ireland registers. 29 are recruiting patients now. The most common phase is Phase 1/2. The sponsor with the most trials is Bristol-Myers Squibb (13). The most-studied condition is Non-small Cell Lung Cancer.

Trials by status

Recruiting2973%
Not yet open13%
Active, closed1025%

Trials by phase

Phase 1/21538%
Phase 21333%
Phase 3718%
Phase 2/338%
Phase 125%

Clinical trials of Pumitamig

40 trials

Study	Phase	Status	Lead sponsor	Registers
An Open-label Study to Assess Safety and Efficacy of SZC in Paediatric Patients With Hyperkalaemia NCT03813407 · ClinicalTrials.gov ↗ · Hyperkalaemia	Phase 3	Recruiting	AstraZeneca	UK, USA, India, China
Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer NCT06712355 · ClinicalTrials.gov ↗ · Extensive-stage Small-cell Lung Cancer	Phase 3	Recruiting	BioNTech SE	UK, USA, China
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer NCT07173751 · Breast Neoplasms	Phase 3	Recruiting	BioNTech SE	UK, USA, China
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) NCT07361497 · ClinicalTrials.gov ↗ · Non-small Cell Lung Cancer (NSCLC)	Phase 3	Recruiting	Bristol-Myers Squibb	Ireland, UK, USA, India, China
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) NCT07361510 · ClinicalTrials.gov ↗ · Non-Small Cell Lung Cancer (NSCLC)	Phase 3	Recruiting	Bristol-Myers Squibb	UK, USA, India, China
Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer NCT06712316 · ClinicalTrials.gov ↗ · Non-small Cell Lung Cancer	Phase 2/3	Recruiting	BioNTech SE	UK, USA, China
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) NCT07221149 · Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma	Phase 2/3	Recruiting	Bristol-Myers Squibb	UK, USA, India, China
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 NCT07221357 · ClinicalTrials.gov ↗ · Untreated, Unresectable, or Metastatic Colorectal Cancer	Phase 2/3	Recruiting	Bristol-Myers Squibb	UK, USA, India, China
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 NCT06841055 · ClinicalTrials.gov ↗ · Non-small Cell Lung Cancer	Phase 2	Recruiting	BioNTech SE	UK, USA
DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors NCT06953089 · Solid Tumors	Phase 2	Recruiting	DualityBio Inc.	USA, China
PM8002 (BNT327) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer NCT07133750 · ClinicalTrials.gov ↗ · CRC (Colorectal Cancer)	Phase 2	Recruiting	Biotheus Inc.	China
A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma NCT07297212 · ClinicalTrials.gov ↗ · Recurrent Glioblastoma	Phase 2	Recruiting	BioNTech SE	China
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) NCT07492680 · ClinicalTrials.gov ↗ · Solid Tumors	Phase 2	Recruiting	Bristol-Myers Squibb	Ireland, USA, China
A Study To Assess the Safety, Tolerability, and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pumitamig and PDCT as First-line Treatment for Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) NCT07680764 · Locally Advanced Non-Small Cell Lung Cancer (NSCLC), Metastatic Non-Small Cell Lung Cancer (NSCLC)	Phase 2	Recruiting	Bristol-Myers Squibb	UK, USA, China
A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors NCT04895709 · ClinicalTrials.gov ↗ · Cervical Cancer, Gastric/Gastroesophageal Junction Adenocarcinoma, Microsatellite Stable Colorectal Cancer	Phase 1/2	Recruiting	Bristol-Myers Squibb	USA
PM8002 in the Treatment of Patients With Advanced Solid Tumors NCT05918445 · ClinicalTrials.gov ↗ · Malignant Neoplasm	Phase 1/2	Recruiting	Biotheus Inc.	China
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors NCT06618287 · ClinicalTrials.gov ↗ · Lung Cancer, Breast Cancer	Phase 1/2	Recruiting	Bristol-Myers Squibb	UK, USA
A 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 Cancer NCT06827236 · ClinicalTrials.gov ↗ · Locally Advanced Breast Cancer, Unresectable Breast Carcinoma, Metastatic Breast Cancer	Phase 1/2	Recruiting	BioNTech SE	UK, USA, China
A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer NCT06892548 · ClinicalTrials.gov ↗ · Advanced Lung Cancer	Phase 1/2	Recruiting	BioNTech SE	UK, USA, China
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 NCT07070232 · ClinicalTrials.gov ↗ · Advanced Solid Tumor	Phase 1/2	Recruiting	BioNTech SE	UK, USA, China
A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment Pumitamig (BNT327) and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal Cancer NCT07079631 · ClinicalTrials.gov ↗ · Metastatic Colorectal Cancer	Phase 1/2	Recruiting	BioNTech SE	UK, USA
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) NCT07111520 · ClinicalTrials.gov ↗ · Non-small Cell Lung Cancer	Phase 1/2	Recruiting	BioNTech SE	UK, USA, China
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 NCT07147348 · ClinicalTrials.gov ↗ · Advanced Solid Tumor	Phase 1/2	Recruiting	BioNTech SE	China
A Phase 1/2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid Tumors NCT07160725 · ClinicalTrials.gov ↗ · Solid Tumours	Phase 1/2	Recruiting	Bristol-Myers Squibb	USA, China
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) NCT07291076 · ClinicalTrials.gov ↗ · Hepatocellular Carcinoma (HCC)	Phase 1/2	Recruiting	Bristol-Myers Squibb	UK, USA, China
A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Other Agents in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208) NCT07293351 · ClinicalTrials.gov ↗ · Advanced Renal Cell Carcinoma (RCC)	Phase 1/2	Recruiting	Bristol-Myers Squibb	Ireland, UK, USA, China
A Study to Assess the Safety and Tolerability of BMS-986525 Alone and in Combination Therapy in Participants With Relapsed/Refractory Small Cell Lung Cancer NCT07325136 · ClinicalTrials.gov ↗ · Relapsed/Refractory Small Cell Lung Cancer	Phase 1/2	Recruiting	Bristol-Myers Squibb	USA, China
A Study to Test the Safety and Tolerability of SBO-154 in Patients With Advanced Solid Tumors. NCT07042100 · ClinicalTrials.gov ↗ · Advanced Solid Tumors	Phase 1	Recruiting	Sun Pharma Advanced Research Company Limited	USA, India
A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC) NCT07195682 · ClinicalTrials.gov ↗ · Renal Cell Carcinoma	Phase 1	Recruiting	Bristol-Myers Squibb	USA
Neoadjuvant Chemotherapy Combined With Bispecific Antibody Versus Monoclonal Antibody in Locally Advanced NSCLC NCT06837948 · ClinicalTrials.gov ↗ · Locally Advanced Non-Small Cell Lung Cancer	Phase 2	Not yet open	Shanghai Pulmonary Hospital, Shanghai, China	China
PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC NCT06419621 · ClinicalTrials.gov ↗ · Triple Negative Breast Cancer(TNBC)	Phase 3	Active, closed	Biotheus Inc.	China
PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer NCT06616532 · ClinicalTrials.gov ↗ · SCLC	Phase 3	Active, closed	Biotheus Inc.	China
A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With NSCLC NCT05756972 · ClinicalTrials.gov ↗ · NSCLC	Phase 2	Active, closed	Biotheus Inc.	China
A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC NCT05844150 · ClinicalTrials.gov ↗ · SCLC	Phase 2	Active, closed	Biotheus Inc.	China
A Study of PM8002 in Combination With Chemotherapy in Patients With NEN NCT05879055 · ClinicalTrials.gov ↗ · Neuroendocrine Neoplasm	Phase 2	Active, closed	Biotheus Inc.	China
A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC NCT05879068 · ClinicalTrials.gov ↗ · SCLC	Phase 2	Active, closed	Biotheus Inc.	China
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy NCT06449209 · ClinicalTrials.gov ↗ · Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer	Phase 2	Active, closed	BioNTech SE	UK, USA
Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy NCT06449222 · ClinicalTrials.gov ↗ · Locally Advanced Breast Cancer, Triple Negative Breast Cancer, Metastatic Triple Negative Breast Cancers	Phase 2	Active, closed	BioNTech SE	UK, USA
First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors NCT05438329 · Advanced Solid Tumor	Phase 1/2	Active, closed	DualityBio Inc.	USA, China
A Study of PM8002 Plus Nab-paclitaxel as First Line Therapy for TNBC NCT05918133 · ClinicalTrials.gov ↗ · TNBC	Phase 1/2	Active, closed	Biotheus Inc.	China

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

Conditions studied with Pumitamig

41 conditions

Non-small Cell Lung Cancer3 Advanced Solid Tumor3 SCLC3 Solid Tumors2Locally Advanced Breast Cancer2Extensive-stage Small-cell Lung Cancer2Advanced Renal Cell Carcinoma (RCC)1Non-small Cell Lung Cancer (NSCLC)1Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma1Breast Neoplasms1Locally Advanced Non-Small Cell Lung Cancer (NSCLC)1Metastatic Non-Small Cell Lung Cancer (NSCLC)1

All 41 conditions

Condition (as registered)	Trials
Non-small Cell Lung Cancer	3
Advanced Solid Tumor	3
SCLC	3
Solid Tumors	2
Locally Advanced Breast Cancer	2
Extensive-stage Small-cell Lung Cancer	2
Advanced Renal Cell Carcinoma (RCC)	1
Non-small Cell Lung Cancer (NSCLC)	1
Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma	1
Breast Neoplasms	1
Locally Advanced Non-Small Cell Lung Cancer (NSCLC)	1
Metastatic Non-Small Cell Lung Cancer (NSCLC)	1
Metastatic Colorectal Cancer	1
Hepatocellular Carcinoma (HCC)	1
Untreated, Unresectable, or Metastatic Colorectal Cancer	1
Unresectable Breast Carcinoma	1
Metastatic Breast Cancer	1
Lung Cancer	1
Breast Cancer	1
Non-Small Cell Lung Cancer (NSCLC)	1
Solid Tumours	1
Renal Cell Carcinoma	1
Cervical Cancer	1
Gastric/Gastroesophageal Junction Adenocarcinoma	1
Microsatellite Stable Colorectal Cancer	1
Non-Small-Cell Lung Cancer	1
Relapsed/Refractory Small Cell Lung Cancer	1
Recurrent Glioblastoma	1
Advanced Lung Cancer	1
Small-cell Lung Cancer	1
Triple Negative Breast Cancer	1
Metastatic Triple Negative Breast Cancers	1
Hyperkalaemia	1
Advanced Solid Tumors	1
CRC (Colorectal Cancer)	1
Malignant Neoplasm	1
Locally Advanced Non-Small Cell Lung Cancer	1
TNBC	1
Neuroendocrine Neoplasm	1
Triple Negative Breast Cancer(TNBC)	1
NSCLC	1

By country register

Register	Trials	Recruiting
Clinical trials in China	32	23
Clinical trials in USA	28	25
Clinical trials in UK	20	18
Clinical trials in India	6	6
Clinical trials in Ireland	3	3

A trial with sites in more than one country appears in each of those registers.

Related compounds

Questions about Pumitamig trials

How many clinical trials are testing Pumitamig?

40 current trials in our China, USA, UK, India and Ireland registers name Pumitamig (also registered as BNT327) as a drug or biological intervention, as of the registry sync on 25 September 2026. Completed and withdrawn studies are not counted.

Are Pumitamig trials recruiting patients?

Yes. 29 of the 40 trials are recruiting: 23 with sites in China, 25 with sites in USA, 18 with sites in UK, 6 with sites in India and 3 with sites in Ireland. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Pumitamig clinical trials?

Bristol-Myers Squibb (13), BioNTech SE (13), Biotheus Inc (9) and DualityBio Inc (2), among 7 lead sponsors in total. The number in brackets is how many trials each organisation leads.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Pumitamig works or whether it is effective, and it is not medical advice.

How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Pumitamig works or whether it is effective. Each trial links to its own record so you can check it yourself.

ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Pumitamig (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 25 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.

Pumitamig clinical trials