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 · tracked via the Priya Life Science UK tracker

Sponsor

Bristol-Myers Squibb

Phase

Phase 1/Phase 2

Started

2026-03-16

Last updated

2026-09-14

Condition(s) studied

Hepatocellular Carcinoma (HCC)

Investigational drug(s) / intervention(s)

PumitamigIpilimumab

Pumitamig: Specified dose on specified days

Ipilimumab: Specified dose on specified days

Study summary

The purpose of this study is 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)

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria * Participants must have a histologically confirmed diagnosis of locally advanced or unresectable Hepatocellular Carcinoma (HCC). * Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Participants must have no prior systemic therapy for advanced/ unresectable HCC. * Participants must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Exclusion Criteria * Participants must not have significant bleeding or coagulation disorders or other obvious bleeding risk evidence. * Participants must not have an organ transplant or autoimmune disease. * Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

Number of participants with adverse events (AEs) — Up to approximately 25 weeks
Phase 1
Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5)) — Up to approximately 25 weeks
Phase 1
Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria — Up to day 21
Phase 1
Number of participants with AEs leading to discontinuation — Up to approximately 25 weeks
Phase 1
Number of participants with AEs leading to death — Up to approximately 25 weeks
Phase 1
Objective response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment — Up to week 48
Phase 2

Trial sites (67)

Facility	City	Region	Status
Local Institution - 0137	Duarte	California	Not Yet Recruiting
Local Institution - 0070	Los Angeles	California	Not Yet Recruiting
Local Institution - 0107	Chicago	Illinois	Not Yet Recruiting
Local Institution - 0134	Detroit	Michigan	Not Yet Recruiting
John Theurer Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey	Recruiting
Local Institution - 0100	Mineola	New York	Not Yet Recruiting
Providence Portland Medical Center	Portland	Oregon	Recruiting
Providence St. Vincent Medical Center	Portland	Oregon	Recruiting
Tennessee Oncology	Nashville	Tennessee	Recruiting
Vanderbilt University Medical Center	Nashville	Tennessee	Recruiting
Local Institution - 0083	Seattle	Washington	Not Yet Recruiting
Royal Prince Alfred Hospital	Camperdown	New South Wales	Recruiting
Local Institution - 0033	Westmead	New South Wales	Not Yet Recruiting
Sunshine Coast University Hospital	Birtinya	Queensland	Recruiting
The Royal Melbourne Hospital	Parkville	Victoria	Recruiting
Bradfordhill	Santiago	Santiago Metropolitan	Recruiting
Pontifica Universidad Catolica De Chile	Santiago Region Metropolitana	Santiago Metropolitan	Recruiting
Local Institution - 0122	Hefei	Anhui	Not Yet Recruiting
Local Institution - 0114	Beijing	Beijing Municipality	Not Yet Recruiting
Local Institution - 0125	Chongqing	Chongqing Municipality	Not Yet Recruiting
Local Institution - 0116	Fuzhou	Fujian	Not Yet Recruiting
Local Institution - 0075	Guangzhou	Guangdong	Not Yet Recruiting
Local Institution - 0129	Nanning	Guangxi	Not Yet Recruiting
Local Institution - 0130	Harbin	Heilongjiang	Not Yet Recruiting
Local Institution - 0128	Nanyang	Henan	Not Yet Recruiting
Local Institution - 0119	Nanjing	Jiangsu	Not Yet Recruiting
Local Institution - 0123	Nanchang	Jiangxi	Not Yet Recruiting
Local Institution - 0115	Xi'an	Shaanxi	Withdrawn
Local Institution - 0086	Xi'an	Shaanxi	Not Yet Recruiting
Local Institution - 0118	Jinan	Shandong	Not Yet Recruiting
Local Institution - 0078	Shanghai	Shanghai Municipality	Not Yet Recruiting
Local Institution - 0138	Chengdu	Sichuan	Not Yet Recruiting
Local Institution - 0126	Hangzhou	Zhejiang	Not Yet Recruiting
CHU Bordeaux Haut-Leveque	Pessac	Aquitaine	Recruiting
Centre Hospitalier Universitaire de Grenoble	La Tronche	Auvergne-Rhône-Alpes	Recruiting
Local Institution - 0001	Montpellier	Languedoc-Roussillon	Not Yet Recruiting
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord	Saint Priest En Jarez	Pays de la Loire Region	Recruiting
Local Institution - 0003	Bobigny	France	Not Yet Recruiting
Local Institution - 0031	Cologne	North Rhine-Westphalia	Not Yet Recruiting
Universitatsklinikum Schleswig-Holstein	Lübeck	Schleswig-Holstein	Recruiting

+ 27 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07291076 on ClinicalTrials.gov ↗ ← All trials in the UK