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Clinical Trials List

Protocol NumberCA2660006

NCT Number(ClinicalTrials.gov Identfier)NCT07291076

Not yet recruiting

2025-12-15 - 2028-06-29

Phase I/II

Recruiting3

ICD-10C22.0

Liver cell carcinoma

ICD-10C22.2

Hepatoblastoma

ICD-10C22.3

Angiosarcoma of liver

ICD-10C22.4

Other sarcomas of liver

ICD-10C22.7

Other specified carcinomas of liver

ICD-10C22.8

Malignant neoplasm of liver, primary, unspecified as to type

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9155.0

Malignant neoplasm of liver, primary

ROSETTA HCC-206: An Open-Label, Multi-Center, Randomized Phase 1/2 Study of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC)

Trial Applicant

BRISTOL-MYERS SQUIBB (TAIWAN) LTD.
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/04/08

Investigators and Locations

Principal Investigator Ann-Lii Cheng 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Hsiang Huang 無

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ting-Tsung Chang

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Hepatocellular Carcinoma (HCC)

Objectives

Phase 1: In participants receiving first-line treatment for HCC, evaluate the safety and tolerability of pumitamig in combination with ipilimumab and confirm the Phase 2 recommended dose (RP2D). Phase 2: In participants receiving first-line treatment for HCC, evaluate the OR of pumitamig in combination with ipilimumab compared to atezolizumab + bevacizumab, and compare pumitamig as monotherapy.

Test Drug

Infusion fluid

Active Ingredient

Pumitamig/PM8002/BNT327

Dosage Form

27C

Dosage

20 mg/mL 或50 mg/mL

Endpoints

Phase 1: Incidence of all adverse events (AEs), serious adverse events (SAEs) (according to CTCAE version 5), AEs meeting the dose-limiting toxicity (DLT) criteria defined in the protocol, AEs leading to discontinuation, and death.

Phase 2: OR (confirmed complete response (CR) or partial response (PR)) assessed by the trial administrator according to RECIST version 1.1.

Inclution Criteria

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

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.

The Estimated Number of Participants

Taiwan

24 participants
Global

129 participants