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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

Recruiting4

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

2026/08/11

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

China Medical University Hospital

Co-Principal Investigator

Chang-Fang Chiu 無
Cheng-Yuan Peng 無

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

第1期：針對 HCC 第一線治療的參與者，評估 pumitamig 併用 ipilimumab 的安全性和耐受性，並確認第 2 期建議劑量 (RP2D)。第2期：針對 HCC 第一線治療的參與者，評估 pumitamig 併用 ipilimumab，相較於 atezolizumab + bevacizumab 、和比較 pumitamig 作為單一療法的 OR。

Test Drug

輸注液

Active Ingredient

Pumitamig/PM8002/BNT327

Dosage Form

27C

Dosage

20 mg/mL 或50 mg/mL

Endpoints

第1期：不良事件 (AE)、嚴重不良事件 (SAE)（依據 CTCAE 第 5 版）、符合計畫書定義劑量限制毒性 (DLT) 條件的 AE、導致中止和死亡的 AE，以上所有事件的發生率。
第2期：由試驗主持人依據 RECIST 第 1.1 版進行評估的 OR（經確認完全緩解 (CR) 或部分緩解 (PR)）。

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