BGB-A3055 Alone and in Combination With Tislelizumab in Participants With Solid Tumors

NCT ID: NCT05935098

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 263 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-21
• Study Completion Date: 2027-03-31

Brief Summary

This study aims to evaluate how safe and well-tolerated the treatment is, how the body processes it, how it works on the tumors, and whether it shows early signs of fighting cancer in people with certain advanced or metastatic solid tumors.

Key details of the study include:

• The study is expected to last about 36 months.
• Participants will receive treatment until they either no longer benefit from the treatment, experience side effects that are too severe, or choose to stop participating.

Conditions

Advanced Solid Tumor; Metastatic Solid Tumor; Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1a Part A: Dose Escalation (BGB-A3055 Monotherapy)

Different groups of participants will receive increasing doses of BGB-A3055 alone to determine the most appropriate dosage levels.

Group Type: EXPERIMENTAL

BGB-A3055

Intervention Type: DRUG

Administered intravenously

Phase 1a Part B: Dose Escalation (BGB-A3055 + tislelizumab)

Different groups of participants will receive increasing doses of BGB-A3055 in combination with tislelizumab to determine the most appropriate dosage levels.

Group Type: EXPERIMENTAL

BGB-A3055

Intervention Type: DRUG

Administered intravenously

Tislelizumab

Intervention Type: DRUG

Administered intravenously

Phase 1b (Dose Expansion):

Participants will receive the recommended dose for expansion (RDFE) of BGB-A3055 in combination with tislelizumab with or without chemotherapy to provide additional information on the safety, tolerability, and potential benefits of the recommended dose.

Group Type: EXPERIMENTAL

BGB-A3055

Intervention Type: DRUG

Administered intravenously

Tislelizumab

Intervention Type: DRUG

Administered intravenously

Chemotherapy

Intervention Type: DRUG

Administered in accordance with relevant local guidelines and/or prescribing information.

Interventions

BGB-A3055

Administered intravenously

Intervention Type: DRUG

Tislelizumab

Administered intravenously

Intervention Type: DRUG

Chemotherapy

Administered in accordance with relevant local guidelines and/or prescribing information.

Intervention Type: DRUG

Other Intervention Names

BGB-A317

Eligibility Criteria

Inclusion Criteria

1. Age≥18 years on the day of signing the informed consent form (ICF) (or the legal age of consent in the jurisdiction in which the study is taking place, whichever is older).

2. All participants are also required to demonstrate an ECOG Performance Status score of ≤1 within 3 days before the first dose of study drug(s) and have adequate organ function.

3. Participants with histologically confirmed advanced or metastatic solid tumors associated with high CCR8 and who have previously received adequate available standard systemic therapy or for whom treatment is not available or not tolerated and who have not received any prior therapy targeting CCR8.

4. >=1 Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

5. Participants should be able to provide archival tumor tissue samples (as block or unstained slides) or fresh biopsy if there is no archival tissue at baseline. For selected cohorts, participants should be willing to provide post-treatment fresh biopsy at specified timepoints.

6. Females of childbearing potential and nonsterile males must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 120 days after the last dose of BGB-A3055 or tislelizumab (whichever is later), or up to 9 months after the last dose of chemotherapy, whichever is later. Females of childbearing potential must also have a negative urine or serum pregnancy test result ≤ 7 days before the first dose of study drug(s).

Exclusion Criteria

1. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.

2. Active autoimmune diseases or history of autoimmune diseases that may relapse

3. Any malignancy ≤ 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).

4. Participants with hepatitis B infection with HBV DNA ≥ 500 IU/mL (or ≥ 2500 copies/mL). Participants with active hepatitis C, and participants with HIV infection.

Note: Participants with chronic hepatitis B infection or resolved hepatitis B infection (HBV DNA < 500 IU/mL or < 2500 copies/mL) and considered stable are eligible. Participants with a negative HCV antibody test result at screening or a positive HCV antibody test result followed by a negative HCV RNA test result at screening are eligible to participate. Participants with treated HIV infection may be included if certain criteria are met.

5. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, or acute lung diseases.

6. Grade 3 immune-mediated adverse events on prior immune-oncology agent.

7. Cardiovascular risk factors, including but not limited to pulmonary embolism ≤ 28 days or history of acute myocardial infarction or heart failure ≤ 6 months before the first dose of study drug(s).

8. Uncontrolled diabetes.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BeiGene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

BeiGene

Locations

Advent Health Cancer Institute

Orlando, Florida, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

John Theurer Cancer Center Hackensack University Medical Center

Hackensack, New Jersey, United States

The University of Texas Md Anderson Cancer Center

Houston, Texas, United States

Next Dallas

Irving, Texas, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Chris Obrien Lifehouse

Camperdown, New South Wales, Australia

Icon Cancer Centre South Brisbane

South Brisbane, Queensland, Australia

Linear Clinical Research

Nedlands, Western Australia, Australia

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, China

Rui Jin Hospital Shanghai Jiao Tong University School of Medicinejiading Branch

Shanghai, Shanghai Municipality, China

Changzhi Peoples Hospital

Changzhi, Shanxi, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Centre de Lutte Contre Le Cancer Institut Bergonie

Bordeaux, , France

Institut Curie

Paris, , France

Ico Site Rene Gauducheau

SaintHerblain, , France

Seoul National University Bundang Hospital

BundangGu SeongnamSi, Gyeonggi-do, South Korea

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, South Korea

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, South Korea

Countries

United States; Australia; China; France; South Korea

Other Identifiers

2023-505322-34-00

Identifier Type: CTIS

Identifier Source: secondary_id

CTR20241681

Identifier Type: OTHER

Identifier Source: secondary_id

BGB-A317-A3055-101

Identifier Type: -

Identifier Source: org_study_id