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

NCT05935098 | Terminated Phase 1 FDA Drug

• 3 other identifiers: BGB-A317-A3055-1012023-505322-34-00CTR20241681
• Study Type: interventional
• Target: 99
• Locations: 5 countries
• Sites: 26

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

Keywords

BGB-A3055; Tislelizumab; Advanced solid tumors; Safety monitoring; Monoclonal antibody; Preliminary antitumor activity; Metastatic cancer; Metastatic Solid Tumor; PD1; CCR8

Outcome Measures

Primary Outcomes (4)

• Phase 1a: Number of participants with adverse events (AEs)

  Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 and the American Society for Transplantation and Cellular Therapy \[ASTCT\] consensus grading system for cytokine release syndrome \[CRS\]), and including findings from laboratory assessments, electrocardiograms (ECGs), and physical examinations, and that meet protocol-defined dose-limiting toxicity (DLT) criteria.

  Up to 2 Years

• Phase 1a: Maximum tolerated dose (MTD) or maximum administered dose (MAD) of BGB-A3055

  MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate of 30%. MAD is defined as the highest dose administered.

  Up to 2 Years

• Phase 1a: Recommended dose for expansion (RDFE) of BGB-A3055 alone or in combination with tislelizumab

  The RDFEs of BGB-A3055, alone or in combination with tislelizumab will be determined based on biological effectiveness taking preclinical and clinical data, including safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity, into consideration.

  Up to 2 Years

• Phase 1b (Dose Expansion): Objective Response Rate (ORR)

  ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

  Up to 2 Years

Secondary Outcomes (11)

• Phase 1a: ORR

  Up to 2 Years

• Time to Response (TTR)

  Up to 2 Years

• Duration of Response (DOR)

  Up to 2 Years

• Disease Control Rate (DCR)

  Up to 2 Years

• Clinical Benefit Rate (CBR)

  Up to 2 Years

Study Arms (3)

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

EXPERIMENTAL

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

Drug: BGB-A3055

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

EXPERIMENTAL

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

Drug: BGB-A3055; Drug: Tislelizumab

Phase 1b (Dose Expansion):

EXPERIMENTAL

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.

Drug: BGB-A3055; Drug: Tislelizumab; Drug: Chemotherapy

Interventions

BGB-A3055 DRUG

Administered intravenously

Phase 1a Part A: Dose Escalation (BGB-A3055 Monotherapy); Phase 1a Part B: Dose Escalation (BGB-A3055 + tislelizumab); Phase 1b (Dose Expansion):

Tislelizumab DRUG

Administered intravenously

Also known as: BGB-A317

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

Chemotherapy DRUG

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

Phase 1b (Dose Expansion):

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
• Active autoimmune diseases or history of autoimmune diseases that may relapse
• 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).
• 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.
• History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, or acute lung diseases.
• Grade 3 immune-mediated adverse events on prior immune-oncology agent.
• 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).
• Uncontrolled diabetes.

Sponsors & Collaborators

• BeiGene: lead

Study Sites (26)

Advent Health Cancer Institute

Orlando, Florida, 32804-4603, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242-1009, United States

Location

John Theurer Cancer Center Hackensack University Medical Center

Hackensack, New Jersey, 07601-2191, United States

Location

The University of Texas Md Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Next Dallas

Irving, Texas, 75039-2743, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-4433, United States

Location

Chris Obrien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

Icon Cancer Centre South Brisbane

South Brisbane, Queensland, 4101, Australia

Location

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

Location

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, 110042, China

Location

Rui Jin Hospital Shanghai Jiao Tong University School of Medicinejiading Branch

Shanghai, Shanghai Municipality, 201801, China

Location

Changzhi Peoples Hospital

Changzhi, Shanxi, 046099, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Centre de Lutte Contre Le Cancer Institut Bergonie

Bordeaux, 33000, France

Location

Institut Curie

Paris, 75005, France

Location

Ico Site Rene Gauducheau

SaintHerblain, 44805, France

Location

Seoul National University Bundang Hospital

BundangGu SeongnamSi, Gyeonggi-do, 13620, South Korea

Location

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, 06351, South Korea

Location

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea

Location

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, 05505, South Korea

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

tislelizumab; Drug Therapy

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Study Director

  BeiGene

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 7, 2023
• Study Start: August 21, 2023
• Primary Completion: January 27, 2026
• Study Completion: January 27, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

US (6); CN (9); KR (5); FR (3); AU (3)