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ACTIVE NOT RECRUITING
NCT04649385
PHASE1

BGB-15025 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Participants With Advanced Solid Tumors

Sponsor: BeiGene

View on ClinicalTrials.gov

Summary

The primary objective of this study is to assess the safety and tolerability of BGB-15025 alone and in combination with tislelizumab; and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended Phase 2 doses (RP2D) of BGB-15025 alone and in combination with tislelizumab in participants with advanced solid tumors.

Official title: A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HPK1 Inhibitor BGB-15025 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

157

Start Date

2021-03-04

Completion Date

2026-05-16

Last Updated

2026-02-20

Healthy Volunteers

No

Interventions

DRUG

BGB-15025

Administered orally once or twice daily (QD or BID)

DRUG

Tislelizumab

Administered 200 mg intravenous (IV) infusion

Locations (20)

Icahn School of Medicine At Mount Sinai

New York, New York, United States

The University of Texas Md Anderson Cancer Center

Houston, Texas, United States

Ut Health San Antonio Mays Cancer Center

San Antonio, Texas, United States

Prince of Wales Hospital

Randwick, New South Wales, Australia

Ashford Cancer Centre Research Northeast

Windsor Gardens, South Australia, Australia

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia

Linear Clinical Research

Nedlands, Western Australia, Australia

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Auckland City Hospital

Auckland, New Zealand

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, South Korea

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi, South Korea

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, South Korea