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

NCT04649385 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: BGB-A317-15025-101CTR20212721
• Study Type: interventional
• Target: 157
• Locations: 5 countries
• Sites: 20

Brief 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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (7)

• Phase 1a: Number of participants with dose limiting toxicities (DLTs)

  Participants will be considered evaluable for DLTs if they 1) received ≥ 80% of each scheduled study treatment administration during the DLT assessment window and/or 2) experienced a DLT.

  Up to 3 Years

• Phase 1a: Number of Participants Experiencing Adverse Events (AEs)

  Up to 4 Years

• Phase 1a: Number of Participants Experiencing Serious Adverse Events (SAEs)

  Up to 4 years

• The maximum tolerated dose (MTD) of BGB-15025

  The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%

  Up to 3 Years

• Recommended Doses for Expansion (RDFE) of BGB-15025 monotherapy

  The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%

  Up to 3 years

• RDFE of BGB-15025 in combination with tislelizumab

  The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%

  Up to 3 years

• Phase 1b: Overall Response Rate (ORR) as assessed by the investigator

  Up to 2 years

Secondary Outcomes (18)

• Phase 1a: Overall Response Rate (ORR) as assessed by the investigator

  Up to 3 years

• Duration Of Response (DOR) as assessed by the investigator

  Up to 3 years

• Disease Control Rate (DCR) as assessed by the investigator

  Up to 3 years

• Phase 1a: Maximum observed plasma concentration (Cmax) of BGB-15025

  Predose up to 8 hours postdose

• Phase 1a: Minimum observed plasma concentration (Cmin) of BGB-15025

  Predose up to 8 hours postdose

Study Arms (2)

Phase 1a: Dose Escalation

EXPERIMENTAL

Part A: Participants will receive once daily of BGB-15025 monotherapy in sequential cohorts of approximately 7 increasing doses Part B: Participants will receive once daily of BGB-15025 in sequential cohorts plus 200mg tislelizumab on day 1 of each 21-day cycle (combination therapy )

Drug: BGB-15025; Drug: Tislelizumab

Phase 1b: Dose Expansion

EXPERIMENTAL

Phase 1b dose expansion will begin based upon the recommended doses for expansion (RDFE) for BGB-15025 alone or in combination with tislelizumab, and with or without chemotherapy as determined from Phase 1a

Drug: BGB-15025; Drug: Tislelizumab

Interventions

BGB-15025 DRUG

Administered orally once or twice daily (QD or BID)

Phase 1a: Dose Escalation; Phase 1b: Dose Expansion

Tislelizumab DRUG

Administered 200 mg intravenous (IV) infusion

Also known as: BGB-A317

Phase 1a: Dose Escalation; 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:

• Phase 1a (dose escalation): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available, not tolerated or refused, and who have not received prior therapy targeting HPK1
• Phase 1b (dose expansion): Participant with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors, including non-small cell lung cancer, esophageal cancer or gastric/Gastroesophageal junction cancer (other solid tumors may be included) who have progressed following systemic anticancer therapies or have no prior systemic treatment for advanced disease
• At least 1 measurable lesion as defined per RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
• Adequate organ function as indicated by the following laboratory values up to first dose of study treatment: Hemoglobin≥ 90 g/L, Absolute neutrophil count ≥ 1.5 x 109/L , Serum total bilirubin ≤ 1.5 x ULN (\< 3 x ULN for participants with Gilbert syndrome ), AST and ALT≤ 2.5 x ULN

You may not qualify if:

• Active leptomeningeal disease or uncontrolled and untreated brain metastasis.
• Active autoimmune diseases or history of autoimmune diseases that may relapse
• Any active malignancy ≤ 2 years before the first dose of study treatment except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent
• Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study treatment
• History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including but not limited to pulmonary fibrosis, acute lung diseases, etc.

Sponsors & Collaborators

• BeiGene: lead

Study Sites (20)

Icahn School of Medicine At Mount Sinai

New York, New York, 10029-6504, United States

Location

The University of Texas Md Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Ut Health San Antonio Mays Cancer Center

San Antonio, Texas, 78229-4427, United States

Location

Prince of Wales Hospital

Randwick, New South Wales, NSW 2031, Australia

Location

Ashford Cancer Centre Research Northeast

Windsor Gardens, South Australia, SA 5087, Australia

Location

Peter Maccallum Cancer Centre

Melbourne, Victoria, VIC 3000, Australia

Location

Linear Clinical Research

Nedlands, Western Australia, WA 6009, Australia

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, 06351, South Korea

Location

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi, 06591, South Korea

Location

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea

Location

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, 05505, South Korea

Location

MeSH Terms

Interventions

tislelizumab

Study Design

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

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 2, 2020
• Study Start: March 4, 2021
• Primary Completion: October 17, 2025
• Study Completion (Estimated): May 16, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (3); KR (5); CN (7); NZ (1); AU (4)