CompletedPhase 1

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

United States, Australia, China157 participantsStarted 2021-03-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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, and metastatic including non-small cell lung cancer, and gastric/Gastroesophageal junction cancer that have no prior systemic treatment for advanced disease and esophageal squamous cancer who have progressed following systemic anticancer therapies
. 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 10\^9/L , Serum total bilirubin ≤ 1.5 x ULN (\< 3 x ULN for participants with Gilbert syndrome ), AST and ALT≤ 2.5 x ULN

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Up to 3 Years

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

Timeframe: Up to 4 Years

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

Timeframe: Up to 4 years

The maximum tolerated dose (MTD) of BGB-15025

Timeframe: Up to 3 Years

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

Timeframe: Up to 3 years

RDFE of BGB-15025 in combination with tislelizumab

Timeframe: Up to 3 years

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

Timeframe: Up to 2 years

Trial details

NCT IDNCT04649385

SponsorBeiGene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-17

View on ClinicalTrials.gov More Advanced Solid Tumor trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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, and metastatic including non-small cell lung cancer, and gastric/Gastroesophageal junction cancer that have no prior systemic treatment for advanced disease and esophageal squamous cancer who have progressed following systemic anticancer therapies
. 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 10\^9/L , Serum total bilirubin ≤ 1.5 x ULN (\< 3 x ULN for participants with Gilbert syndrome ), AST and ALT≤ 2.5 x ULN

What they're measuring

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

Timeframe: Up to 3 Years

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

Timeframe: Up to 4 Years

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

Timeframe: Up to 4 years

The maximum tolerated dose (MTD) of BGB-15025

Timeframe: Up to 3 Years

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

Timeframe: Up to 3 years

RDFE of BGB-15025 in combination with tislelizumab

Timeframe: Up to 3 years

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

Timeframe: Up to 2 years

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria