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BGB-15025 + Tislelizumab for Advanced Cancers

Phase 1
Recruiting
Research Sponsored by BeiGene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study Summary

This trial is testing the safety and tolerability of a new drug, BGB-15025, alone and in combination with another drug, tislelizumab. The goal is to find the maximum tolerated dose (MTD) or maximum administered dose (MAD) of BGB-15025.

Who is the study for?
This trial is for adults with advanced solid tumors, including lung, esophageal, or stomach cancers that have worsened after treatment or haven't been treated yet. They must be relatively healthy (ECOG ≤ 1) and have at least one tumor that can be measured. People who've had prior HPK1-targeted therapy or don't meet specific blood and organ function tests cannot join.Check my eligibility
What is being tested?
The study is testing the safety of a new drug called BGB-15025 alone and when used with Tislelizumab in patients with advanced solid tumors. It aims to find the highest dose patients can take without serious side effects and suggest doses for future Phase 2 trials.See study design
What are the potential side effects?
Possible side effects include typical reactions to cancer drugs such as fatigue, nausea, skin issues, immune system responses like inflammation in various organs, potential liver enzyme changes indicated by blood tests, and other symptoms based on individual tolerance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have advanced cancer that cannot be removed by surgery and have either tried other cancer treatments without success or have not received any treatments for my advanced disease.
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I have an advanced cancer that cannot be removed by surgery and have not been treated with HPK1-targeting therapy.
Select...
I can carry out all my self-care but not work activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1a: Number of Participants Experiencing Adverse Events (AEs)
Phase 1a: Number of Participants Experiencing Serious Adverse Events (SAEs)
Phase 1a: Number of participants with dose limiting toxicities (DLTs)
+4 more
Secondary outcome measures
Disease Control Rate (DCR) as assessed by the investigator
Duration Of Response (DOR) as assessed by the investigator
Phase 1a: Accumulation Ratio for AUC of BGB-15025
+15 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 1b: Dose ExpansionExperimental Treatment2 Interventions
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
Group II: Phase 1a: Dose EscalationExperimental Treatment2 Interventions
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 )
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tislelizumab
2018
Completed Phase 3
~4260

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor
175 Previous Clinical Trials
28,484 Total Patients Enrolled
Xiusong Qiu, MDStudy DirectorBeiGene

Media Library

Solid Tumors Research Study Groups: Phase 1b: Dose Expansion, Phase 1a: Dose Escalation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for enrolment into this medical experiment?

"According to clinicaltrials.gov, this medical research is still open for recruitment with the original post being made on March 4th 2021 and later edited on November 2nd 2021."

Answered by AI

To what extent is the current trial enrolling patients?

"Affirmative, records on clinicaltrials.gov evince that this scientific trial is actively enrolling individuals. This experiment was initially advertised on March 4th 2021 and its latest update was November 2nd of the same year. 240 persons are expected to be recruited from two distinct sites."

Answered by AI

What data has been accumulated regarding the efficacy of BGB-15025 in clinical trials?

"At present, there are 105 studies running examining BGB-15025's efficacy; 18 of these live trials are in their final stage. While the majority of research is located within Nanning, Guangxi, 2329 sites globally have launched investigations into this drug treatment."

Answered by AI

Is this a pioneering endeavor in its field?

"The pharmaceutical BeiGene has overseen 105 active trials of BGB-15025 in 426 cities and 45 nations since the first trial commenced four years ago. This initial Phase 3 study, involving 805 participants, concluded successfully in 2017, with 11 further studies having since been completed."

Answered by AI

Has BGB-15025 been officially sanctioned by the FDA?

"The safety of BGB-15025 is uncertain, resulting in a score of 1 since this is an early phase trial. Thus far, the evidence backing its efficacy and safety have been minimal."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
BGB-15025 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Participants With Advanced Solid Tumors
2021. "BGB-15025 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Participants With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04649385.
~81 spots leftby Apr 2025
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