What side effects are associated with this type of intervention?

Common side effects of treatments for solid tumors, particularly those involving anti-PD-1 monoclonal antibodies like Tislelizumab, include immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies (e.g., hypothyroidism), and skin reactions (e.g., rash). Chemotherapy, often used in combination with these immunotherapies, can cause nausea, vomiting, fatigue, myelosuppression (leading to anemia, neutropenia, and thrombocytopenia), and increased risk of infections. The combination of these therapies aims to enhance anti-tumor efficacy but also requires careful management of the associated toxicities.

What prior FDA approvals exist?

FDA approvals for the treatment of solid tumors have included several anti-PD-1 monoclonal antibodies, such as Pembrolizumab and Nivolumab. These drugs have been approved for various cancers, including non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), and melanoma, based on their demonstrated improvements in overall survival (OS) and progression-free survival (PFS). Additionally, combinations of anti-PD-1 therapies with chemotherapy or other immunotherapies have also been approved to enhance treatment efficacy in advanced solid tumors.

What other types of research exist?

Promising novel alternatives for solid tumor patients include: 1) Atezolizumab (Anti-PD-L1) in combination with chemotherapy, which has shown improved overall survival in various cancers. 2) Pembrolizumab (Anti-PD-1) combined with chemotherapy, which has demonstrated efficacy in non-small cell lung cancer and other solid tumors. 3) Bispecific antibodies, such as those targeting T-cells and tumor antigens, which are emerging as competitors to CAR T-cell therapies. 4) Novel agents targeting immune checkpoints or tumor-specific pathways, such as nivolumab (Anti-PD-1) and ipilimumab (Anti-CTLA-4) combinations, which have shown promise in renal cell carcinoma and other cancers.

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Other

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 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, BGB-15025, alone and with an immune-boosting drug, tislelizumab, in patients with advanced cancer. The goal is to see if these treatments are safe and to find the best dose.

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.

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.

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.

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I can carry out all my self-care but not work activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

RDFE of BGB-15025 in combination with tislelizumab

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

+1 more

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~4700

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors often include immune checkpoint inhibitors like Tislelizumab, an anti-PD-1 monoclonal antibody. Tislelizumab blocks the PD-1 pathway, which tumors use to evade the immune system, thereby reactivating T-cells to recognize and attack cancer cells. This targeted approach is significant for solid tumor patients as it enhances the body's immune response against cancer. Emerging therapies like BGB-15025, though their mechanisms are still under investigation, are being studied for their potential to improve treatment outcomes when used alone or in combination with immune checkpoint inhibitors.

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