What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as immune modulators and monoclonal antibodies, often have side effects including fatigue, diarrhea, rash, pruritus, and pneumonitis. Severe adverse events can include grade 3 or 4 neutropenia, febrile neutropenia, anemia, and pneumonia. Patients may also experience immune-related adverse events requiring immunosuppressive treatments like steroids. These side effects are consistent with those observed in trials involving similar agents.

What prior FDA approvals exist?

The FDA has approved several immune modulators and cancer treatments for solid tumors. Notable examples include pembrolizumab and nivolumab, both of which are immune checkpoint inhibitors targeting PD-1, and ipilimumab, which targets CTLA-4. These drugs have been approved for various solid tumors, including melanoma, non-small cell lung cancer, and renal cell carcinoma. Combination therapies, such as nivolumab with ipilimumab, have also received approval for enhanced efficacy in treating advanced or metastatic cancers.

What other types of research exist?

Promising novel alternatives to BGB-B167 for solid tumor patients include: 1) Pembrolizumab (KEYNOTE trials) - an immune checkpoint inhibitor showing efficacy in various solid tumors. 2) Atezolizumab (IMpower trials) - another immune checkpoint inhibitor used in combination with chemotherapy. 3) CAR T-cell therapies targeting specific antigens, such as the novel bicistronic CD19.28ζ/CD22.BBζ construct for enhanced cytokine production. 4) Combination therapies involving immune checkpoint inhibitors and other agents, such as Tislelizumab combined with other novel drugs. These alternatives have demonstrated safety and efficacy in clinical trials and represent cutting-edge approaches in cancer treatment.

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Anti-tumor agent

BGB-B167 + Tislelizumab for Solid Cancers

Phase 1

Waitlist Available

Research Sponsored by BeiGene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3 years

Awards & highlights

Summary

This trial is testing a new drug, BGB-B167, alone and with another drug, in people with advanced cancers that haven't responded to other treatments. The drugs aim to boost the immune system's ability to fight cancer. Another drug used in this trial is already approved in China for several types of advanced cancers.

Who is the study for?

Adults over 18 with advanced solid tumors that can't be surgically removed or have spread, and who've tried standard treatments without success or can't tolerate them. They must be relatively healthy (ECOG ≤1) and not have had another cancer in the last 3 years, no active autoimmune diseases, brain metastasis, or severe allergies to similar drugs.

What is being tested?

The trial is testing BGB-B167 alone and combined with Tislelizumab for safety and how it affects the body (pharmacokinetics). It's also looking at whether these treatments shrink tumors in patients with certain types of advanced solid cancers.

What are the potential side effects?

Possible side effects include reactions related to the immune system since both BGB-B167 and Tislelizumab are monoclonal antibodies. These could range from mild allergic reactions to more serious conditions affecting organs due to an overactive immune response.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 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: Maximum tolerated dose (MTD)

Phase 1a: Recommended Phase 2 doses (RP2Ds)

Phase 1b: Objective Response Rate (ORR)

Secondary study objectives

Phase 1a and 1b: Clinical Benefit Rate (CBR)

Phase 1a and 1b: Disease Control Rate (DCR)

Phase 1a and 1b: Duration of Response (DOR)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 1b: Dose ExpansionExperimental Treatment2 Interventions

BGB-B167 alone or in combination with tislelizumab (BGB-A317)

Group II: Phase 1a: Dose EscalationExperimental Treatment2 Interventions

Part A: Increasing dose levels of BGB-B167 monotherapy; Part B: Increasing dose levels of BGB-B167 in combination with tislelizumab (BGB-A317)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tislelizumab

2018

Completed Phase 3

~4560

Do I qualify?Apply below to find out

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 include immune checkpoint inhibitors, targeted therapies, and combination therapies. Immune checkpoint inhibitors, such as anti-PD-1 and anti-CTLA-4 antibodies, work by blocking proteins that prevent the immune system from attacking cancer cells, thereby enhancing the body's immune response against tumors. Targeted therapies, like tyrosine kinase inhibitors, specifically target and inhibit molecules involved in tumor growth and progression. Combination therapies often use multiple agents to target different pathways simultaneously, increasing treatment efficacy. These mechanisms are crucial for solid tumor patients as they offer more precise and effective treatment options, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor

188 Previous Clinical Trials

30,030 Total Patients Enrolled

Study DirectorStudy DirectorBeiGene

1,252 Previous Clinical Trials

504,324 Total Patients Enrolled

Media Library

BGB-B167 (Anti-tumor agent) Clinical Trial Eligibility Overview. Trial Name: NCT05494762 — Phase 1

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

Solid Tumors Clinical Trial 2023: BGB-B167 Highlights & Side Effects. Trial Name: NCT05494762 — Phase 1

BGB-B167 (Anti-tumor agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05494762 — Phase 1

~8 spots leftby Jan 2025

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