BGB-B167 + Tislelizumab for Solid Cancers

Recruiting at 14 trial locations

Overseen By BeiGene

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: BeiGene

Disqualifiers: Autoimmune diseases, Brain metastasis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

55 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Study Director

Principal Investigator

BeiGene

Eligibility Criteria

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.

Inclusion Criteria

I am fully active or can carry out light work.

My recent lab tests show my organs are working well.

I am 18 years old or older.

Exclusion Criteria

I am not pregnant or breastfeeding.

History of severe hypersensitivity reactions to other monoclonal antibody products or their excipients

I do not have untreated brain cancer spread or active spinal cord cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive increasing dose levels of BGB-B167 monotherapy or in combination with tislelizumab to determine the maximum tolerated dose and recommended phase 2 doses

Up to 90 days after the last dose of study drug(s)

Dose Expansion

Participants receive BGB-B167 alone or in combination with tislelizumab to evaluate objective response rate and other efficacy measures

Up to approximately 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BGB-B167
• Tislelizumab

Trial Overview 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.

Participant Groups

Group I: Phase 1b: Dose Expansion Experimental Treatment 2 Interventions

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

Group II: Phase 1a: Dose Escalation Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

BeiGene

Lead Sponsor

Trials

216

Recruited

32,500+