BGB-B167 + Tislelizumab for Solid Cancers

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment combination for advanced solid tumors that have not responded well to other therapies. It tests the safety and effectiveness of BGB-B167 (an experimental treatment) both alone and in combination with another drug, tislelizumab (also known as Tizveni or Tevimbra). The study consists of two parts: one to determine the right dose of BGB-B167 and another to evaluate its effectiveness with tislelizumab. Individuals with advanced cancer that cannot be surgically removed and have not had success with other treatments might be suitable candidates for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that BGB-B167, both alone and with the drug tislelizumab, is well tolerated by patients with advanced solid tumors. Studies found that participants experienced few serious side effects, indicating the treatment's relative safety. Tislelizumab, also part of this trial, has already demonstrated safety in other studies for different solid tumors. Together, these treatments have shown only minor differences in side effects and appear safe for people in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BGB-B167 and tislelizumab for treating solid cancers because they offer a novel approach compared to standard therapies like chemotherapy and radiation. BGB-B167 is a unique treatment, as it potentially works by targeting specific proteins involved in cancer cell growth, which could lead to more precise cancer inhibition. Tislelizumab, on the other hand, is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells more effectively. This combination aims to enhance the body's natural defenses against cancer, offering hope for more effective and targeted cancer treatments.

What evidence suggests that this trial's treatments could be effective for solid cancers?

Research has shown that BGB-B167, one of the treatments in this trial, is generally well tolerated by patients with advanced solid tumors, whether used alone or with another drug called tislelizumab. However, its tumor-fighting ability has been limited so far. Tislelizumab alone, also under study in this trial, has effectively treated some solid tumors. The trial aims to combine these treatments to enhance the body's immune response against cancer cells. Although the research remains in early stages, there is hope that this combination could offer a new treatment option for cancers unresponsive to other therapies. ^{3 4 6 7 8}

Who Is on the Research Team?

Study Director

Principal Investigator

BeiGene

Are You a Good Fit for This Trial?

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.

My cancer is advanced, cannot be surgically removed, and I've either tried all standard treatments, can't tolerate them, or they're not expected to help much.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. beonemedinfo.com beonemedinfo.com/CongressDocuments/Desai_BGB-B167_ASCO-GI_Poster_2025.pdf

Despite the approval of immune checkpoint inhibitors for the • Overall, BGB-B167 as monotherapy or in combination with tislelizumab was well tolerated, with minor differences observed between dose levels (Table 2).

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-10694

Safety, Pharmacokinetics, and Antitumor Activity of BGB ... This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BGB-B167 monotherapy and in combination with ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12265466/

Long-term safety analysis of pooled data for tislelizumab as ... Tislelizumab, an anti-programmed cell death protein 1 monoclonal antibody, has demonstrated efficacy and safety in solid tumors.

4. withpower.com withpower.com/trial/phase-1-tumors-solid-7-2022-062a3

BGB-B167 + Tislelizumab for Solid Cancers 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.

5. meetings.asco.org meetings.asco.org/abstracts-presentations/243336

Abstract Conclusions: Overall, BGB-B167 ± TIS was well tolerated and has demonstrated limited antitumor activity in pts with advanced/metastatic CEA+ solid tumors.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05644626

Safety, Pharmacokinetics and Antitumor Activity of BGB ... Sponsor determined the data was no longer needed. Safety, Pharmacokinetics and Antitumor Activity of BGB-B167 Alone and in Combination With Tislelizumab in ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.123

First-in-human, phase 1a, dose escalation study of BGB- ... Overall, BGB-B167 ± TIS was well tolerated and has demonstrated limited antitumor activity in pts with advanced/metastatic CEA+ solid tumors.

8. careacross.com careacross.com/clinical-trials/trial/NCT05494762

Safety, Pharmacokinetics, and Antitumor Activity of BGB ... Summary: This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BGB-B167 monotherapy and in combination ...