BGB-15025 + Tislelizumab for Advanced Cancers

Not currently recruiting at 51 trial locations

Overseen By BeiGene

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: BeiGene

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: Autoimmune diseases, Brain metastasis, others

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

Compensation: Varies

Number of Visits: 21

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, BGB-15025, both alone and with tislelizumab (an immunotherapy drug), to assess safety and determine the best dose for individuals with advanced solid tumors. The research aims to understand how these treatments work, both separately and together, possibly with chemotherapy. It seeks participants with advanced cancers, such as lung or stomach cancer, that have not responded to standard treatments or lack other treatment options. Individuals with a measurable tumor and good organ function may qualify for this study. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new drug.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids or other immunosuppressive medications, you must stop them at least 14 days before the first dose of the study treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids or other immunosuppressive medications, you may need to stop them at least 14 days before starting the trial treatment.

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

Research has shown that BGB-15025, whether used alone or with tislelizumab, is generally well-tolerated. Studies reported no severe side effects that would prevent patients from continuing treatment. Tislelizumab, the other part of the treatment, has been tested in different cancers and has a known safety record. Common side effects include tiredness and low red blood cell count, which can be managed.

These results encourage patients considering joining a trial. Since this trial is in its early stages, the main goal is to ensure the treatment's safety and to find the right dose. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of BGB-15025 and Tislelizumab for advanced cancers because these treatments work differently compared to traditional options. Unlike standard chemotherapy that targets rapidly dividing cells broadly, BGB-15025 is a small molecule inhibitor that potentially targets specific cancer pathways, which may reduce side effects. Tislelizumab, an immune checkpoint inhibitor, helps the immune system recognize and attack cancer cells more effectively. This combination offers a targeted approach that might enhance the body's natural defenses against cancer, providing new hope for patients with advanced stages of the disease.

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

Research has shown that BGB-15025 holds promise in early studies when used alone. In this trial, some participants will receive BGB-15025 alone, while others will receive it combined with Tislelizumab. Earlier research indicated that Tislelizumab alone helped about 24% of patients with advanced bladder cancer, with nearly a quarter experiencing tumor shrinkage. This suggests that BGB-15025, particularly when combined with Tislelizumab, could enhance treatment outcomes. The combination is generally well-tolerated, making it an appealing treatment option. More studies are needed to fully understand its effectiveness, but early results are promising. ^{1 2 4 6 7}

Who Is on the Research Team?

Xiusong Qiu, MD

Principal Investigator

BeiGene

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My blood tests show normal organ function.

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.

I have an advanced cancer that cannot be removed by surgery and have not been treated with HPK1-targeting therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive BGB-15025 monotherapy in sequential cohorts of increasing doses to determine the maximum tolerated dose

Up to 3 years

21-day cycles

Dose Expansion

Based on recommended doses, participants receive BGB-15025 alone or in combination with tislelizumab, with or without chemotherapy

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BGB-15025
• Tislelizumab

Trial Overview 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.

How Is the Trial Designed?

Group I: Phase 1b: Dose Expansion Experimental Treatment 2 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 Escalation Experimental Treatment 2 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 )

Who Is Running the Clinical Trial?

BeiGene

Lead Sponsor

Trials

216

Recruited

32,500+

Published Research Related to This Trial

In a phase II study with 70 patients suffering from relapsed/refractory classical Hodgkin lymphoma, tislelizumab showed a high overall response rate of 87.1% and a complete response rate of 67.1% after a median follow-up of 33.8 months, indicating its efficacy as a treatment option.

The treatment demonstrated a favorable safety profile, with 97.1% of patients experiencing treatment-related adverse events, but only 31.4% having severe (grade ≥3) events, and just 8.6% discontinuing treatment due to adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tislelizumab for Relapsed/Refractory Classical Hodgkin Lymphoma: 3-Year Follow-up and Correlative Biomarker Analysis. Song, Y., Gao, Q., Zhang, H., et al.[2023]

In a study involving 180 patients with advanced solid tumors, the combination of pamiparib and tislelizumab demonstrated an overall objective response rate (ORR) of 20%, with the highest response (47.4%) observed in patients with triple-negative breast cancer (TNBC) who had BRCA1/2 mutations or homologous recombination deficiency.

While the treatment showed promising antitumor activity, it was associated with a significant incidence of treatment-emergent adverse events, with 61.7% of patients experiencing grade 3 or higher side effects, indicating that while the therapy is effective, careful monitoring for safety is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pamiparib in combination with tislelizumab in patients with advanced solid tumours: results from the dose-expansion stage of a multicentre, open-label, phase I trial. Friedlander, M., Mileshkin, L., Lombard, J., et al.[2023]

In a study of 223 patients with locally advanced/metastatic non-squamous non-small cell lung cancer, 57.4% achieved an objective tumor response when treated with tislelizumab combined with chemotherapy, with a median time to response of 7.9 weeks.

The treatment was generally well tolerated, and responders who achieved deeper tumor shrinkage (greater than 30%) showed a trend toward longer progression-free survival, indicating both efficacy and safety of tislelizumab in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Response characteristics of tislelizumab combined with chemotherapy in first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer]. Lu, S., Yu, XM., Hu, YP., et al.[2023]

Tislelizumab is a modified PD-1 antibody that effectively inhibits tumor growth in various cancers, including Hodgkin's lymphoma and lung cancer, and has received multiple approvals in China for its use.

It has a favorable safety profile with common side effects like fatigue and anemia, and it offers economic advantages over other PD-1 inhibitors, making it a promising option for cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tislelizumab: A Modified Anti-tumor Programmed Death Receptor 1 Antibody. Zhang, L., Geng, Z., Hao, B., et al.[2023]

Tislelizumab, an anti-PD-1 monoclonal antibody, showed a confirmed objective response rate of 24% in patients with PD-L1-positive urothelial carcinoma who had progressed after platinum therapy, indicating its efficacy in this challenging patient population.

The treatment had a manageable safety profile, with the most common adverse events being anemia (27%) and pyrexia (19%), and only a small percentage of patients experiencing severe side effects, suggesting that tislelizumab is a viable option for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tislelizumab in Asian patients with previously treated locally advanced or metastatic urothelial carcinoma. Ye, D., Liu, J., Zhou, A., et al.[2022]

In a phase 3 trial involving 332 patients with advanced nonsquamous non-small cell lung cancer (nsq-NSCLC), the combination of tislelizumab and chemotherapy significantly improved progression-free survival (PFS) compared to chemotherapy alone, with a median PFS of 9.7 months versus 7.6 months.

The addition of tislelizumab also resulted in higher response rates and longer duration of response, making it a promising first-line treatment option for patients with advanced nsq-NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tislelizumab Plus Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC (RATIONALE 304): A Randomized Phase 3 Trial. Lu, S., Wang, J., Yu, Y., et al.[2021]

An indirect comparison of tislelizumab and pembrolizumab in combination with chemotherapy for advanced NSCLC, involving over 2,000 participants from 6 randomized trials, showed no significant differences in overall survival, progression-free survival, or objective response rates between the two treatments.

Both treatments were associated with a similar risk of severe adverse events, indicating that either tislelizumab or pembrolizumab can be considered effective and safe options for first-line therapy in advanced NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tislelizumab plus chemotherapy versus pembrolizumab plus chemotherapy for the first-line treatment of advanced non-small cell lung cancer: systematic review and indirect comparison of randomized trials. Guo, Y., Jia, J., Hao, Z., et al.[2023]

Atezolizumab therapy significantly improves overall survival (median OS of 11.2 months) in patients with previously treated advanced non-small cell lung cancer (NSCLC), demonstrating its efficacy in a diverse patient population.

The treatment has a manageable safety profile, with serious adverse events occurring in only 8.0% of patients and no new safety signals identified, indicating it is a viable option for patients often excluded from clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Final results from TAIL: updated long-term efficacy of atezolizumab in a diverse population of patients with previously treated advanced non-small cell lung cancer. Ardizzoni, A., Azevedo, S., Rubio-Viqueira, B., et al.[2022]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.2585

A first-in-human phase 1a dose-escalation study of BGB ... The antitumor activity of BGB-15025 was improved when given in combination with TIS. Further investigation of BGB-15025 + TIS +/- chemotherapy ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04649385

Study Details | NCT04649385 | BGB-15025 Alone and in ... The primary objective of this study is to assess the safety and tolerability of BGB-15025 alone and in combination with tislelizumab; and to determine the ...

3. withpower.com withpower.com/trial/bgb-15025-tislelizumab-for-advanced-cancers-00a98

BGB-15025 + Tislelizumab for Advanced Cancers For example, in patients with advanced urothelial carcinoma, Tislelizumab demonstrated a 24% response rate, meaning nearly a quarter of patients saw their ...

4. beonemedinfo.com beonemedinfo.com/CongressDocuments/Zhou_BGB-A317-15025-101_ESMO_Poster_2025.pdf

A First-in-Human, Phase 1 Study of BGB-15025 ( ... advanced solid tumors (NCT04649385) were presented previously5. – BGB-15025 ± tislelizumab was generally tolerable; BGB-15025 showed greater.

5. clinicaltrials.eu clinicaltrials.eu/inn/bgb-15025-citrate/

Bgb-15025 Citrate – Application in Therapy and Current ... A new treatment option for advanced NSCLC; Possibility of improved outcomes when combined with other treatments; Contribution to the advancement of cancer ...

6. beonemedinfo.com beonemedinfo.com/CongressDocuments/Deva_BGB-A317-15025-101_ASCO_Poster_2024.pdf

A First-in-Human Phase 1a Dose-Escalation Study of BGB- ... BGB-15025 + tislelizumab in patients with advanced solid tumors ... • Safety data are summarized in Table 2. • No dose limiting toxicities ...

7. clinicalresearch.com clinicalresearch.com/en/find-trials/Study/NCT04649385

NCT04649385 The primary objective of this study is to assess the safety and tolerability of BGB-15025 alone and in combination with tislelizumab; and to determine the ...