~15 spots leftby Oct 2025

BGB-15025 + Tislelizumab for Advanced Cancers

Recruiting in Palo Alto (17 mi)
+41 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: BeiGene
No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the idea that BGB-15025 + Tislelizumab for Advanced Cancers is an effective treatment?

The available research shows that Tislelizumab, when used in combination with other treatments, has shown promising results in treating various advanced cancers. For example, in patients with advanced urothelial carcinoma, Tislelizumab demonstrated a 24% response rate, meaning nearly a quarter of patients saw their cancer shrink or disappear. Additionally, Tislelizumab has been compared to another drug, Pembrolizumab, for lung cancer treatment, and both showed similar effectiveness in improving patient outcomes. This suggests that Tislelizumab, including when combined with BGB-15025, could be an effective option for treating advanced cancers.12345

What safety data is available for BGB-15025 and Tislelizumab in treating advanced cancers?

Tislelizumab, an anti-PD-1 antibody, has been studied in various cancers and shows an acceptable safety profile. Common adverse effects include fatigue, anemia, and decreased neutrophil count, with serious events like respiratory infection or hepatic injury being rare. In combination with chemotherapy for non-small cell lung cancer, it was well tolerated with a safety profile similar to the overall population. In urothelial carcinoma, common treatment-related adverse events were anemia and pyrexia, with some grade 3-4 events like anemia and hyponatremia. Three deaths were possibly related to treatment. Overall, Tislelizumab demonstrates manageable safety in these studies.24567

Is the drug BGB-15025, Tislelizumab a promising treatment for advanced cancers?

Yes, Tislelizumab is a promising drug for advanced cancers. It has shown positive effects in treating various types of cancer, including lung, liver, and stomach cancers. It is designed to help the immune system fight cancer more effectively and has been approved for use in several countries. It also offers an economic advantage, making it a valuable option for cancer treatment.23458

Research Team

XQ

Xiusong Qiu, MD

Principal Investigator

BeiGene

Eligibility Criteria

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.
See 2 more

Treatment Details

Interventions

  • BGB-15025 (Other)
  • Tislelizumab (PD-1 Inhibitor)
Trial OverviewThe 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.
Participant Groups
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 )

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Oncology ConsultantsHouston, TX
MD AndersonHouston, TX
One Gustave L Levy PlaceNew York, NY
Icahn School of Medicine At Mount SinaiNew York, NY
More Trial Locations
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Who Is Running the Clinical Trial?

BeiGene

Lead Sponsor

Trials
216
Patients Recruited
32,500+

Findings from Research

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]
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]
Tislelizumab for Relapsed/Refractory Classical Hodgkin Lymphoma: 3-Year Follow-up and Correlative Biomarker Analysis.Song, Y., Gao, Q., Zhang, H., et al.[2023]
Tislelizumab: A Modified Anti-tumor Programmed Death Receptor 1 Antibody.Zhang, L., Geng, Z., Hao, B., et al.[2023]
Tislelizumab in Asian patients with previously treated locally advanced or metastatic urothelial carcinoma.Ye, D., Liu, J., Zhou, A., et al.[2022]
[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]
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]
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]

References

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. [2023]
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. [2023]
Tislelizumab for Relapsed/Refractory Classical Hodgkin Lymphoma: 3-Year Follow-up and Correlative Biomarker Analysis. [2023]
Tislelizumab: A Modified Anti-tumor Programmed Death Receptor 1 Antibody. [2023]
Tislelizumab in Asian patients with previously treated locally advanced or metastatic urothelial carcinoma. [2022]
[Response characteristics of tislelizumab combined with chemotherapy in first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer]. [2023]
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. [2022]
Tislelizumab Plus Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC (RATIONALE 304): A Randomized Phase 3 Trial. [2021]