BGB-26808 + Tislelizumab for Cancer

Recruiting at 28 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: BeiGene

Must not be taking: Corticosteroids, Immunosuppressants, others

Disqualifiers: Uncontrolled diabetes, Active autoimmune diseases, others

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

Compensation: Varies

Number of Visits: Unknown

217 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a new treatment, BGB-26808 (an HPK1 inhibitor), both alone and in combination with another drug, tislelizumab, for individuals with advanced solid tumors. The trial aims to determine the optimal dosage for BGB-26808. It consists of two parts: initially testing different doses, followed by evaluating the best dose with additional treatments like chemotherapy. This trial suits those with advanced cancer that hasn't responded to standard treatments or for whom other treatments aren't suitable. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot have taken certain treatments like corticosteroids or other immunosuppressive medications within 14 days before starting the study. It's best to discuss your current medications with the trial team.

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

Research shows that BGB-26808, used alone or with another drug called tislelizumab, was generally well-tolerated. Some patients experienced side effects, but these were usually manageable, with serious side effects being less common.

Tislelizumab, already approved for some types of cancer, has consistently shown a safe track record in past studies, indicating its safety both alone and with other treatments.

Both treatments have been studied in various contexts, and the safety results appear promising for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BGB-26808 in combination with Tislelizumab because it represents a fresh approach to cancer treatment. Unlike traditional therapies that might target cancer indirectly or broadly, BGB-26808 is designed to work directly on specific cancer pathways, potentially offering a more precise attack on cancer cells. Furthermore, when combined with Tislelizumab, which is an immune checkpoint inhibitor, the treatment may boost the body's immune response against cancer cells, potentially leading to better outcomes. This combination could offer a new hope for patients who have not responded well to existing treatments.

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

Research has shown that BGB-26808, one of the treatments in this trial, has potential in treating cancer when combined with other therapies. Studies have found that 15.4% of patients experienced a reduction in tumor size, with some cases showing complete disappearance and others significant shrinkage.

Tislelizumab, another treatment option in this trial, has demonstrated more impressive results. In some studies, it helped 67% of patients, indicating strong efficacy. It also extended patient survival compared to chemotherapy alone, making it a promising option for advanced cancers. Together, these treatments, as studied in this trial, offer hope for effective cancer management. ^{1 2 5 6 7}

Who Is on the Research Team?

Study Director

Principal Investigator

BeiGene

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that can't be removed by surgery and have had prior treatment. They must have at least one measurable tumor, agree to use effective birth control, provide a tissue sample, and be in good physical condition (ECOG ≤ 1).

Inclusion Criteria

You must be willing to sign a document that details your understanding of the study prior to any related activities.

I can provide a sample of my tumor tissue.

I agree to use effective birth control during and after the study for the required time.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Sequential cohorts of increasing dose levels of BGB-26808 will be evaluated as monotherapy and in combination with tislelizumab

Approximately 1 month

Dose Expansion

Recommended doses for expansion (RDFEs) for BGB-26808 in combination with tislelizumab plus chemotherapy will be evaluated

Approximately 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 12 months

What Are the Treatments Tested in This Trial?

Interventions

• BGB-26808
• Tislelizumab

Trial Overview The study is testing BGB-26808 alone or combined with Tislelizumab in patients with solid tumors. It's an open-label trial aiming to find the best dose of BGB-26808.

How Is the Trial Designed?

Group I: Phase 1b: Dose Expansion Experimental Treatment 3 Interventions

Recommended doses for expansion (RDFEs) for BGB-26808 from Phase 1a in combination with tislelizumab plus chemotherapy will be evaluated.

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

Sequential cohorts of increasing dose levels of BGB-26808 will be evaluated as monotherapy and in combination with tislelizumab.

Who Is Running the Clinical Trial?

BeiGene

Lead Sponsor

Trials

216

Recruited

32,500+

Published Research Related to This Trial

Tislelizumab, an anti-PD-1 monoclonal antibody, shows improved progression-free survival and objective response rates in treating non-small cell lung cancer (NSCLC), especially when combined with chemotherapy, based on a review of four randomized controlled trials involving 1565 patients.

While tislelizumab is generally effective, it is associated with treatment-emergent adverse events, including significant hematologic issues and immune-mediated effects like hypothyroidism and pneumonitis, with a mortality rate from these events ranging from 3.2% to 4.2%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety and efficacy of tislelizumab, alone or in combination with chemotherapy, for the treatment of non-small cell lung cancer: a systematic review of clinical trials. Daei Sorkhabi, A., ZareDini, M., Fazlollahi, A., et al.[2023]

Tislelizumab, a PD-1 inhibitor, significantly improved the overall response rate (ORR) and disease control rate (DCR) in patients with malignant solid tumors, with odds ratios of 2.59 and 1.78, respectively, based on a meta-analysis of seven phase III trials involving 3478 participants.

The treatment also demonstrated improved overall survival (OS) and progression-free survival (PFS), with hazard ratios of 0.71 and 0.68, indicating that tislelizumab is an effective option for patients with solid tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tislelizumab for malignant solid tumor: a systematic review and meta-analysis of phase III randomized trials. Abushanab, AK., Mustafa, MT., Mousa, MT., 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]

Rezivertinib demonstrated a high objective response rate of 64.6% in patients with locally advanced or metastatic NSCLC harboring the EGFR T790M mutation, indicating its efficacy after previous EGFR TKI therapies.

The safety profile of rezivertinib was favorable, with 83.2% of patients experiencing treatment-related adverse events, but only 19.9% having severe (grade 3 or higher) events, and notably, no cases of interstitial lung disease were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Rezivertinib (BPI-7711) in Patients With Locally Advanced or Metastatic/Recurrent EGFR T790M-Mutated NSCLC: A Phase 2b Study. Shi, Y., Wu, S., Wang, K., 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 clinical trial involving 20 patients with EGFR T790M-mutated non-small cell lung cancer (NSCLC), SH-1028 demonstrated manageable safety and promising antitumor activity, particularly at a dose of 200 mg once daily.

The overall objective response rate (ORR) was 40%, with a notable 75% ORR in the 200 mg cohort, indicating that SH-1028 could be an effective treatment option for patients who have progressed after previous EGFR TKI therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, efficacy, and pharmacokinetics of SH-1028 in EGFR T790M-positive advanced non-small cell lung cancer patients: A dose-escalation phase 1 study. He, J., Ma, P., Zhao, D., et al.[2023]

ASP8273, a new tyrosine kinase inhibitor for non-small-cell lung cancer, did not demonstrate improved progression-free survival compared to standard treatments erlotinib or gefitinib, with median PFS of 9.3 months for ASP8273 versus 9.6 months for the comparator group.

Patients receiving ASP8273 experienced a higher rate of severe treatment-emergent adverse events (54.7%) compared to those on erlotinib/gefitinib (43.5%), leading to the study's discontinuation due to concerns over toxicity and limited efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase III, randomized, open-label study of ASP8273 versus erlotinib or gefitinib in patients with advanced stage IIIB/IV non-small-cell lung cancer. Kelly, RJ., Shepherd, FA., Krivoshik, A., et al.[2023]

BPI-15086, a novel third-generation EGFR-TKI, was found to be safe and well-tolerated in a phase I study involving 17 patients with EGFR T790M-mutated non-small-cell lung cancer, with no serious adverse events leading to drug discontinuation.

The treatment showed an objective response rate of 17.7% and a disease control rate of 47.1%, indicating potential efficacy in this patient population, warranting further clinical investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, pharmacokinetics, and efficacy of BPI-15086 in patients with EGFR T790M-mutated advanced non-small-cell lung cancer: results from a phase I, single-arm, multicenter study. Xing, P., Zheng, X., Wang, Y., et al.[2022]

Tislelizumab, a PD-1 inhibitor designed to reduce resistance to therapy, showed a linear pharmacokinetic profile in a study involving 2,596 cancer patients, indicating consistent drug behavior across various doses (0.5-10 mg/kg or a flat 200 mg dose).

Key factors like body weight and tumor characteristics influenced drug clearance, but these had no clinically significant effects, supporting the use of a standard 200 mg dose every 3 weeks for diverse patient populations without the need for adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Model-based population pharmacokinetic analysis of tislelizumab in patients with advanced tumors. Budha, N., Wu, CY., Tang, Z., et al.[2023]

Tyrosine kinases (TKs) are key targets in cancer therapy due to their role in tumor growth and development, and blocking their activity has led to effective treatments for various cancers, including leukemia and solid tumors.

Imatinib, a well-known TK inhibitor, has revolutionized the treatment of chronic myelogenous leukemia, demonstrating the significant impact of TK blockers in clinical oncology, with several other promising inhibitors currently in development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tyrosine kinase blockers: new hope for successful cancer therapy. Pytel, D., Sliwinski, T., Poplawski, T., et al.[2019]

Citations

1. firstwordpharma.com firstwordpharma.com/story/6326263

BeOne Medicines Presents New Data on TEVIMBRA in ... The combination arm achieved an unconfirmed objective response rate (ORR) of 15.4%, including one complete response and seven partial responses.

2. beonemedinfo.com beonemedinfo.com/CongressDocuments/Naing_BGB-A317-26808-101_ESMO_Poster_2025.pdf

First-in-Human, Phase 1 Study of BGB-26808 ( ... combined with immune checkpoint inhibitor (CPI) therapy for effective cancer treatment4,5. • BGB-26808 has been designed with a different ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05981703

NCT05981703 | A Study Investigating BGB-26808 Alone or ... This is an open-label, multicenter, and nonrandomized dose escalation and dose expansion study to evaluate BGB-26808 as monotherapy or in combination with ...

4. afp.com afp.com/ar/node/3800686

BeOne Medicines Presents New Data on TEVIMBRA in ... The combination arm achieved an unconfirmed objective response rate (ORR) of 15.4%, including one complete response and seven partial responses.

5. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/422135

A Study Investigating BGB-26808 Alone or in Combination ... This is an open-label, multicenter, and nonrandomized dose escalation and dose expansion study to evaluate BGB-26808 as monotherapy or in combination with ...

6. beonemedinfo.com beonemedinfo.com/CongressDocuments/Naing_BGB-A317-26808-101_ESMO_Abstract_2025.pdf

ESMO 2025 First-in-human, phase 1 study of BGB-26808 ( ... Conclusion: Preliminary data show BGB-26808 ± TIS was generally tolerable and potential antitumor activity of BGB-26808 was shown combined with TIS. Further ...

7. biospace.com biospace.com/press-releases/beone-medicines-presents-new-data-on-tevimbra-in-lung-cancer-at-esmo-2025

BeOne Medicines Presents New Data on TEVIMBRA in ... Safety was manageable in patients with advanced, metastatic, and unresectable solid tumors. Grade 3 or 4 TRAEs with single-agent BGB-26808 were ...