BGB-30813 + Tislelizumab for Cancer

Recruiting at 10 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: BeiGene

Disqualifiers: Active autoimmune diseases, CNS metastasis, others

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

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug, BGB-30813, to treat patients with advanced cancer. The goal is to see if this drug can safely help stop or slow down the cancer. The study will find the best dose and check if the treatment improves patients' conditions.

Will I have to stop taking my current medications?

The trial requires that you stop taking any systemic anticancer therapy, including chemotherapy, at least 21 days or 5 half-lives (whichever is shorter) before starting the study drugs. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Tislelizumab for cancer?

Tislelizumab has shown promising anti-tumor effects in various cancers, including Hodgkin's lymphoma, lung cancer, and urothelial carcinoma, and has been approved in China for several cancer types. It has demonstrated meaningful clinical benefits, such as a 24% response rate in patients with advanced urothelial carcinoma, and has a manageable safety profile. ^{1 2 3 4 5}

What makes the drug BGB-30813 + Tislelizumab unique for cancer treatment?

The combination of BGB-30813 and Tislelizumab is unique because Tislelizumab is a modified antibody designed to block a protein called PD-1, which helps cancer cells hide from the immune system. This drug combination may offer a new approach to treating cancers by enhancing the body's immune response against tumors. ^{3 4 5 6 7}

Research Team

Study Director

Principal Investigator

BeiGene

Eligibility Criteria

This trial is for adults with advanced or metastatic solid tumors, including various cancer types like lung, liver, breast, and more. Participants must have tried standard treatments without success or be unable to tolerate them. They should have at least one measurable tumor and be in good physical condition (ECOG score ≤ 1). Women who can bear children must use effective birth control during the study.

Inclusion Criteria

Phase 1b (Dose Expansion): Participants with selected advanced or metastatic solid tumors including NSCLC, HNSCC, and additional potential tumor types to be defined based on emerging data. Must have ≥ 1 measurable lesion per RECIST v1.1. Eastern Cooperative Group Oncology Performance (ECOG) Performance Status score must be ≤ 1. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study. Adequate organ function as indicated by specific laboratory values up to the first dose of study treatment: Hemoglobin ≥ 90 grams per liter (g/L), Absolute neutrophil count ≥ 1.5 x 109/L, Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (< 3 x ULN for participants with Gilbert syndrome), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN.

I have an advanced cancer that cannot be surgically removed and have not been treated with DGK-targeting therapy.

Exclusion Criteria

I have not had treatments targeting DGK.

I do not have active brain or spinal cord tumor spread that is causing symptoms.

Active autoimmune diseases or history of autoimmune diseases that may relapse

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a: Dose Escalation

Participants receive different doses of BGB-30813 alone or with tislelizumab to find the best tolerated dose

Up to approximately 6 months

Phase 1b: Dose Expansion

Selected dose of BGB-30813, alone or with tislelizumab, is given to a larger group to evaluate treatment efficacy

Up to approximately 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BGB-30813
• Tislelizumab

Trial Overview The trial tests BGB-30813 alone and combined with tislelizumab to assess safety and early cancer-fighting effects. It's a two-part study: first finding the right dose (Phase 1a) then expanding that dose to more patients (Phase 1b) among those with specific types of solid tumors.

Participant Groups

Group I: Phase 1b: Dose Expansion BGB-30813 in Combination with Tislelizumab Experimental Treatment 2 Interventions

Group II: Phase 1a: Dose Escalation Part B: BGB-30813 + Tislelizumab Experimental Treatment 2 Interventions

Group III: Phase 1a: Dose Escalation Part A: BGB-30813 Monotherapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

BeiGene

Lead Sponsor

Trials

216

Recruited

32,500+

Findings from Research

Tislelizumab, an anti-PD-1 monoclonal antibody, shows promising efficacy and a manageable safety profile in treating advanced non-small cell lung cancer (NSCLC), with higher affinity to PD-1 compared to other similar therapies like pembrolizumab and nivolumab.

The drug's unique design minimizes binding to macrophages, potentially reducing resistance to treatment, and ongoing trials are exploring its effectiveness in combination with other therapies, which could enhance its role in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tislelizumab: an investigational anti-PD-1 antibody for the treatment of advanced non-small cell lung cancer (NSCLC). Liu, SY., Wu, YL.[2022]

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]

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 is an anti-PD-1 monoclonal antibody developed as an immunotherapy for cancer, specifically approved in December 2019 in China for relapsed or refractory classical Hodgkin's lymphoma after at least two prior chemotherapy treatments.

The drug has shown promise in treating both hematological cancers and advanced solid tumors, indicating its potential for future approvals in additional cancer types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tislelizumab: First Approval. Lee, A., Keam, SJ.[2020]

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 of 115 patients with recurrent or metastatic cervical cancer treated with tislelizumab, the overall response rate was 39.1%, and the median progression-free survival was 19.6 months, indicating promising antitumor activity.

Baseline serum C-reactive protein (CRP) levels and the CRP-to-albumin ratio (CAR) were identified as independent risk factors for predicting the efficacy and prognosis of tislelizumab treatment, with higher levels associated with shorter progression-free and overall survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tislelizumab for cervical cancer: A retrospective study and analysis of correlative blood biomarkers. Zheng, X., Gu, H., Cao, X., et al.[2023]

In a phase I study involving 32 patients with advanced solid tumors, the combination of ociperlimab and tislelizumab was well tolerated, with no dose-limiting toxicities reported and a recommended phase II dose established at ociperlimab 900 mg plus tislelizumab 200 mg every 3 weeks.

Preliminary results showed an overall response rate of 10% and a disease control rate of 50%, indicating some antitumor activity, which supports further investigation in phase II/III trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AdvanTIG-105: a phase I dose escalation study of the anti-TIGIT monoclonal antibody ociperlimab in combination with tislelizumab in patients with advanced solid tumors. Frentzas, S., Kao, S., Gao, R., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Tislelizumab: an investigational anti-PD-1 antibody for the treatment of advanced non-small cell lung cancer (NSCLC). [2022]

2. England pubmed.ncbi.nlm.nih.gov

Tislelizumab in Asian patients with previously treated locally advanced or metastatic urothelial carcinoma. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Tislelizumab: A Modified Anti-tumor Programmed Death Receptor 1 Antibody. [2023]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Tislelizumab: First Approval. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Tislelizumab for Relapsed/Refractory Classical Hodgkin Lymphoma: 3-Year Follow-up and Correlative Biomarker Analysis. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Tislelizumab for cervical cancer: A retrospective study and analysis of correlative blood biomarkers. [2023]

7. England pubmed.ncbi.nlm.nih.gov

AdvanTIG-105: a phase I dose escalation study of the anti-TIGIT monoclonal antibody ociperlimab in combination with tislelizumab in patients with advanced solid tumors. [2023]