BGB-30813 + Tislelizumab for Cancer

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment, BGB-30813, both alone and combined with Tislelizumab (an immunotherapy), to assess their safety and effectiveness for people with advanced solid tumors. These tumors have spread and cannot be easily removed by surgery. The trial consists of two parts: first, determining the best dose, and then expanding to evaluate the treatment's effectiveness. It seeks participants with specific types of cancer, such as certain lung or head and neck cancers, who have tried other treatments or have no other options. Those who have not tried drugs targeting a protein called DGK might be suitable for this trial. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

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.

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

Research shows that BGB-30813, when combined with the drug tislelizumab, has produced promising results in treating certain cancers. In earlier studies, this combination achieved a 24% success rate in patients with advanced bladder cancer. Importantly, the side effects were manageable, meaning they were neither too severe nor unexpected.

Tislelizumab alone is a drug that helps the immune system fight cancer cells and has been effective in patients with a specific type of bladder cancer.

Since this trial is in an early stage, it primarily focuses on the safety and tolerability of these treatments. The main goal is to ensure participants can handle the treatments well, even as researchers continue to learn about their effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BGB-30813 and Tislelizumab because they offer a fresh approach to cancer treatment. Unlike the standard chemotherapy and targeted therapies that often attack both healthy and cancerous cells, BGB-30813 is designed to specifically target cancer cells, potentially reducing side effects. Tislelizumab, on the other hand, is an immunotherapy that helps the body's immune system recognize and fight cancer more effectively. The combination of these two treatments could enhance the body's natural defenses while directly targeting cancer cells, offering a new hope for patients with fewer treatment options.

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

Research has shown that BGB-30813 is being developed to treat advanced solid tumors. Early results suggest promise, especially for cancers that have previously responded to similar treatments. In this trial, some participants will receive BGB-30813 alone, while others will receive it with tislelizumab, a drug that helps the immune system fight cancer. Tislelizumab has already demonstrated a 24% success rate in some cancer patients, indicating potential effectiveness. Together, these treatments might provide a new option for people with difficult-to-treat cancers. ^{3 4 6 7 8}

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 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

Active autoimmune diseases or history of autoimmune diseases that may relapse

I have not had treatments targeting DGK.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05904496

NCT05904496 | A Study of BGB-30813 Alone or in ... This study will test whether taking BGB-30813 alone or with tislelizumab can help treat patients with cancer that has spread throughout the body or is locally ...

2. withpower.com withpower.com/trial/phase-1-solid-tumors-advanced-solid-tumors-6-2023-e3ab3

BGB-30813 + Tislelizumab for Cancer · Info for Participants 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 ...

3. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT05904496/

Trial | NCT05904496 This study will test whether taking BGB-30813 alone or with tislelizumab can help treat patients with cancer that has spread throughout the body or is locally ...

4. veri.larvol.com veri.larvol.com/news/baize-an-tislelizumab/drug

News - Tevimbra (tislelizumab-jsgr) In patients with advanced nsq-NSCLC and PD-L1 tumor cell expression ≥ 50%, first-line tislelizumab plus chemotherapy demonstrated clinically meaningful ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10644399/

Small molecule inhibitors for cancer immunotherapy and ... BGB-30813 is a DGKζ inhibitor in early clinical development in combination with BeiGene's anti-PD-1 antibody tislelizumab (NCT5904496). In summary, dual ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05904496

NCT05904496 | A Study of BGB-30813 Alone or in ... This study will test whether taking BGB-30813 alone or with tislelizumab can help treat patients with cancer that has spread throughout the body or is locally ...

7. beonemedicines.com beonemedicines.com/clinical-trials/a-study-investigating-the-safety-tolerability-pharmacokinetics-and-preliminary-antitumor-activity-of-bgb-30813/

BGB-A317-30813-101 A study of BGB-30813 alone or in combination with Tislelizumab in participants with advanced or metastatic solid tumors.

8. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-00267

A Study of BGB-30813 Alone or in Combination With ... This is a First in Human (FIH) Phase 1, multicenter, open label, dose escalation and dose expansion study to evaluate the safety, tolerability, ...