What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as immune checkpoint inhibitors (e.g., tislelizumab), chemotherapy, and targeted therapies, often have a range of side effects. Immune checkpoint inhibitors can cause immune-related adverse events, including fatigue, rash, diarrhea, and pneumonitis. Chemotherapy is associated with side effects like nausea, vomiting, hair loss, and myelosuppression, which can lead to increased risk of infections. Targeted therapies may cause specific side effects depending on the drug, such as skin rashes, hypertension, and liver toxicity. It is important for patients to discuss potential side effects with their healthcare provider to manage and mitigate these risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for solid tumors, particularly those involving immune checkpoint inhibitors and combination therapies. Pembrolizumab (Keytruda) and nivolumab (Opdivo) are notable examples of PD-1 inhibitors approved for various solid tumors, including non-small cell lung cancer and melanoma. Additionally, combination therapies such as pembrolizumab with chemotherapy (e.g., pemetrexed and platinum) and atezolizumab (Tecentriq) with bevacizumab and chemotherapy have shown efficacy in treating metastatic non-squamous non-small-cell lung cancer. These treatments are similar to the investigational drug BGB-30813, which is being studied for its potential antitumor activity in combination with tislelizumab, another immune checkpoint inhibitor.

What other types of research exist?

Promising novel alternatives to BGB-30813 for solid tumor patients include: 1) Tislelizumab, which is being studied in combination with BGB-30813 and has shown potential antitumor activity. 2) Cabozantinib, which has demonstrated efficacy in advanced Ewing sarcoma and osteosarcoma. 3) Regorafenib, which has shown efficacy in metastatic osteosarcoma. 4) Niraparib, a PARP inhibitor evaluated in metastatic castration-resistant prostate cancer with HRR gene abnormalities. These alternatives are in advanced clinical trials and have shown promising results in terms of efficacy and safety.

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BGB-30813 + Tislelizumab for Cancer

Phase 1

Waitlist Available

Research Sponsored by BeiGene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 2 years and 11 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include typical reactions related to immune therapies such as fatigue, skin reactions, digestive issues, changes in blood counts or liver enzymes which will be closely monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 2 years and 11 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 2 years and 11 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years and 11 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1a and 1b: Recommended dose(s) for Expansion (RDFE[s]) of BGB-30813 Alone or in Combination with Tislelizumab

Phase 1a: Dose Escalation: Number of Participants Experiencing Adverse Events (AEs), Serious Adverse Events (SAEs) and Dose-Limiting Toxicities (DLTs)

Phase 1a: Dose Escalation: The Maximum Tolerated Dose (MTD) and Maximum Administered Dose (MAD)

+1 more

Secondary study objectives

Phase 1a: Dose Escalation: ORR as Determined by the Investigator

Phase 1b: Dose Expansion: Clinical Benefit Rate (CBR)

Phase 1b: Dose Expansion: Disease Control Rate (DCR)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Phase 1b: Dose Expansion BGB-30813 in Combination with TislelizumabExperimental Treatment2 Interventions

Group II: Phase 1a: Dose Escalation Part B: BGB-30813 + TislelizumabExperimental Treatment2 Interventions

Group III: Phase 1a: Dose Escalation Part A: BGB-30813 MonotherapyExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tislelizumab

2018

Completed Phase 3

~4700

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for solid tumors include targeted therapies, immunotherapies, and combination therapies. Targeted therapies, such as tyrosine kinase inhibitors, work by specifically targeting and inhibiting molecular pathways that are essential for tumor cell growth and survival. Immunotherapies, like checkpoint inhibitors (e.g., tislelizumab), enhance the body's immune response against cancer cells by blocking proteins that suppress immune activity. Combination therapies, which may include investigational drugs like BGB-30813, aim to enhance antitumor efficacy by using multiple agents that target different mechanisms of tumor growth and immune evasion. These treatments are crucial for solid tumor patients as they offer more precise and potentially more effective options compared to traditional chemotherapy, leading to improved outcomes and reduced side effects.