What side effects are associated with this type of intervention?

Common treatments for solid tumors, particularly those targeting tumor growth or survival pathways like BGB-24714, often include chemotherapy, targeted therapy, and immunotherapy. Known side effects include myelosuppression (neutropenia, anemia, thrombocytopenia), gastrointestinal issues (nausea, vomiting, diarrhea, constipation), fatigue, neuropathy, and skin reactions. Targeted therapies and immunotherapies can also cause specific toxicities such as hypertension, hypothyroidism, and immune-related adverse events like pneumonitis, colitis, and hepatitis.

What prior FDA approvals exist?

The FDA has approved several anti-cancer agents for the treatment of solid tumors that target tumor growth or survival pathways. Notable examples include tyrosine kinase inhibitors like pazopanib and sunitinib, which inhibit multiple receptor tyrosine kinases involved in tumor growth and angiogenesis. Immune checkpoint inhibitors such as pembrolizumab and nivolumab, which target PD-1/PD-L1 pathways to enhance the immune system's ability to fight cancer, have also been approved. Additionally, bevacizumab, an anti-VEGF antibody, is used to inhibit angiogenesis in various solid tumors. These agents represent a broad spectrum of targeted therapies aimed at disrupting key pathways essential for tumor survival and proliferation.

What other types of research exist?

Promising novel alternatives to BGB-24714 for solid tumor patients include multitargeted kinase inhibitors such as regorafenib, cabozantinib, sorafenib, and lenvatinib. These agents target VEGFR and other kinases and have shown some activity in advanced solid tumors. Additionally, immune checkpoint inhibitors like pembrolizumab and nivolumab, often used in combination with other therapies, are also promising options.

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Epigenetic Modulator

BGB-24714 + Combination Therapies for Solid Tumors

Phase 1

Recruiting

Research Sponsored by BeiGene

Eligibility Criteria Checklist

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

Must have

Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumor previously treated with standard systemic therapy or for whom treatment is not available or not tolerated.

Patients must be able to provide an archived formalin-fixed paraffin embedded (FFPE) tumor tissue sample. If archival tissue is not available, fresh tumor biopsy is mandatory.

Must not have

Clinically significant infection requiring systemic therapy ≤ 14 days before the first dose of study drug(s).

Active leptomeningeal disease or uncontrolled, untreated brain metastasis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a drug called BGB-24714, alone or with other treatments, for people with advanced solid tumors. The goal is to find the highest safe dose to use in future studies.

Who is the study for?

This trial is for adults with advanced solid tumors that have grown or spread despite standard treatments, or when no treatment options are available. Participants must be in relatively good health and physical condition (ECOG ≤1), able to provide a tumor tissue sample, and not have had certain other cancers or major surgeries recently. They also can't be on steroids or similar meds within 14 days of starting the study.

What is being tested?

The trial is testing BGB-24714's safety and tolerability as a standalone treatment and alongside chemotherapy drugs like Carboplatin and Paclitaxel, as well as radiation therapy. It aims to find the highest dose patients can take without severe side effects for future studies.

What are the potential side effects?

Possible side effects include reactions at the injection site, fatigue, nausea, low blood cell counts leading to increased infection risk or bleeding problems, nerve damage causing numbness or tingling sensations, hair loss due to chemotherapy agents like Carboplatin and Paclitaxel.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My advanced cancer cannot be surgically removed and I've either tried standard treatments without success or can't tolerate them.

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I can provide a sample of my tumor, either previously stored or newly taken.

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I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a serious infection needing treatment in the last 2 weeks.

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I do not have active brain metastasis or untreated brain cancer spread.

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I have been treated with Smac mimetics or similar drugs before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 2 years

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

Treatment Details

Study Objectives

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

Primary study objectives

Dose Escalation: Number of participants with adverse events (AEs)

Dose Escalation: Recommended Doses for Expansion (RDFE) of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with concurrent chemoradiotherapy (cCRT)

Dose Expansion: Objective response rate (ORR)

Secondary study objectives

Clinical Benefit Rate (CBR)

Disease Control Rate (DCR)

Dose Escalation: Objective response rate (ORR)

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

7Treatment groups

Experimental Treatment

Group I: Phase 1b: Dose ExpansionExperimental Treatment4 Interventions

BGB 24714 will be administered in combination with paclitaxel or docetaxel in participants with selected solid tumors.

Group II: Phase 1a: Dose Escalation Part EExperimental Treatment3 Interventions

Participants will receive increasing dose levels of BGB-24714 in combination with chemoradiation in Chinese participants

Group III: Phase 1a: Dose Escalation Part DExperimental Treatment3 Interventions

Participants will receive increasing dose levels of BGB-24714 in combination with chemoradiation

Group IV: Phase 1a: Dose Escalation Part CExperimental Treatment3 Interventions

Participants will receive increasing dose levels of BGB-24714 in combination with chemoradiation

Group V: Phase 1a: Dose Escalation Part BExperimental Treatment2 Interventions

Participants will receive increasing dose levels of BGB-24714 in combination with paclitaxel

Group VI: Phase 1a: Dose Escalation Part A-CNExperimental Treatment1 Intervention

Participants will receive escalating doses of BGB-24714 as monotherapy in Chinese participants

Group VII: Phase 1a: Dose Escalation Part AExperimental Treatment1 Intervention

Participants will receive escalating doses of BGB-24714 as monotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Paclitaxel

2011

Completed Phase 4

~5450

Docetaxel

1995

Completed Phase 4

~6550

0 / 6Eligibility criteria met

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

Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect normal cells, leading to side effects. Targeted therapies, such as tyrosine kinase inhibitors and monoclonal antibodies, specifically target molecules involved in tumor growth and survival pathways, thereby minimizing damage to normal cells. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. These mechanisms are crucial for solid tumor patients as they offer more precise and potentially less toxic treatment options, improving outcomes and quality of life. Investigational agents like BGB-24714, which target specific tumor growth or survival pathways, represent a promising advancement in this therapeutic landscape.