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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 2 years

Awards & highlights

Study Summary

This trial is testing a new cancer drug, BGB-24714, to see if it is safe and effective. The study will enroll people with advanced or metastatic solid tumors.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose Escalation: Maximum tolerated dose (MTD) of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with concurrent chemoradiotherapy (cCRT)

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)

+1 more

Secondary outcome measures

Apparent Clearance (CL/F) of BGB-24714

Apparent Volume Of Distribution (Vz/F) of BGB-24714

Area Under The Plasma Concentration Time Curve From Time 0 To Infinity (AUC0-inf) of BGB-24714 and its metabolite

+15 more

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 mainland China

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 mainland China

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

Paclitaxel

2011

Completed Phase 4

~5380

Carboplatin

2014

Completed Phase 3

~6670

Docetaxel

1995

Completed Phase 4

~5620

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor

175 Previous Clinical Trials

28,585 Total Patients Enrolled

Media Library

BGB-24714 (Epigenetic Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05381909 — Phase 1

Solid Tumors Research Study Groups: Phase 1a: Dose Escalation Part A, Phase 1a: Dose Escalation Part D, Phase 1b: Dose Expansion, Phase 1a: Dose Escalation Part E, Phase 1a: Dose Escalation Part B, Phase 1a: Dose Escalation Part C, Phase 1a: Dose Escalation Part A-CN

Solid Tumors Clinical Trial 2023: BGB-24714 Highlights & Side Effects. Trial Name: NCT05381909 — Phase 1

BGB-24714 (Epigenetic Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05381909 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree could BGB-24714 endanger human health?

"Considering the minimal amount of data available on BGB-24714, our team at Power has assigned a safety score of 1 to this compound. This is due to it being in Phase 1 clinical trials, thus yielding limited evidence for both efficacy and safety."

Answered by AI

Does this investigation have openings for new participants?

"Affirmative. Clinicaltrials.gov records show that this clinical trial is currently enrolling participants–it was initially posted on July 6th 2022 and most recently updated on August 19th of the same year. A total of 244 subjects are needed to be recruited from 4 different medical sites."

Answered by AI

How many hospitals are offering this trial to patients within the state?

"The trial is primarily based out of Massachusetts General Hospital in Boston, Tennessee Oncology PLLC in Nashville and the University of Washington in Seattle. Additionally, it has 4 other sites spread across the nation."

Answered by AI

What is the current size of this trial's participant pool?

"Affirmative. Clinicaltrials.gov has evidence of this clinical trial actively searching for participants, beginning on July 6th 2022 and most recently being updated on August 19th 2022. This study aims to recruit 244 patients from 4 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study Investigating BGB-24714 as Monotherapy and With Combination Therapies in Participants With Solid Tumors

2022. "Study Investigating BGB-24714 as Monotherapy and With Combination Therapies in Participants With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05381909.