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

NCT ID: NCT05381909

Last Updated: 2026-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-06

Study Completion Date

2025-07-25

Brief Summary

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This study aims to understand how safe and well-tolerated a drug called BGB-24714 is when used alone, or in combination with chemotherapy or radiation therapy, for people with advanced or spreading solid tumors. The main objective is to identify the highest tolerable dose or the highest administered dose of BGB-24714. Additionally, the study aims to identify the most suitable doses for further investigation in larger groups of participants.

Detailed Description

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Conditions

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Solid Tumor, Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1a: Dose Escalation Part E

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

Group Type EXPERIMENTAL

Carboplatin

Intervention Type DRUG

administered intravenously

BGB-24714

Intervention Type DRUG

administered orally

Paclitaxel

Intervention Type DRUG

administered intravenously

Phase 1b: Dose Expansion

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

Group Type EXPERIMENTAL

Docetaxel

Intervention Type DRUG

administered intravenously

BGB-24714

Intervention Type DRUG

administered orally

Paclitaxel

Intervention Type DRUG

administered intravenously

Phase 1a: Dose Escalation Part C

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

Group Type EXPERIMENTAL

Carboplatin

Intervention Type DRUG

administered intravenously

BGB-24714

Intervention Type DRUG

administered orally

Paclitaxel

Intervention Type DRUG

administered intravenously

Phase 1a: Dose Escalation Part D

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

Group Type EXPERIMENTAL

Carboplatin

Intervention Type DRUG

administered intravenously

BGB-24714

Intervention Type DRUG

administered orally

Paclitaxel

Intervention Type DRUG

administered intravenously

Phase 1a: Dose Escalation Part A-CN

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

Group Type EXPERIMENTAL

BGB-24714

Intervention Type DRUG

administered orally

Phase 1a: Dose Escalation Part A

Participants will receive escalating doses of BGB-24714 as monotherapy

Group Type EXPERIMENTAL

BGB-24714

Intervention Type DRUG

administered orally

Phase 1a: Dose Escalation Part B

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

Group Type EXPERIMENTAL

BGB-24714

Intervention Type DRUG

administered orally

Paclitaxel

Intervention Type DRUG

administered intravenously

Interventions

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Carboplatin

administered intravenously

Intervention Type DRUG

Docetaxel

administered intravenously

Intervention Type DRUG

BGB-24714

administered orally

Intervention Type DRUG

Paclitaxel

administered intravenously

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Part C: Participant has histologically or cytologically confirmed, locally advanced, unresectable Stage III Non-small cell lung cancer (NSCLC) suitable for definitive chemoradiotherapy (CRT)

Part D: Participant with locally advanced, histologically confirmed inoperable esophageal squamous cell carcinoma (ESCC) suitable for definitive CRT

Phase 1b (Dose Expansion): Participants with histologically or cytologically confirmed solid tumors of selected types previously treated with standard therapy.
3. Participants must be able to provide formalin-fixed paraffin embedded (FFPE) tumor tissue sample.
4. Phase 1a Part A, A-CN, B and Phase 1b: ≥ 1 measurable lesion per Response evaluation criteria in solid tumors (RECIST) v1.1
5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1

Exclusion Criteria

1. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
2. Any malignancy ≤ 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent
3. Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before the first dose of study drug(s).
4. Clinically significant infection requiring systemic therapy ≤ 14 days before the first dose of study drug(s).
5. Prior exposure to agents with second mitochondria-derived activator of caspases (SMAC) mimetics, or other Inhibitors of apoptosis proteins (IAPs) antagonists.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BeiGene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Banner Md Anderson Cancer Center

Gilbert, Arizona, United States

Site Status

Florida Cancer Specialist (Scri) Sarasota

Sarasota, Florida, United States

Site Status

Scri Florida Cancer Specialists North

St. Petersburg, Florida, United States

Site Status

Scri Florida Cancer Specialist East

West Palm Beach, Florida, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Upmc Hillman Cancer Center(Univ of Pittsburgh)

Pittsburgh, Pennsylvania, United States

Site Status

Sanford Cancer Center

Sioux Falls, South Dakota, United States

Site Status

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Site Status

Tennessee Oncology, Pllc Nashville

Nashville, Tennessee, United States

Site Status

Mary Crowley Cancer Research

Dallas, Texas, United States

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

The University of Texas Md Anderson Cancer Center (Department Gi Medical Oncology)

Houston, Texas, United States

Site Status

Intermountain Healthcare

Salt Lake City, Utah, United States

Site Status

Next Virginia

Fairfax, Virginia, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Northern Beaches Hospital

Frenchs Forest, New South Wales, Australia

Site Status

Icon Cancer Centre South Brisbane

South Brisbane, Queensland, Australia

Site Status

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Site Status

Austin Health

Heidelberg, Victoria, Australia

Site Status

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia

Site Status

Sunshine Hospital

St Albans, Victoria, Australia

Site Status

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Site Status

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status

Hunan Cancer Hospital

Changsha, Hunan, China

Site Status

Shandong Provincial Hospital

Jinan, Shandong, China

Site Status

Shandong Cancer Hospital

Jinan, Shandong, China

Site Status

Auckland City Hospital

Auckland, , New Zealand

Site Status

National Cancer Center (Korea)

IlsandongGu GoyangSi, Gyeonggi-do, South Korea

Site Status

Gachon University Gil Medical Center

NamdongGu, Incheon Gwang'yeogsi, South Korea

Site Status

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, South Korea

Site Status

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea

Site Status

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, South Korea

Site Status

Countries

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United States Australia China New Zealand South Korea

Other Identifiers

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CTR20232532

Identifier Type: OTHER

Identifier Source: secondary_id

BGB-24714-101

Identifier Type: -

Identifier Source: org_study_id

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