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

Phase 1TerminatedNCT05381909

BeiGene157 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

157

Conditions

Solid Tumor, Adult

Interventions

BGB-24714DRUG

administered orally

PaclitaxelDRUG

administered intravenously

CarboplatinDRUG

administered intravenously

Docetaxel

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Eligibility Criteria : 1. Participants must sign a written informed consent form (ICF); and agree to comply with study requirement 2. Phase 1a (Dose Escalation): Part A, A-CN, and B: Participants 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 Note: Only Chinese participants will be eligible for Part A-CN. 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 Key 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. NOTE: Other protocol defined inclusion/exclusion criteria may apply.

Locations (34)

Outcomes

Primary Outcomes

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

Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs ), and experiencing AEs meeting protocol defined Dose-Limiting Toxicity (DLT) criteria.

Time frame: approximately 6 months

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

Time frame: approximately 6 months

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

Recommended dose based upon the MTD or MAD, as well as the long-term tolerability, pharmacokinetics, efficacy, and any other relevant data as available

Time frame: approximately 6 months

Dose Expansion: Objective response rate (ORR)

ORR is defined as the percentage of participants with partial or complete response, as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Time frame: approximately 2 Years

Secondary Outcomes

Dose Escalation: Objective response rate (ORR)

ORR is defined as the percentage of participants with partial or complete response, as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Time frame: approximately 2 Years

Dose Expansion: Progression-free Survival (PFS)

PFS is defined as the time from the date of the first dose of study drug to the date of first documentation of disease progression as determined by the investigator using RECIST v1.1 or death, whichever occurs first

Data from ClinicalTrials.gov

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administered intravenously

Banner Md Anderson Cancer Center

Gilbert, Arizona, United States

Florida Cancer Specialist (Scri) Sarasota

Sarasota, Florida, United States

Scri Florida Cancer Specialists North

St. Petersburg, Florida, United States

Scri Florida Cancer Specialist East

West Palm Beach, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Upmc Hillman Cancer Center(Univ of Pittsburgh)

Pittsburgh, Pennsylvania, United States

Sanford Cancer Center

Sioux Falls, South Dakota, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

...and 24 more locations

Time frame: approximately 2 Years

Dose Expansion: Number of participants with adverse events

Number of participants with AEs and SAEs

Time frame: approximately 2 Years

Duration of Response (DOR)

DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Time frame: approximately 2 Years

Disease Control Rate (DCR)

DCR is defined as the percentage of participants whose best overall response is complete response, partial response, or stable disease, as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Time frame: approximately 2 Years

Clinical Benefit Rate (CBR)

CBR is defined as the percentage of participants who have complete response, partial response, and stable disease, as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Time frame: approximately 2 Years

Plasma Concentrations of BGB-24714 and its metabolite

Time frame: approximately 2 Years

Maximum Observed Plasma Concentration (Cmax) of BGB-24714 and its metabolite