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

BeiGene

Status and phase: Active, not recruiting; Phase 1

Conditions: Solid Tumor, Adult

Treatments: Drug: BGB-24714; Drug: Paclitaxel; Drug: Carboplatin; Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT05381909

BGB-24714-101

CTR20232532 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 157 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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157 participants in 7 patient groups

Phase 1a: Dose Escalation Part A

Experimental group

Description:

Participants will receive escalating doses of BGB-24714 as monotherapy

Treatment:

Drug: BGB-24714

Phase 1a: Dose Escalation Part B

Experimental group

Description:

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

Treatment:

Drug: Paclitaxel

Drug: BGB-24714

Phase 1a: Dose Escalation Part C

Experimental group

Description:

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

Treatment:

Drug: Carboplatin

Drug: Paclitaxel

Drug: BGB-24714

Phase 1a: Dose Escalation Part D

Experimental group

Description:

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

Treatment:

Drug: Carboplatin

Drug: Paclitaxel

Drug: BGB-24714

Phase 1a: Dose Escalation Part A-CN

Experimental group

Description:

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

Treatment:

Drug: BGB-24714

Phase 1a: Dose Escalation Part E

Experimental group

Description:

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

Treatment:

Drug: Carboplatin

Drug: Paclitaxel

Drug: BGB-24714

Phase 1b: Dose Expansion

Experimental group

Description:

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

Treatment:

Drug: Docetaxel

Drug: Paclitaxel

Drug: BGB-24714