Overview

Study Investigating BGB-24714 as Monotherapy and in Combination With Chemotherapy in Participants With Advanced or Metastatic Solid Tumors

Status:
Not yet recruiting
Trial end date:
2025-01-22
Target enrollment:
0
Participant gender:
All
Summary
This is an open-label, multicenter, and non-randomized Phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-24714 as monotherapy and in combination with chemotherapy in participants with advanced or metastatic solid tumors.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
BeiGene
Treatments:
Paclitaxel
Criteria
Key Eligibility Criteria:

1. Patient must sign a written informed consent form (ICF); and agree to comply with
study requirement.

2. Phase 1a (Dose Escalation): 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.

3. 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.

4. ≥ 1 measurable lesion per RECIST v1.1

5. ECOG Performance Status ≤ 1

6. Patient with adequate organ function

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. Any major surgical procedure ≤ 28 days before the first dose of study drug(s).

6. Prior exposure to agents with Smac mimetics, or other IAP antagonists.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.