(VELA) Study of BLU-222 in Advanced Solid Tumors
NCT05252416 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2025-11-28
Summary
This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anticancer activity of BLU-222, a selective inhibitor of CDK2.
Conditions
- Advanced Solid Tumors
- HR+ Breast Cancer
- CCNE1 Amplification
- HER2-negative Breast Cancer
- Ovarian Cancer
- Endometrial Cancer
- Gastric Cancer
- Esophageal Adenocarcinoma
- Carcinosarcoma
Interventions
- DRUG
-
BLU-222
Oral administration
- DRUG
-
IV Infusion
- DRUG
-
Oral administration
- DRUG
-
Intra muscular administration
Sponsors & Collaborators
-
Blueprint Medicines Corporation
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-07
- Primary Completion
- 2025-07-04
- Completion
- 2025-07-04
- FDA Drug
- Yes
Countries
- United States
- Italy
- United Kingdom
Study Locations
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