Trials / Terminated
TerminatedNCT05252416
(VELA) Study of BLU-222 in Advanced Solid Tumors
A Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of BLU-222 as a Single Agent and in Combination Therapy for Patients With Advanced Solid Tumors
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Blueprint Medicines Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | BLU-222 | Oral administration |
| DRUG | Carboplatin | IV Infusion |
| DRUG | Ribociclib | Oral administration |
| DRUG | Fulvestrant | Intra muscular administration |
Timeline
- Start date
- 2022-04-07
- Primary completion
- 2025-07-04
- Completion
- 2025-07-04
- First posted
- 2022-02-23
- Last updated
- 2025-11-28
Locations
23 sites across 3 countries: United States, Italy, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05252416. Inclusion in this directory is not an endorsement.