Trials / Recruiting
RecruitingNCT06034275
Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies
An Open-label, Multicenter Phase 1 Study to Characterize Safety, Tolerability, Preliminary Antitumor Activity, Pharmacokinetics, and Pharmacodynamics of VIP943 Monotherapy in Subjects With Advanced CD123+ Hematologic Malignancies
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- Vincerx Pharma, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Dose Escalation - Determine the maximum tolerated dose (MTD), if possible, or minimum optimal biologic dose (OBD), and evaluate the safety and tolerability of VIP943 in subjects with advanced CD123+ hematologic malignancies
Detailed description
Relapsed or refractory AML, MDS, or B-ALL subjects who are CD123 positive. Subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VIP943 (QW) | VIP943 will be administered by IV Infusion weekly |
| DRUG | VIP943 (BIW) | VIP943 will be administered by IV Infusion bi-weekly |
Timeline
- Start date
- 2023-09-13
- Primary completion
- 2025-05-30
- Completion
- 2025-12-31
- First posted
- 2023-09-13
- Last updated
- 2024-11-15
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06034275. Inclusion in this directory is not an endorsement.