Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Vincerx Pharma, Inc.
Study ID
NCT06034275
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VIP943 (QW) — DRUG
    VIP943 will be administered by IV Infusion weekly
  • VIP943 (BIW) — DRUG
    VIP943 will be administered by IV Infusion bi-weekly

Study Details

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

Key Dates

Start date
Sep 13, 2023
Status verified
Nov 2024
Primary completion
May 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation of VIP943 (QW)
    Subjects with AML, MDS, and B-ALL with CD123 expression will be administered VIP 943 in sequential ascending doses as a monotherapy via intravenous (IV) administration weekly (QW).
  • Experimental: Dose Escalation of VIP943 (BIW)
    Subjects with AML, MDS, and B-ALL with CD123 expression will be administered VIP 943 in sequential ascending doses as a monotherapy via intravenous (IV) administration twice weekly (BIW).

Primary Outcome Measure

Incidence of DLT (Dose limit toxicity) of VIP943 [ Time Frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Research Site
University of CincinnatiCincinnatiOhio45219
Research Site
TriStar Bone Marrow TransplantNashvilleTennessee37203
Research Site
MD Anderson Cancer CenterHoustonTexas77030
Research Site
Fred Hutchinson Cancer CenterSeattleWashington98109
Research Site

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University of Alabama at Birmingham· Birmingham, ALUniversity of Cincinnati· Cincinnati, OHTriStar Bone Marrow Transplant· Nashville, TNMD Anderson Cancer Center· Houston, TXFred Hutchinson Cancer Center· Seattle, WA

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