A First-In-Human, Phase 1 Study Evaluating Oral TACC3 PPI Inhibitor, AO-252, in Advanced Solid Tumors With or Without Brain Metastases

Part of paid clinical trials in Detroit, Michigan.

Sponsor
A2A Pharmaceuticals Inc.
Study ID
NCT06136884
Phase
PHASE1
Status
Recruiting

Conditions

  • Brain Metastases From Solid Tumors
  • Solid Tumor Malignancies

Eligibility Criteria

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

Interventions

  • AO-252 — DRUG
    AO-252 will be administered oral tablets or capsules daily

Study Details

The purpose of this study is to assess the safety, tolerability and efficacy of the study drug AO-252 and identify the best dose for use in future studies.

Key Dates

Start date
Nov 2, 2023
Status verified
Sep 2025
Primary completion
Jan 28, 2027
Completion
Jan 27, 2028

Study Design

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

Arms

  • Experimental: Part 1: Dose Escalation
    Participants will be assigned to dose levels.
  • Experimental: Part 2: Dose Expansion
    After doses are decided in Part 1, participants entering part 2 will be assigned to a dose level.

Primary Outcome Measure

Safety Assessments [Dose escalation] [ Time Frame: 12 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Karmanos Cancer InstituteDetroitMichigan48201
Ira Winer, MD (PRINCIPAL_INVESTIGATOR)
Oklahoma UniveristyOklahoma CityOklahoma73104
Christina Caldwell
405-271-8001
Mary Crowley Cancer ResearchDallasTexas75230
Angela Hotchkiss
Mina Barve, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas M.D. Anderson Cancer CenterHoustonTexas77030
Amber Kennon
Next Oncology -VirginiaFairfaxVirginia22031
Anthony Young
Alexander Spira, MD (PRINCIPAL_INVESTIGATOR)

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