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 — DRUGAO-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 EscalationParticipants will be assigned to dose levels.
- Experimental: Part 2: Dose ExpansionAfter 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
- Robbin Frnka, Chief ClinOps Officer2142055746
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | Ira Winer, MD (PRINCIPAL_INVESTIGATOR) |
| Oklahoma Univeristy | Oklahoma City | Oklahoma | 73104 | |
| Mary Crowley Cancer Research | Dallas | Texas | 75230 | Angela Hotchkiss Mina Barve, MD (PRINCIPAL_INVESTIGATOR) |
| The University of Texas M.D. Anderson Cancer Center | Houston | Texas | 77030 | Guoxin Feng Amber Kennon |
| Next Oncology -Virginia | Fairfax | Virginia | 22031 | Anthony Young Alexander Spira, MD (PRINCIPAL_INVESTIGATOR) |
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