A Phase 1, Open-Label, Dose-escalation and Dose-Expansion Study Evaluating AO-252, a Protein-Protein Interaction Inhibitor of TACC3, in Patients With Advanced Solid Tumors With or Without Brain Metastases
A2A Pharmaceuticals Inc.
Summary
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.
Description
The purpose of this study is to characterize the safety, tolerability including determination of maximum tolerated dose (MTD), and identify the recommended Phase 2 dose (RP2D). The study will also look at pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumor activity of AO-252 as a monotherapy in participants with advanced solid tumors with or without brain mestastases.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adults ≥ 18 years of age. 2. Patient has histologically or cytologically confirmed metastatic or locally advanced unresectable solid tumors with TP53 mutation/loss and with/without brain metastasis. Patients must have relapsed/be refractory to at least 1 line of systemic therapy in the metastatic setting (excluding melanoma). 3. Prostate cancer: 1. mCRPC with histologic confirmation of adenocarcinoma. mCRPC with neuroendocrine features or mixed histology are excluded 2. Patients will be enrolled irrespective of the TP53 status 3. Participant must have prostate…
Interventions
- DrugAO-252
AO-252 will be administered oral tablets or capsules daily
Locations (5)
- Karmanos Cancer InstituteDetroit, Michigan
- Oklahoma UniveristyOklahoma City, Oklahoma
- Mary Crowley Cancer ResearchDallas, Texas
- The University of Texas M.D. Anderson Cancer CenterHouston, Texas
- Next Oncology -VirginiaFairfax, Virginia