OncoMatch/Clinical Trials/NCT06136884
A First-In-Human, Phase 1 Study Evaluating Oral TACC3 PPI Inhibitor, AO-252, in Advanced Solid Tumors With or Without Brain Metastases
Is NCT06136884 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies AO-252 for solid tumor malignancies.
Treatment: AO-252 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Required: TP53 mutation
solid tumors with TP53 mutation/loss
Required: TP53 loss
solid tumors with TP53 mutation/loss
Disease stage
Required: Stage IV, III
Metastatic disease required
metastatic or locally advanced unresectable solid tumors
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — metastatic
Patients must have relapsed/be refractory to at least 1 line of systemic therapy in the metastatic setting
Must have received: androgen receptor-targeted therapy (abiraterone acetate, apalutamide, enzalutamide, darolutamide)
Patients who progressed on at least 1 prior novel androgen receptor AR-targeted therapy (that is, abiraterone acetate, apalutamide, enzalutamide, darolutamide)
Must have received: systemic chemotherapy (docetaxel)
and or at least 1 prior systemic chemotherapy (e.g., docetaxel)
Cannot have received: systemic anticancer therapy
Patient has received systemic anticancer therapy within 3 weeks or 5 half-lives, whichever is shorter.
Cannot have received: radiation therapy
Radiation therapy to > 30% of bone marrow within 3 months before study entry.
Lab requirements
Blood counts
ANC ≥ 1,500/mm3; Platelet count ≥ 100,000/mm3; Hemoglobin ≥ 9 g/dL
Kidney function
Creatinine clearance ≥ 60 mL/min (by Cockroft Gault formula)
Liver function
Bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels >1.5 × ULN; ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN if liver metastases are present)
Cardiac function
Adequate cardiac function; abnormal or clinically significant ECG abnormality, including but not limited to a confirmed QTcF > 470 msec [excluded]
Adequate bone marrow reserve, cardiac, liver, and renal function: ANC ≥ 1,500/mm3; Platelet count ≥ 100,000/mm3; Hemoglobin ≥ 9 g/dL; Bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels >1.5 × ULN; ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN if liver metastases are present); Creatinine clearance ≥ 60 mL/min (by Cockroft Gault formula); abnormal or clinically significant ECG abnormality, including but not limited to a confirmed QTcF > 470 msec [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Karmanos Cancer Institute · Detroit, Michigan
- Oklahoma Univeristy · Oklahoma City, Oklahoma
- Mary Crowley Cancer Research · Dallas, Texas
- The University of Texas M.D. Anderson Cancer Center · Houston, Texas
- Next Oncology -Virginia · Fairfax, Virginia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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