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 (Jun 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
Treatments studied
Other
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 →Frequently asked questions
Is NCT06136884 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anticancer therapy, radiation therapy disqualifies patients from enrollment.
Does this trial require TP53?
Yes, TP53 mutation is a required biomarker for enrollment.
Does this trial require TP53?
Yes, TP53 loss is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV or III is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify