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

Sponsor:

Coiled Therapeutics

Sponsor Study ID:

A2A-O-004

CTO #:

104082

NCT Number:

NCT06136884

Phase:

I

Protocol Type:

Treatment

Age Group:

Adults

Disease Sites:

Breast; Other Female Genital; Ovary

Study Objectives:

The primary objectives are to determine the MTD/RP2D and safety profile of AO-252 in patients with advanced solid tumors. Secondary objectives:The secondary objectives are to: Determine antitumor activity of AO-252 as assessed by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), time to progression (TTP), and time to response (TTR)Determine the PK profile of AO-252 including maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), and area under the plasma concentration-time curve (AUC) over the dosing interval. Exploratory Objectives: The exploratory objectives are to: Determine antitumor activity of AO-252 as assessed by progression-free survival (PFS) and overall survival (OS). Evaluate the effect of AO-252 on clinically relevant tumor markers (phospho-histone H3, gammaH2AX, cleaved-PARP, TP53, TACC3, and CA levels).

eConsent:

Not available

Study Documents:

Open Study Documents
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