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AST-001 in Advanced Solid Tumors
NCT06245330Phase 2
Key facts
- Status
- Recruiting
- Start
- Jul 2022
- Primary completion
- Aug 2027
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- Threonine
- Conditions
- solid tumorpancreatic cancer (PC)
01
Overview
Phase 2, open-label trial of Threonine in solid tumor and pancreatic cancer (PC) (2 arms), sponsored by Ascentawits Pharmaceuticals Ltd. Primary endpoints: Incidence and severity of adverse events, Assess safety changes in electrocardiogram and 8 more. Started Jul 2022; status: recruiting.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Dose Escalation
AST-001 5.0-40.0 mg/m^2 IV (Days 1, 8, 15 q4w)
Phase II Pancreatic Cancer
AST-001 RP2D IV (Days 1, 8, 15 q4w)
03
Who it enrols
Adults aged 18-70 with advanced solid tumors (Phase I) or AKR1C3-positive pancreatic cancer (Phase II), ECOG PS 0-1, and adequate organ function. Excludes patients with recent prior malignancies, uncontrolled infections, or significant cardiac disease.
04
Endpoints
Primary
Incidence and severity of adverse events
Assess safety changes in electrocardiogram
Assess safety changes of body weight
Number of participants with dose limiting toxicities
Define the Recommended Phase 2 Dose
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