RecruitingPhase 1Phase 2NCT06245330

A Phase I/II Study of AST-001 in Subjects With Advanced Solid Tumors

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy and Correlation With AKR1C3 Enzyme Expression of AST-001 in Subjects With Advanced Solid Tumors


Sponsor

Ascentawits Pharmaceuticals, Ltd

Enrollment

180 participants

Start Date

Jul 7, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

A first-in-human open-label, Phase I/II study to evaluate the safety, tolerability, MTD/RP2D, PK, and preliminary efficacy of AST-001 administered as a single agent.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new drug called AST-001 in people with advanced solid tumors (cancers that form solid masses) that have spread or cannot be surgically removed and for which standard treatments are no longer working. The initial phase focuses on finding the safest dose, followed by testing effectiveness. **You may be eligible if...** - You are between 18 and 70 years old - You have a confirmed advanced solid tumor for which standard curative treatments no longer exist or are not effective - Your general health is good (ECOG performance status 0 or 1) - Your life expectancy is at least 12 weeks - Your liver, kidneys, and bone marrow are functioning adequately - Side effects from prior cancer treatments have largely resolved **You may NOT be eligible if...** - You have had another primary cancer in the past 2 years (with some exceptions like treated skin cancer) - You have active or untreated brain metastases - You have serious heart problems or uncontrolled infections - You are pregnant or breastfeeding - You have had prior treatment with a similar type of drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAST-001

liquid formulation for Intravenous infusion


Locations(1)

Jinlin Cancer Hospital

Changchun, Jinlin, China

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NCT06245330


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