RecruitingPhase 1Phase 2NCT06238687

A Study of STRO-002 in Chinese Adults With Epithelial Ovarian Cancer and Other Advanced Malignant Solid Tumors

A Phase I/IIa Study to Evaluate the Safety, Tolerability , Pharmacokinetics and Preliminary Efficacy of STRO-002 in Chinese Adults With Advanced Epithelial Ovarian Cancer, Endometrial Cancer, and Other Advanced Malignant Solid Tumors.


Sponsor

Tasly Pharmaceutical Group Co., Ltd

Enrollment

132 participants

Start Date

Nov 8, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multi-center, open-label, monotherapy dose escalation, PK bridging, and dose expansion Phase I/IIa study in Chinese adult subjects to evaluate the safety, tolerability, Pharmacokinetics (PK) profiles, immunogenicity, and preliminary efficacy of STRO-002 in patients with advanced malignant solid tumors.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called STRO-002 in adults in China who have advanced ovarian cancer or other solid tumors that have returned or worsened after prior treatment. STRO-002 is an antibody-drug conjugate — a targeted therapy that delivers a toxic payload directly to cancer cells. **You may be eligible if...** - You have advanced solid tumor cancer (ovarian, fallopian tube, primary peritoneal, or endometrial cancer for dose expansion cohorts) - You have at least one measurable tumor on scans - You have received prior standard treatment and your cancer has returned or progressed - Your organs (heart, kidneys, liver, bone marrow) are functioning adequately - Your life expectancy is more than 3 months **You may NOT be eligible if...** - You have significant heart rhythm abnormalities (prolonged QT interval) - You have not recovered from side effects of prior cancer treatments - You have had no prior standard treatment when it is available - You do not have measurable disease on scans 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

BIOLOGICALSTRO-002

STRO-002 is an Antibody-drug conjugates (ADCs) combine the specificity of monoclonal antibodies with the anti-tumor activity of cytotoxic drugs.


Locations(1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

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NCT06238687


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