RecruitingPhase 2NCT06769152

A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Advanced Gynecological Malignant Tumors

A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Recurrent/Metastatic Gynecological Malignant Tumors Failed or Intolerance to Standard First-Line Therapy


Sponsor

Shanghai Henlius Biotech

Enrollment

190 participants

Start Date

Feb 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in patients with recurrent/metastatic cervical cancer or ovarian cancer failed or intolerance to standard first-line therapy.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing HLX43 — a new drug that delivers chemotherapy directly to cancer cells by attaching to PD-L1, a protein overexpressed in many cancers — in women with advanced gynecological cancers including cervical cancer and ovarian cancer that have progressed after standard treatment. **You may be eligible if...** - You are between 18 and 75 years old - For Cohort 1: You have metastatic or recurrent cervical cancer (squamous, adenocarcinoma, or adenosquamous type) that has progressed on or after standard therapy including platinum-based chemotherapy and immunotherapy (if PD-L1 positive) - For Cohort 2: You have confirmed high-grade serous ovarian, fallopian tube, or primary peritoneal cancer that has progressed after platinum-based therapy - Your cancer has progressed on or after standard treatment **You may NOT be eligible if...** - Your organ function is inadequate to tolerate this treatment - You have active brain metastases or uncontrolled systemic illness - You have had severe prior reactions to similar antibody-drug conjugate therapy - You have serious autoimmune conditions 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

DRUGHLX43

HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.


Locations(1)

Shandong Cancer Hospital

Ji'nan, Shandong, China

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NCT06769152


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