RecruitingPhase 1Phase 2NCT06848699

A Phase Ib/II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Patients With Advanced/Metastatic Solid Tumors

A Phase Ib/ II Clinical Study to Evaluate the Safety ,Torlerbility , and Efficacy of HLX43 (Anti-PD-L1 ADC) in Combination With Serplulimab (Anti-PD-1 Humanized Monocl ) in Patients With Advanced/Metastatic Solid Tumors


Sponsor

Shanghai Henlius Biotech

Enrollment

105 participants

Start Date

Feb 25, 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 combination with Serplulimab (anti-PD-1 humanized monoclonal antibody injection) in patients with advanced/metastatic solid tumors


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new experimental drug called HLX43 in combination with an immunotherapy drug called serplulimab for people with advanced or metastatic solid tumors (cancers in organs or tissues) that have not responded to standard treatments. **You may be eligible if...** - You are between 18 and 75 years old - You have a confirmed advanced or metastatic solid tumor - Standard treatment options have been exhausted or are no longer working - Your general health is adequate to participate (as assessed by your doctor) - You are willing and able to follow all study procedures **You may NOT be eligible if...** - You have significant heart, liver, or kidney problems - You have active autoimmune disease or are on immune-suppressing medications - You have untreated brain metastases - You have received recent immunotherapy that caused serious side effects - You are pregnant or breastfeeding 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 dose 1

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.

DRUGHLX43 dose 2

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.

DRUGHLX43 dose 3

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.

DRUGHLX43 dose 4

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.

DRUGHLX43 dose 5

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.

DRUGSerplulimab

anti-PD-1 humanized monoclonal antibody injection


Locations(3)

Hunan Provincial Cancer Hospital

Hunan, Changsha, China

Shandong Cancer Hospital

Jinan, Shangdong, China

Second Affiliated Hospital of Army Medical University, PLA

Chongqing, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06848699


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