RecruitingPhase 2NCT06081920

A Study of IBI363 in Subjects With Advanced Melanoma

A Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of IBI363 in Subjects With Advanced Melanoma


Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Enrollment

150 participants

Start Date

Oct 19, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-lable, multicenter Phase II study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced melanoma patients


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called IBI363 in people with advanced melanoma (skin cancer that has spread and cannot be surgically removed) whose cancer has continued growing after prior treatment. IBI363 is designed to block certain proteins that allow cancer to hide from the immune system. **You may be eligible if...** - You have been diagnosed with unresectable, locally advanced or metastatic melanoma (stage III or IV) - Your cancer has progressed after at least one prior systemic treatment - You have at least one measurable tumor - You have good overall health (ECOG 0 or 1) - Your life expectancy is at least 3 months - Women and male partners of childbearing potential agree to use effective contraception **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have active or symptomatic brain metastases - Your blood counts, liver function, or kidney function are significantly abnormal - You have a clotting disorder or recent history of blood clots - You have uncontrolled bleeding or a known bleeding tendency 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

BIOLOGICALIBI363

IBI363 monotherapy


Locations(12)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Peking University Cancer Hospital & Institute, Beijing, China,

Beijing, Beijing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

The Third people's hospital of Zhengzhou

Zhengzhou, Henan, China

Hunan Cancer Hospital

Changsha, Hunan, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

The first affiliated hospital of Nanchang university

Nanchang, Jiangxi, China

Jilin Cancer Hospital

Changchun, Jilin, China

The first hospital of Jilin University

Changchun, Jilin, China

Qilu Hospital of Shandong university

Jinan, Shandong, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Yunan Cancer Hospital

Kunming, Yunan, China

View Full Details on ClinicalTrials.gov

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

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NCT06081920


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