RecruitingPhase 1Phase 2NCT06214156

A Clinical Study of T3011 in Subjects With Advanced Melanoma

A Phase Ib/IIa Clinical Study to Evaluate the Tolerability, Safety and Preliminary Efficacy of T3011 in Subjects With Advanced Melanoma


Sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Enrollment

42 participants

Start Date

Jan 26, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical study evaluated the tolerability, safety and preliminary efficacy of T3011 in subjects with advanced melanoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing T3011, an experimental cancer drug, in people with advanced melanoma (skin cancer that has spread). T3011 is a type of modified oncolytic virus — a specially engineered virus that selectively infects and destroys cancer cells while also activating the immune system to attack the tumor. **You may be eligible if...** - You have been diagnosed with advanced melanoma - You have at least one tumor that can be measured - You are in reasonably good physical health and able to carry out daily activities - Your expected survival is more than 12 weeks - Women of childbearing age must have a negative pregnancy test and use contraception during and for 6 months after the study - Male participants must also use contraception and not donate sperm during this period **You may NOT be eligible if...** - You have received certain other cancer treatments too recently before enrollment - You have had another cancer diagnosis within a certain time period - You have significant heart problems or cardiovascular disease - You have an active infection requiring IV antibiotics - You have an autoimmune disease or a history of one - You have fluid buildup around your lungs, heart, or abdomen (pleural, pericardial effusion, or ascites) - You have significant psychiatric conditions that may affect your ability to participate 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

BIOLOGICALT3011

T3011 will be given intratumorally, Q2W;


Locations(7)

Beijing Cancer Hospital

Beijing, China

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

Jilin Cancer Hospital

Changchun, China

Chengdu Shangjin Nanfu Hospital

Chengdu, China

Fujian Cancer Hospital

Fuzhou, China

The Third People's Hospital of Zhengzhou

Zhengzhou, China

Sun Yat-sen University Cancer Center

Zhongshan, China

View Full Details on ClinicalTrials.gov

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NCT06214156


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