Actively Recruiting
A Phase Ib/IIa Clinical Study to Evaluate the Tolerability, Safety and Preliminary Efficacy of T3011 in Subjects With Advanced Melanoma
Led by Shanghai Pharmaceuticals Holding Co., Ltd · Updated on 2026-01-14
42
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new biological treatment called T3011 for people with advanced melanoma, a serious form of skin cancer. This clinical trial is designed to assess how well patients tolerate T3011, its safety, and its early effects on the disease. The study is sponsored by Shanghai Pharmaceuticals Holding Co., Ltd and includes patients with measurable tumors and good overall health status. Participants will receive T3011 administered directly into the tumor every two weeks. The study is conducted in phases 1b and 2a to carefully monitor treatment effects and safety. There are no placebo or comparison groups mentioned, and the treatment schedule is consistent throughout the study period. During the trial, participants will undergo regular assessments to monitor side effects and treatment response, including measures like the objective response rate and disease control rate over approximately two years. Researchers will also track progression-free survival and overall survival. Safety evaluations and laboratory tests will be performed throughout, and participants must comply with contraception requirements if applicable. The total participation time is about two years, including follow-up for treatment outcomes.
CONDITIONS
Brief Title
A Clinical Study of T3011 in Subjects With Advanced Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have advanced melanoma
- Have at least one measurable tumor
- Have an ECOG performance status of 0 or 1
- Expected to live longer than 12 weeks
- Meet laboratory test requirements
- Women of childbearing potential must have a negative pregnancy test within 7 days before the first dose and agree to use effective contraception until 6 months after last dose
- Men of childbearing potential must agree to use effective contraception until 6 months after last dose and not donate sperm during this period
- Understand and voluntarily sign informed consent and agree to follow study requirements
You will not qualify if you...
- Received other antitumor therapy within the prescribed time before the first dose
- History of other cancers within the prescribed time before study treatment
- History or evidence of high-risk cardiovascular disease at screening
- Active infection needing intravenous antibiotics
- Autoimmune diseases or history of autoimmune diseases
- Known psychiatric disorders affecting compliance
- Have pleural, pericardial effusion, or ascites requiring drainage or had drainage recently
- Need systemic anti-HSV treatment during the study
- Received live or attenuated vaccines recently or plan to during study; previously received tumor vaccines
- Major surgery recently without full recovery or plan for major surgery during study
- History of drug or alcohol abuse within one year before consent
- Pregnant, breastfeeding, or planning pregnancy or children during study
- Investigator considers participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 2 years
Participants receive T3011 given intratumorally every 2 weeks.
Visits every 2 weeks for T3011 administration
Trial Site Locations
Total: 7 locations
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
2
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
Actively Recruiting
3
Jilin Cancer Hospital
Changchun, China
Actively Recruiting
4
Chengdu Shangjin Nanfu Hospital
Chengdu, China
Actively Recruiting
5
Fujian Cancer Hospital
Fuzhou, China
Actively Recruiting
6
The Third People's Hospital of Zhengzhou
Zhengzhou, China
Actively Recruiting
7
Sun Yat-sen University Cancer Center
Zhongshan, China
Actively Recruiting
Research Team
J
Jun Guo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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