Testing T3011 for advanced melanoma treatment

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

This study is testing a new treatment called T3011 to see if it can help people with advanced melanoma feel better and manage their condition.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd (Industry-sponsored)
• Locations: 7 sites (Beijing and 6 other locations)
• Trial ID: NCT06214156 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the safety, tolerability, and preliminary effectiveness of T3011 in patients diagnosed with advanced melanoma. Participants must have at least one measurable lesion and meet specific health criteria to ensure they can safely undergo the treatment. The study is designed to gather data on how well T3011 works in this patient population and to monitor any side effects that may arise during the treatment process.

Who should consider this trial

Good fit: Ideal candidates are individuals with advanced melanoma who have at least one measurable lesion and meet the specified health criteria.

Not a fit: Patients who have recently received other antitumor therapies or have certain health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced melanoma.

How similar studies have performed: While there have been various studies on melanoma treatments, the specific approach with T3011 is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Subjects with advanced melanoma;
2. At least one measurable lesion;
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
4. Expected survival \> 12 weeks;
5. Laboratory inspection meets the requirements;
6. For women of childbearing potential, the serum pregnancy test results must be negative within 7 days prior to the first dose，and effective contraceptive measures must be taken from signing the informed consent form (ICF) until at least 6 months after the last dose;
7. Male subjects of childbearing potential agree to use effective contraception from signing the ICF until at least 6 months after the last dose; In addition, male subjects must agree not to donate sperm during this period;
8. Understand and voluntarily sign the ICF，willing and able to comply with all experimental requirements.

Exclusion Criteria:

1. Subjects who have received other antitumor therapy within the prescribed time prior to the first dose;
2. Subjects with a history of other malignancies within the prescribed time prior to the start of study treatment.
3. At screening, subjects with a history or evidence of high risk cardiovascular disease;
4. Subjects with persistent or active infection requiring intravenous anti-infective therapy;
5. Subjects with autoimmune diseases or a history of autoimmune diseases;
6. Subjects with known psychiatric disorders that may affect trial compliance;
7. Subjects who have pleural effusion, pericardial effusion, or ascites before starting treatment and require puncture drainage, or who had received puncture drainage within the specified time before starting the study treatment;
8. Subjects requiring systemic treatment with anti-HSV drugs during the study period;
9. Subjects who have received live or attenuated vaccines within the prescribed time prior to the first dose, or who plan to receive such vaccines during the study period; Subjects who have received any tumor vaccine in the past;
10. Subjects who had undergone major surgery within the prescribed time before the first dose，and had not recovered from surgery-related adverse reactions or were still in the postoperative recovery period，or who plan to undergo major surgery during the study period;
11. Subjects with a history of drug use，drug abuse or alcohol abuse within the year prior to signing the ICF;
12. Female subjects who are pregnant or breastfeeding, or planning to conceive or have children during the study period;
13. The investigator considers it inappropriate to participate in this study.

Where this trial is running

Beijing and 6 other locations

• Beijing Cancer Hospital — Beijing, China (Recruiting)
• The First Affiliated Hospital of Bengbu Medical College — Bengbu, China (Recruiting)
• Jilin Cancer Hospital — Changchun, China (Recruiting)
• Chengdu Shangjin Nanfu Hospital — Chengdu, China (Recruiting)
• Fujian Cancer Hospital — Fuzhou, China (Recruiting)
• The Third People's Hospital of Zhengzhou — Zhengzhou, China (Recruiting)
• Sun Yat-sen University Cancer Center — Zhongshan, China (Recruiting)

Study contacts

• Study coordinator: Jun Guo

Conditions Advanced Melanoma