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Recruiting Phase 1, Phase 2 NCT06214156

A Clinical Study of T3011 in Subjects With Advanced Melanoma

Trial Parameters

Condition Advanced Melanoma
Sponsor Shanghai Pharmaceuticals Holding Co., Ltd
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 42
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-01-26
Completion 2026-09-30
Interventions
T3011

Brief Summary

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

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

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