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Recruiting Phase 1, Phase 2 NCT06214143

A Clinical Study of T3011 in Combination With PD-1/PD-L1 Inhibitors in Subjects With Advanced Solid Tumors

Trial Parameters

Condition Advanced Solid Tumors
Sponsor Shanghai Pharmaceuticals Holding Co., Ltd
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 68
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-01-11
Completion 2025-12-31
Interventions
T3011 high doseT3011 middle doseT3011 low dose

Brief Summary

This clinical study evaluated the efficacy and safety of T3011 in combination with PD-1/PD-L1 inhibitors in subjects with advanced solid tumors

Eligibility Criteria

Inclusion Criteria: 1. Subjects with advanced solid tumors; 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 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 mal

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