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Recruiting Phase 1, Phase 2 NCT05944224

A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients 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 63
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2023-10-17
Completion 2026-05-31
Interventions
SPH4336Cadonilimab

Brief Summary

This is a randomized, Open-label, Phase Ib/IIa study to evaluate the efficacy and safety of SPH4336 monotherapy or in combination with Cadonilimab in the patients with selected advanced solid tumors.

Eligibility Criteria

Inclusion Criteria: 1. Subjects voluntarily participate in this study and sign informed consent. 2. Expected survival ≥3 months. 3. Patients with advanced solid tumors (including advanced Well differentiated/dedifferentiated liposarcoma) who cannot be treated by radical surgery/other local treatment. 4. According to RECIST v1.1, participants in the dose expansion phase must have at least one measurable lesion. 5. The laboratory test results meet the organ function requirements before starting the study treatment. 6. Prior to the start of the study treatment, the peripheral nerve toxicity of previous anti-tumor drug treatment had returned to ≤ grade 2, and other reversible toxic reactions had returned to ≤ grade 1, but hair loss/pigmentation and other effects were assessed by the investigator as beneficial to the subjects receiving the study treatment. The toxicity of the risk is not subject to this limitation. 7. Subjects agree to use effective contraception from the time they sign the

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