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Clinical Trial Summary

This is a platform study evaluating the safety and efficacy of multiple novel investigational products (IPs) that target unresectable or metastatic cutaneous melanoma in participants who have failed standard treatment.


Clinical Trial Description

This is a Phase 1b/2, randomized, open label, multicenter, platform study evaluating the safety and efficacy of multiple novel investigational products (IPs) that target mechanisms implicated in resistance to immunotherapy in participants with unresectable or metastatic cutaneous melanoma who have resistance to anti-PD-1/L1 agents. This study will include multiple treatment arms that can be added sequentially or in parallel. Each arm consists of a selection and expansion part. The selection part is used for evaluation of safety and preliminary efficacy in each arm. The selection part may also include a safety run-in portion for preliminary safety evaluation and dose confirmation prior to proceeding. If the criteria for safety and preliminary efficacy are met, the arm will open for additional enrollment in an expansion phase. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05572463
Study type Interventional
Source Innovent Biologics (Suzhou) Co. Ltd.
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date November 1, 2022
Completion date December 31, 2027

See also
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