N-3C01 Monotherapy and Combination With PD-(L)1 Inhibitors in Advanced Solid Tumors

Recruiting Phase 1 Phase 2 Interventional Study
Advanced Malignant Solid Tumors
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
114 (estimated)
Sponsor
Hefei Xinzhu Biological Technology Co., Ltd. · Industry
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About This Trial

This Phase I/II study evaluates the safety, tolerability, and efficacy of N-3C01 administered subcutaneously, both as monotherapy and in combination with a PD-(L)1 monoclonal antibody, in patients with advanced solid tumors. Phase I involves dose escalation for both monotherapy and combination therapy, while Phase II includes cohort expansion for the combination therapy.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Willingness to voluntarily participate in the study and provide written informed consent. 2. Age 18 to 75 years (inclusive) at the time of signing the informed consent form, regardless of gender. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (refer…
Contacts

Karen Zhou

+8613521345200

Karen.zhou@novotech-cro.com

CONTACT