RecruitingPhase 1Phase 2NCT07639450

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

A Phase I/II Clinical Study Evaluating the Safety, Tolerability, and Efficacy of N-3C01 as Monotherapy and in Combination With PD-(L)1 Monoclonal Antibody in Patients With Advanced Malignant Solid Tumors


Sponsor

Hefei Xinzhu Biological Technology Co., Ltd.

Enrollment

114 participants

Start Date

Jun 15, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called N-3C01, a drug called N-3C01(Q2W), and others for people with advanced malignant solid tumors. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGN-3C01(Q2W)

subcutaneous injection once every 2 weeks

DRUGN-3C01(Q3W)

subcutaneous injection once every 3 weeks

DRUGN-3C01

subcutaneous injection once every 2 or 3 weeks.

DRUGPembrolizumab

intravenous injection once every 3 weeks


Locations(6)

GenesisCare Research

Saint Leonards, New South Wales, Australia

San Clinical Trials Unit

Wahroonga, New South Wales, Australia

Corner Edith & Platt Streets, , NSW 2298 Australia

Waratah, New South Wales, Australia

Hunan Cancer Hospital

Changsha, Hunan, China

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Henan Cancer Hospital

Zhengzhou, Zhengzhou, China

View Full Details on ClinicalTrials.gov

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NCT07639450


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