MedTrace Logo

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

NCT07639450 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2026-07-08

No results posted yet for this study

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.

Conditions

  • Advanced Malignant Solid Tumors

Interventions

DRUG

N-3C01(Q2W)

subcutaneous injection once every 2 weeks

DRUG

N-3C01(Q3W)

subcutaneous injection once every 3 weeks

DRUG

N-3C01

subcutaneous injection once every 2 or 3 weeks.

DRUG

Pembrolizumab

intravenous injection once every 3 weeks

Sponsors & Collaborators

  • Hefei Xinzhu Biological Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2028-08-31
Completion
2028-09-30

Countries

  • Australia
  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07639450 on ClinicalTrials.gov