Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT07327632

This is a Multi-Center Study of IBI3026 in Participants With Locally Advanced, Unresectable or Metastatic Solid Tumors

Led by Innovent Biologics Technology Limited (Shanghai R&D Center) · Updated on 2026-02-04

300

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a multicenter, open-label, phase I dose-escalation and expansion study of IBI3026 in participants with unresectable, locally advanced, or metastatic solid tumors. The study will be conducted in two phases: Phase 1 dose escalation and Phase 2 dose expansion. Safety will be monitored by the Safety Review Committee (SRC).

CONDITIONS

Official Title

This is a Multi-Center Study of IBI3026 in Participants With Locally Advanced, Unresectable or Metastatic Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand and sign informed consent for all study procedures
  • Male or female aged 18 years or older
  • At least one measurable lesion per RECIST v1.1 within 28 days before first dose
  • ECOG performance status of 0 or 1
  • Life expectancy of at least 12 weeks at treatment start
  • Good bone marrow and organ function confirmed during screening
  • Non-reproductive potential or agreement to use effective contraception during study and for 6 months post-treatment
  • Not suitable for curative surgery or definitive chemoradiotherapy
Not Eligible

You will not qualify if you...

  • Prior treatment with IL-12 cytokines or IL-12 inhibitors
  • Participation in other interventional clinical studies or in follow-up of such studies
  • Unresolved adverse reactions from prior anti-tumor therapies above Grade 1 (except certain exceptions)
  • Severe adverse reactions from prior immune checkpoint inhibitor therapy compromising safety
  • Known allergy or intolerance to IBI3026 or its ingredients
  • Major surgery within 4 weeks before first dose or planned during study, excluding core biopsy
  • Serious non-healing wounds, trauma, or ulcers
  • Symptomatic central nervous system metastases; asymptomatic allowed if stable and meeting criteria
  • Tumor invading critical nearby structures or risk of gastrointestinal/respiratory fistula formation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sichuan Cancer Hospital

Chengdu, Sichuan, China, 610041

Actively Recruiting

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Research Team

H

Haiyun Zuo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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