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A First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors

NCT05458219 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 470

Last updated 2026-05-04

No results posted yet for this study

Summary

This is a Phase Ia/Ib, multicenter, open-label, first-in-human study to evaluate the safety, tolerability, PK, and efficacy of IBI343 in participants with locally advanced unresectable or metastatic solid tumors. It is planned to be carried out in different countries or regions such as China, Australia and US.

There are three parts in phase Ia. Part 1 includes dose escalation and expansion phase and part 2 is designed for dose optimization for IBI343 monotherapy.

Part 3 1L G/GEJ AC and 1L PDAC cohorts will include an initial safety lead-in stage to confirm the tolerability of IBI343 in combination with chemotherapy in 1L PDAC and G/GEJ AC, followed by a randomized dose-optimization stage designed to further characterize safety, pharmacokinetics, and preliminary efficacy to inform selection of the recommended Phase 3 dose.

Conditions

  • Locally Advanced Unresectable or Metastatic Solid Tumors

Interventions

DRUG

IBI343

IBI343 will be administered intravenously (IV) on Day 1 of every 21-day cycle.

DRUG

FOLFIRINOX/mFOLFIRINOX

FOLFIRINOX/mFOLFIRINOX will be administered IV Q2W on Days 1-3 every 2 weeks (14 days).

DRUG

mFOLFOX

mFOLFOX will be administered IV Q2W on Days 1-3 every 2 weeks (14 days) in each cycle after IBI343

DRUG

IBI343

IBI343 will be administered IV Q2W on Day1 (14 days).

Sponsors & Collaborators

  • Fortvita Biologics (USA)Inc.

    collaborator INDUSTRY

  • TigerMed

    collaborator INDUSTRY

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-26
Primary Completion
2027-06-30
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China

Study Locations

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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 NCT05458219 on ClinicalTrials.gov