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Study identifier: NCT05458219 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Recruiting

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

Condition: Locally Advanced Unresectable or Metastatic Solid Tumors  ·  Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

PhasePhase 1
Planned participants470
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Suhua Dong  ·  0512-69566088  ·  suhua.dong@innoventbio.com

Always discuss trial participation with your own doctor first.

Locations (39)

Next Oncology-AustinAustin, Texas, United StatesRecruiting
Next Oncology-DallasIrving, Texas, United StatesRecruiting
Next Oncology-San AntonioSan Antonio, Texas, United StatesRecruiting
St Vincent's Hospital SydneyDarlinghurst, New South Wales, AustraliaRecruiting
Cancer Care WollongongWollongong, New South Wales, AustraliaRecruiting
Pindara Private HospitalBenowa, Queensland, AustraliaActive Not Recruiting
Sunshine Coast University Private HospitalBirtinya, Queensland, AustraliaRecruiting
Anhui Cancer HospitalHefei, Anhui, ChinaRecruiting
Anhui Provincial HospitalHefei, Anhui, ChinaRecruiting
The First Affiliated Hospital of Wannan Medical CollegeWuhu, Anhui, ChinaRecruiting
Beijing Cancer HospitalBeijing, Beijing Municipality, ChinaRecruiting
Tumor Hospital, Chinese Academy of Medical SciencesBeijing, Beijing Municipality, ChinaRecruiting

+ 27 more locations — full list on the registry record.

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