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A First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors
NCT05458219 · View on ClinicalTrials.gov ↗
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. Part 3 metabolite profiling cohort is designed to explore the payload metabolites in an advanced PDAC population.
Conditions Studied
Interventions
- DRUG IBI343
- DRUG FOLFIRINOX/mFOLFIRINOX
- DRUG mFOLFOX
Study Locations (20)
Texas
- NEXT Austin — Austin
- NEXT Dallas — Irving
- NEXT San Antonio — San Antonio
Anhui
- Anhui Cancer Hospital — Hefei
- Anhui Provincial Hospital — Hefei
- The First Affiliated Hospital of Wannan Medical College — Wuhu
New South Wales
- St Vincent Hospital — Darlinghurst
- Cancer Care Wollongong — Wollongong
Queensland
- Pindara Private Hospital — Benowa
- Sunshine Coast University Private Hospital — Birtinya
Beijing Municipality
- Beijing Cancer Hospital — Beijing
- Tumor Hospital, Chinese Academy of Medical Sciences — Beijing
Guangzhou
- Sun Yat-sen Memorial Hospital Sun Yat-Sen university — Guangzhou
- The First Affiliated Hospital of Sun Yat-sen University — Guangzhou
Henan
- Henan Provincial People's Hospital — Zhengzhou
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou
Hubei
- Hubei Cancer Hospital — Wuhan
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technolog — Wuhan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 470 participants |
| Start Date | 2022-10-26 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05458219
The ClinicalTrials.gov registry entry for NCT05458219 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 470 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Innovent Biologics (Suzhou) Co., which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Locally Advanced Unresectable or Metastatic Solid Tumors appearing as the primary indexed condition, and to 3 interventions — of which IBI343 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05458219 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Texas, Anhui, New South Wales. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05458219 about?
NCT05458219 is a clinical study titled "A First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors". 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, Austra...
What is the current status of trial NCT05458219?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 470 participants. The study started on 2022-10-26. Estimated completion is 2027-12-31.
What conditions does trial NCT05458219 study?
This clinical trial studies the following conditions: Locally Advanced Unresectable or Metastatic Solid Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05458219?
The interventions under investigation include: IBI343 (DRUG), FOLFIRINOX/mFOLFIRINOX (DRUG), mFOLFOX (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05458219?
This trial is sponsored by Innovent Biologics (Suzhou) Co., which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05458219 being conducted?
This trial has 20 study locations across Texas, New South Wales, Queensland, Anhui, Beijing Municipality. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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