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NCT05458219 · ClinicalTrials.gov registry record · Phase 1
A First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors
A Phase 1 study of Locally Advanced Unresectable or Metastatic Solid Tumors, sponsored by Innovent Biologics (Suzhou) Co..
- Recruiting
- Registry status
- Phase 1
- Development phase
- 470
- Enrollment target
- 20
- Study locations
NCT05458219: Recruiting Phase 1 study of Locally Advanced Unresectable or Metastatic Solid Tumors, sponsored by Innovent Biologics (Suzhou) Co..
NCT05458219 is a Phase 1 study of Locally Advanced Unresectable or Metastatic Solid Tumors that is actively recruiting participants, run by Innovent Biologics (Suzhou) Co.. The registered enrollment target is 470 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (683% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05458219, a Phase 1 study of Locally Advanced Unresectable or Metastatic Solid Tumors, is actively recruiting participants, sponsored by Innovent Biologics (Suzhou) Co..
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 470 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0.
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 |
What NCT05458219 shows while recruiting
NCT05458219 is an interventional study that assigns participants to a tested intervention. The registered 470 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (683% higher).
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.
NCT05458219 names 20 study sites across 10 states, led by Texas, Anhui, New South Wales.
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.
What interventions are being tested in trial NCT05458219?
The interventions under investigation include: IBI343 (DRUG), FOLFIRINOX/mFOLFIRINOX (DRUG), mFOLFOX (DRUG).
Who is sponsoring clinical trial NCT05458219?
This trial is sponsored by Innovent Biologics (Suzhou) Co., which has 7 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05458219's enrollment target sits among peer trials
470 52nd of 2000 higher than 1,949 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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