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NCT03568539 · ClinicalTrials.gov registry record · Phase 1
IBI308 in Subjects With Advanced/Metastatic Solid Malignancies
A Phase 1 study, sponsored by Innovent Biologics (Suzhou) Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT03568539: Completed Phase 1 study, sponsored by Innovent Biologics (Suzhou) Co..
NCT03568539 is a Phase 1 study that has completed, run by Innovent Biologics (Suzhou) Co.. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03568539, a Phase 1 study, has completed, sponsored by Innovent Biologics (Suzhou) Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
The study is to evaluate preliminary anti-tumor activity (overall response rate, ORR) of IBI308 monotherapy in subjects with advanced/metastatic solid malignancies. Patients will be recruited for 2 cohorts: • Cohort 1: Advanced/metastatic cancers with TMB\>10 mutations per megabase (mut/Mb). This enrollment of this cohort has been stopped per sponsor's communication with the sites. For patients who have already enrolled in this cohort, treatment and monitoring will be conducted as stipulated by the protocol. The patients will remain on study until disease progression or intolerable toxicity, death, withdrawal of consent, or end of study, whichever occurs first. Cohort 2: Advanced/metastatic endometrial cancer (N=40)
Primary Outcome
To evaluate preliminary anti-tumor activity (overall response rate, ORR) of IBI308 monotherapy in subjects with advanced/metastatic solid malignancies. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Interventions
- DRUG IBI308
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2018-06-27 |
| Est. Completion | 2020-12-07 |
| Phase | Phase 1 |
What the finished NCT03568539 record still lists
NCT03568539 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 1 intervention - of which IBI308 is the first listed.
NCT03568539 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03568539 about?
NCT03568539 is a clinical study titled "IBI308 in Subjects With Advanced/Metastatic Solid Malignancies". The study is to evaluate preliminary anti-tumor activity (overall response rate, ORR) of IBI308 monotherapy in subjects with advanced/metastatic solid malignancies. Patients will be recruited for 2 cohorts: • Cohort 1: Advanced/metastatic cancers with TMB\>10 mutations per megabase (mut/Mb). This ...
What is the current status of trial NCT03568539?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2018-06-27. Estimated completion is 2020-12-07.
What interventions are being tested in trial NCT03568539?
The interventions under investigation include: IBI308 (DRUG).
Who is sponsoring clinical trial NCT03568539?
This trial is sponsored by Innovent Biologics (Suzhou) Co., which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03568539's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 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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