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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 is a Phase 1 study that has completed, run by Innovent Biologics (Suzhou) Co.. The registered enrollment target is 39 participants.
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)
Interventions
- DRUG IBI308
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2018-06-27 |
| Est. Completion | 2020-12-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03568539
The ClinicalTrials.gov registry entry for NCT03568539 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 39 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 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which IBI308 is the first listed.
NCT03568539 reports 0 study locations.
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.
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