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NCT04579757 · ClinicalTrials.gov registry record · Phase 1
Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors
A Phase 1 study, sponsored by Hutchmed.
- Terminated
- Registry status
- Phase 1
- Development phase
- 87
- Enrollment target
NCT04579757: Clinical Trial Phase 1 study, sponsored by Hutchmed.
NCT04579757 is a Phase 1 study that was terminated before completion, run by Hutchmed. The registered enrollment target is 87 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04579757, a Phase 1 study, was terminated before completion, sponsored by Hutchmed.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 87 participants
- Enrollment target
Study Summary
This open-label, phase Ib/II study of surufatinib in combination with tislelizumab will evaluate the safety, tolerability, PK and efficacy in patients with advanced solid tumors. The study consists of 2 parts - dose finding (Part 1) and dose expansion (Part 2).
Primary Outcome
According to National Cancer Institute Common Terminology Criteria for Adverse Events(AEs) version (v)5.0,DLT was defined as any of the following AEs during DLT observation period: Nonhematologic toxicities:grade 3 or higher nonhematologic toxicity, except for grade 3 fatigue lasting \<7 days, grade 3 rash returning to baseline or ≤grade 1 within 7 days with treatment, grade 3 hypertension downgraded to ≤grade 1 within 7 days with therapy, grade 3 endocrinopathy controlled by hormonal replaceme
Interventions
- DRUG Surufatinib and Tislelizumab _ Part 1
- DRUG Surufatinib and Tislelizumab _ Part 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2021-03-05 |
| Est. Completion | 2024-08-27 |
| Phase | Phase 1 |
Why NCT04579757 stopped before completion
NCT04579757 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% higher).
The record links to 0 conditions, and to 2 interventions - of which Surufatinib and Tislelizumab _ Part 1 is the first listed.
NCT04579757 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04579757 about?
NCT04579757 is a clinical study titled "Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors". This open-label, phase Ib/II study of surufatinib in combination with tislelizumab will evaluate the safety, tolerability, PK and efficacy in patients with advanced solid tumors. The study consists of 2 parts - dose finding (Part 1) and dose expansion (Part 2).
What is the current status of trial NCT04579757?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 87 participants. The study started on 2021-03-05. Estimated completion is 2024-08-27.
What interventions are being tested in trial NCT04579757?
The interventions under investigation include: Surufatinib and Tislelizumab _ Part 1 (DRUG), Surufatinib and Tislelizumab _ Part 2 (DRUG).
Who is sponsoring clinical trial NCT04579757?
This trial is sponsored by Hutchmed, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04579757's enrollment target sits among peer trials
87 651st of 2000 higher than 1,349 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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