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NCT04577963 · ClinicalTrials.gov registry record · Phase 1
A Study of Fruquintinib in Combination With Tislelizumab in Advanced Solid Tumors
A Phase 1 study, sponsored by Hutchmed.
- Terminated
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT04577963: Clinical Trial Phase 1 study, sponsored by Hutchmed.
NCT04577963 is a Phase 1 study that was terminated before completion, run by Hutchmed. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04577963, a Phase 1 study, was terminated before completion, sponsored by Hutchmed.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
This is an open-label, multi-center, non-randomized, Phase 1b/2 study to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with locally advanced or metastatic solid tumors. This study will be conducted in 2 parts; a Safety Lead-in Phase (Part 1) and a Dose Expansion Phase (Part 2). The Safety Lead-in Phase, open to any-comer solid tumors, will determine the RP2D. The RP2D will be administered to 3 cohorts of patients in the Dose Expansion Phase. * Cohort A: Advanced or Metastatic Triple Negative Breast Cancer (TNBC) (IO-treated) * Cohort B: Advanced or Metastatic Triple Negative Breast Cancer (TNBC) (IO-Naïve) * Cohort C: Advanced or Metastatic Endometrial Cancer (EC) (IO-Naïve) * Cohort D: Advanced or Metastatic Colorectal Cancer (mCRC) (IO-Naïve)
Primary Outcome
According to National Cancer Institute Common Terminology Criteria for Adverse Events(AEs) v5.0, DLT was defined as any 1 of following toxicities during DLT assessment window and considered by Investigator to be related to 1 or more study treatments:a)Hematologic: grade(G) 4 neutropenia lasting \>7 days, G ≥3 febrile neutropenia, G 3 thrombocytopenia with clinically significant bleeding, G 4 thrombocytopenia, G ≥4 anemia.b) Non-hematologic:all G ≥3 non-hematologic toxicities except:G 3 endocrino
Interventions
- DRUG Tislelizumab
- DRUG Fruquintinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2021-08-09 |
| Est. Completion | 2024-06-18 |
| Phase | Phase 1 |
Why NCT04577963 stopped before completion
NCT04577963 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 2 interventions - of which Tislelizumab is the first listed.
NCT04577963 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04577963 about?
NCT04577963 is a clinical study titled "A Study of Fruquintinib in Combination With Tislelizumab in Advanced Solid Tumors". This is an open-label, multi-center, non-randomized, Phase 1b/2 study to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with locally advanced or metastatic solid tumors. This study will be conducted in 2 parts; a Safety Lead-in Phase (Part 1) and a Dose E...
What is the current status of trial NCT04577963?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2021-08-09. Estimated completion is 2024-06-18.
What interventions are being tested in trial NCT04577963?
The interventions under investigation include: Tislelizumab (DRUG), Fruquintinib (DRUG).
Who is sponsoring clinical trial NCT04577963?
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 NCT04577963's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 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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