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NCT04890613 · ClinicalTrials.gov registry record · Phase 1
Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation
A Phase 1 study of Advanced Solid Tumor, sponsored by Senhwa Biosciences.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 8
- Study locations
NCT04890613: Recruiting Phase 1 study of Advanced Solid Tumor, sponsored by Senhwa Biosciences.
NCT04890613 is a Phase 1 study of Advanced Solid Tumor that is actively recruiting participants, run by Senhwa Biosciences. The registered enrollment target is 52 participants, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (73% lower). The trial reports 8 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04890613, a Phase 1 study of Advanced Solid Tumor, is actively recruiting participants, sponsored by Senhwa Biosciences.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 8
- Study locations
Study Summary
This is an open-label, multi-center, phase 1b study designed to determine a tolerable dose of CX-5461 administered by IV infusion on Day 1 and Day 8 of a 28-day cycle in patients with selected solid tumours and associated mutations for future Phase II trials. The safety and tolerability of CX-5461, preliminary evidence of antitumor effect and the effect of CX-5461 on the Health-Related Quality of Life (HRQoL) will also be evaluated. The study will also evaluate the predictive value of mutational signatures and explore the significance of dynamic changes in ctDNA levels and plasma DNA methylome profiling in this study's exploratory cohort.
Primary Outcome
To identify the number of patients who discontinue study drug due to toxicity for each of the two dosing regimens independently.
Conditions Studied
Interventions
- DRUG CX-5461
Study Locations (8)
California
- University of California, Los Angeles - Santa Monica
Florida
- H. Lee Moffitt Cancer Center and Research Institute Hospital - Tampa
Massachusetts
- Dana Farber Cancer Institute - Boston
New York
- Memorial Sloan-Kettering Cancer Center - New York
Ohio
- Ohio State University-James Cancer Hospital and Solove Research Institute - Columbus
Pennsylvania
- UPMC Hillman Cancer Center - Pittsburgh
Ontario
- Princess Margaret Cancer Centre - Toronto
Quebec
- Centre hospitalier de l'Université de Montréal (CHUM) - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2021-09-08 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What NCT04890613 shows while recruiting
NCT04890613 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 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Advanced Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which CX-5461 is the first listed.
NCT04890613 lists 8 locations in 8 states (California, Florida, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT04890613 about?
NCT04890613 is a clinical study titled "Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation". This is an open-label, multi-center, phase 1b study designed to determine a tolerable dose of CX-5461 administered by IV infusion on Day 1 and Day 8 of a 28-day cycle in patients with selected solid tumours and associated mutations for future Phase II trials. The safety and tolerability of CX-5461, ...
What is the current status of trial NCT04890613?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2021-09-08. Estimated completion is 2026-12.
What conditions does trial NCT04890613 study?
This clinical trial studies the following conditions: Advanced Solid Tumor.
What interventions are being tested in trial NCT04890613?
The interventions under investigation include: CX-5461 (DRUG).
Who is sponsoring clinical trial NCT04890613?
This trial is sponsored by Senhwa Biosciences, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04890613 being conducted?
This trial has 8 study locations across California, Florida, Massachusetts, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04890613's enrollment target sits among peer trials
52 155th of 189 higher than 32 of 189 other Advanced Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumor 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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