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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04890613
The ClinicalTrials.gov registry entry for NCT04890613 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (73% lower). The listed sponsor is Senhwa Biosciences, which has 4 total studies on file at ClinicalTrials.gov.
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 reports 8 study locations spanning 8 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.