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NCT06606990 · ClinicalTrials.gov registry record · Phase 1
Testing How the Body Responds to the Drug CX-5461 (Pidnarulex) in Patients With Metastatic Solid Cancers
A Phase 1 study of Metastatic Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06606990: Recruiting Phase 1 study of Metastatic Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
NCT06606990 is a Phase 1 study of Metastatic Malignant Solid Neoplasm that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 40 participants, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06606990, a Phase 1 study of Metastatic Malignant Solid Neoplasm, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial tests the safety, side effects, and best dose of pidnarulex (CX-5461) in treating patients with solid tumors that have spread from where it first started (primary site) to other places in the body (metastatic). Pidnarulex is an oral inhibitor of ribonucleic acid polymerase I, with potential antineoplastic activity. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill cancer cells.
Primary Outcome
Will be defined as at least 5 percent of cells with at least 5 positive foci per nucleus. Will target a 30% Rad51 response rate. Will be compared descriptively across the 2 cohorts, with and without homologous repair deficiency mutations.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Biopsy Procedure
- PROCEDURE Echocardiography Test
Study Locations (1)
Maryland
- National Cancer Institute Developmental Therapeutics Clinic - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-07-01 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What NCT06606990 shows while recruiting
NCT06606990 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06606990 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06606990 about?
NCT06606990 is a clinical study titled "Testing How the Body Responds to the Drug CX-5461 (Pidnarulex) in Patients With Metastatic Solid Cancers". This phase I trial tests the safety, side effects, and best dose of pidnarulex (CX-5461) in treating patients with solid tumors that have spread from where it first started (primary site) to other places in the body (metastatic). Pidnarulex is an oral inhibitor of ribonucleic acid polymerase I, with...
What is the current status of trial NCT06606990?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2025-07-01. Estimated completion is 2026-12-31.
What conditions does trial NCT06606990 study?
This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm.
What interventions are being tested in trial NCT06606990?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Biopsy Procedure (PROCEDURE), Echocardiography Test (PROCEDURE).
Who is sponsoring clinical trial NCT06606990?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06606990 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06606990's enrollment target sits among peer trials
40 63rd of 92 higher than 25 of 92 other Metastatic Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Malignant Solid Neoplasm 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.
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