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NCT05691491 · ClinicalTrials.gov registry record · Phase 1
Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness
A Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
- 20
- Study locations
NCT05691491: Recruiting Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
NCT05691491 is a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 58 participants, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (67% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05691491, a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase I/II trial studies the side effects and best dose of temozolomide and M1774 and how well they works in treating patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and may have spread to nearby tissue, lymph nodes, or distant parts of the body (advanced). Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill tumor cells and slow down or stop tumor growth. M1774 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Adding M1774 to temozolomide may shrink or stabilize cancer for longer than temozolomide alone.
Primary Outcome
Defined as adverse events meeting the criteria that are at least "possibly related" to TMZ or M1774. Dose limiting toxicity for temozolomide in combination with M1774 and the maximum tolerated dose or maximum safe dose. Will consider ten dose levels (dose level -2, -1, 1, 2, 3, 4, 5, 6, 7, 8). The Bayesian Optimal Interval (BOIN) design based on the cumulative number of patients who experience a dose-limiting toxicity (DLT) at the current dose level will be used to guide dose escalation.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Biopsy Procedure
- DRUG Temozolomide
Study Locations (20)
Missouri
- Siteman Cancer Center at Saint Peters Hospital - City of Saint Peters
- Siteman Cancer Center at West County Hospital - Creve Coeur
- University of Kansas Cancer Center - North - Kansas City
- University of Kansas Cancer Center - Lee's Summit - Lee's Summit
- University of Kansas Cancer Center at North Kansas City Hospital - North Kansas City
- Washington University School of Medicine - St Louis
- Siteman Cancer Center-South County - St Louis
- Siteman Cancer Center at Christian Hospital - St Louis
Kansas
- University of Kansas Clinical Research Center - Fairway
- University of Kansas Cancer Center - Kansas City
- University of Kansas Cancer Center-Overland Park - Overland Park
- University of Kansas Hospital-Indian Creek Campus - Overland Park
- University of Kansas Hospital-Westwood Cancer Center - Westwood
California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- UC San Diego Moores Cancer Center - La Jolla
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
Connecticut
- Yale University - New Haven
- Smilow Cancer Hospital Care Center-Trumbull - Trumbull
Illinois
- Memorial Hospital East - Shiloh
Maryland
- National Cancer Institute Developmental Therapeutics Clinic - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2023-09-28 |
| Est. Completion | 2027-03-01 |
| Phase | Phase 1 |
What NCT05691491 shows while recruiting
NCT05691491 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (67% lower).
The record links to 7 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05691491 names 20 study sites across 6 states, led by Missouri, Kansas, California.
Frequently Asked Questions
What is clinical trial NCT05691491 about?
NCT05691491 is a clinical study titled "Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness". This phase I/II trial studies the side effects and best dose of temozolomide and M1774 and how well they works in treating patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and may have spread to nearby tissue, lymph nodes, or di...
What is the current status of trial NCT05691491?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2023-09-28. Estimated completion is 2027-03-01.
What conditions does trial NCT05691491 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm, Stage IV Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8.
What interventions are being tested in trial NCT05691491?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Biopsy Procedure (PROCEDURE), Temozolomide (DRUG).
Who is sponsoring clinical trial NCT05691491?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05691491 being conducted?
This trial has 20 study locations across California, Connecticut, Illinois, Kansas, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05691491's enrollment target sits among peer trials
58 40th of 108 higher than 69 of 108 other Advanced Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced 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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