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RECRUITING Phase 1

Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness

NCT05691491 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 58 participants
Start Date 2023-09-28
Est. Completion 2027-03-01
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05691491

The ClinicalTrials.gov registry entry for NCT05691491 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05691491 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Missouri, Kansas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05691491?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial