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NCT06655246 · ClinicalTrials.gov registry record · Phase 1

A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)

A Phase 1 study of Gastrointestinal Stromal Tumor (GIST) and Gastrointestinal Stromal Neoplasm, sponsored by Kura Oncology.

Recruiting
Registry status
Phase 1
Development phase
157
Enrollment target
20
Study locations

NCT06655246: Recruiting Phase 1 study of Gastrointestinal Stromal Tumor (GIST) and Gastrointestinal Stromal Neoplasm, sponsored by Kura Oncology.

NCT06655246 is a Phase 1 study of Gastrointestinal Stromal Tumor (GIST) and Gastrointestinal Stromal Neoplasm that is actively recruiting participants, run by Kura Oncology. The registered enrollment target is 157 participants, roughly in line with the 168-participant average among 6 other Gastrointestinal Stromal Tumor (GIST) trials with a reported enrollment target. The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06655246, a Phase 1 study of Gastrointestinal Stromal Tumor (GIST) and Gastrointestinal Stromal Neoplasm, is actively recruiting participants, sponsored by Kura Oncology.

RECRUITING
Registry status
Phase 1
Development phase
157 participants
Enrollment target
20
Study locations

Study Summary

In this clinical trial, the safety, tolerability, and preliminary antitumor activity of ziftomenib in combination with imatinib will be evaluated in adults with gastrointestinal stromal tumors (GIST) who have been treated previously with imatinib.

Primary Outcome

Rate of DLTs per dose level

Conditions Studied

Gastrointestinal Stromal Tumor (GIST) Gastrointestinal Stromal Neoplasm Gastrointestinal Stromal Cancer Gastrointestinal Stromal Tumor, Malignant Gastrointestinal Stromal Cell Tumors

Interventions

  • DRUG ziftomenib
  • DRUG imatinib mesylate

Study Locations (20)

California

  • University of California, San Diego - La Jolla
  • University of Southern California - Los Angeles
  • University Of California, Irvine - Orange
  • Stanford Cancer Institute - Palo Alto
  • UCLA Santa Monica Medical Center - Santa Monica

Colorado

  • University of Colorado Cancer Center - Aurora
  • Sarah Cannon Research Institute - Denver

Florida

  • Mayo Clinic Cancer Center - Jacksonville
  • University of Miami - Miami

Massachusetts

  • Massachusetts General Hospital - Boston
  • Harvard University - Boston

Alabama

  • University of Alabama at Birmingham - Birmingham

Arizona

  • Mayo Clinic Cancer Center - Phoenix

Connecticut

  • Yale University School of Medicine - New Haven

Illinois

  • Northwestern University - Chicago

Trial Details

FieldValue
Enrollment Target 157 participants
Start Date 2025-03-27
Est. Completion 2028-12
Phase Phase 1
Kura Oncology

14 total trials

What NCT06655246 shows while recruiting

NCT06655246 is an interventional study that assigns participants to a tested intervention. The registered 157 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 168-participant average among 6 other Gastrointestinal Stromal Tumor (GIST) trials with a reported enrollment target.

The record links to 5 conditions, with Gastrointestinal Stromal Tumor (GIST) appearing as the primary indexed condition, and to 2 interventions - of which ziftomenib is the first listed.

NCT06655246 names 20 study sites across 13 states, led by California, Colorado, Florida.

Frequently Asked Questions

What is clinical trial NCT06655246 about?

NCT06655246 is a clinical study titled "A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)". In this clinical trial, the safety, tolerability, and preliminary antitumor activity of ziftomenib in combination with imatinib will be evaluated in adults with gastrointestinal stromal tumors (GIST) who have been treated previously with imatinib.

What is the current status of trial NCT06655246?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 157 participants. The study started on 2025-03-27. Estimated completion is 2028-12.

What conditions does trial NCT06655246 study?

This clinical trial studies the following conditions: Gastrointestinal Stromal Tumor (GIST), Gastrointestinal Stromal Neoplasm, Gastrointestinal Stromal Cancer, Gastrointestinal Stromal Tumor, Malignant, Gastrointestinal Stromal Cell Tumors.

What interventions are being tested in trial NCT06655246?

The interventions under investigation include: ziftomenib (DRUG), imatinib mesylate (DRUG).

Who is sponsoring clinical trial NCT06655246?

This trial is sponsored by Kura Oncology, which has 14 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06655246 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT06655246

Source: ClinicalTrials.gov NCT06655246, the US trial registry maintained by the National Library of Medicine. NCT06655246 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.