Gastrointestinal Neoplasms, Gastrointestinal Stromal TumorsNCT06948955
Expanded Access to Bezuclastinib to be Coadministered With Sunitinib for Patients With Gastrointestinal Stromal Tumors
A study testing Bezuclastinib and Sunitinib in people with Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors, run by Cogent Biosciences, Inc. at 26 sites in United States.
Trial summary
The purpose of this expanded access program (EAP) is to provide investigational bezuclastinib so that it can be coadministered with sunitinib to patients with a diagnosis of gastrointestinal stromal tumors (GIST) with no comparable or satisfactory alternative therapy options. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors
- What is being tested?
- Bezuclastinib and Sunitinib
- How many people
- Not given
- Where
- 26 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent and commit to recommended EAP assessments.
- ≥18 years of age.
- Able to swallow tablets.
- Histologically confirmed locally advanced, metastatic, and/or unresectable GIST.
- Intolerant to imatinib or received prior imatinib therapy for treatment of advanced, metastatic, and/or unresectable GIST that resulted in disease progression.
- Meet clinically acceptable local laboratory results.
Who cannot join
- Patients who are eligible for and capable of participating in and/or enrolled in an on-going bezuclastinib clinical trial.
- Prior or known intolerance to sunitinib.
- Patients who have previously participated in a bezuclastinib clinical trial.
- Patients with persistent > Grade 2 toxicities from prior therapy.
- Known PDGFR driving mutations or known SDH deficiency.
- Pregnant or currently breastfeeding.
- Other protocol-defined criteria apply.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
- Available
University of Colorado
Aurora, Colorado, 80045
Steven Sares, steven.sares@cuanschutz.edu
Natalie Frisbie, natalie.frisbie@cuanschutz.edu
- Available
Johns Hopkins University
Baltimore, Maryland, 21287
Christian Meyer, MD
cmeyer13@jh.edu
- Available
Dana Farber Cancer Institute (DFCI)
Boston, Massachusetts, 02215
Sarcoma Center, 617-632-5204
- Available
Roswell Park Cancer Institute
Buffalo, New York, 14263
Christopher Kirsch, 716-845-1300 ext. 2674, Christopher.Kirsch@RoswellPark.org
- Available
Northwestern Memorial Hospital
Chicago, Illinois, 60611
312-695-9367, cancer@northwestern.edu
- Available
The University of Chicago Medical Center
Chicago, Illinois, 60637
cancerclinicaltrials@bsd.uchicago.edu
- Available
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Cancer Answer Line, 216-444-7923
(866) 223-810
- Available
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Luiza Stoeva, SarcomaCRCs@osumc.edu
- Available
Karmanos Cancer Institute
Detroit, Michigan, 48201
Sharon Prokop, 313-576-9363, prokops@karmanos.org
- Available
MD Anderson Cancer Center
Houston, Texas, 77030
Dheeraj Narla, dnarla@mdanderson.org
- Available
Mayo Clinic
Jacksonville, Florida, 32224
Jenna Heller, 904-953-2000, Heller.Jenna2@mayo.edu
- Available
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Rabia Rehman, 323-865-0460, rabia.rehman@med.usc.edu
- Available
UCLA Department of Medicine- Hematology/Oncology
Los Angeles, California, 90095
Soheila Abbassi, sabbassi@mednet.ucla.edu
- Available
Taylor Cancer Research Center
Maumee, Ohio, 43537
Stephanie Ambrose, RN, 567-402-4500, SAmbrose@tcrcpt.org
- Available
Smillow Cancer Hospital - Yale New Haven Health
New Haven, Connecticut, 06510
Sharon Huie, sharon.huie@yale.edu
- Available
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
William Tap, MD, 347-971-3395, tapw@mskcc.org
- Available
Orlando Health
Orlando, Florida, 32806
Tirrell Tremayne Johnson, 321-841-6059, tirrell.johnson@orlandohealth.com
- Available
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Atrayee Basu Mallick, MD, Atrayee.BasuMallick@jefferson.edu
Elizabeth Gudesblat, 215-955-1661, Elizabeth.Gudesblat@jefferson.edu
- Available
Mayo Clinic Hospital
Phoenix, Arizona, 85054
Mahesh Seetharam, MD, 855-776-0015
- Available
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Danielle Bednarz, 412-623-1191, bednarzdl@upmc.edu
- Available
Oregon Health and Sciences University
Portland, Oregon, 97239
Clinical Trials Office, 503-494-1080, trials@ohsu.edu
- Available
Mayo Clinic
Rochester, Minnesota, 55905
Thanh Ho, MD, 855-776-0015, Ho.Thanh@mayo.edu
- Available
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
Susan Sharry, 801-585-3453, susan.sharry@hci.utah.edu
- Available
Northwest Medical Specialties
Tacoma, Washington, 98405
Jeni Spokely, 253-999-3701, Research@southsoundcare.org
- Available
Shenandoah Oncology
Winchester, Virginia, 22601
Stacey Carpenter, 540-662-1108, stacey.carpenter@usoncology.com
- Available
Shenandoah Oncology
Winchester, Virginia, 22601
Stacey Carpenter
540-662-1108, Stacey.carpenter@usoncology.com
About this study
Official title: Expanded Access to Bezuclastinib to be Coadministered With Sunitinib for Patients With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors
The purpose of this expanded access program (EAP) is to provide investigational bezuclastinib so that it can be coadministered with sunitinib to patients with a diagnosis of gastrointestinal stromal tumors (GIST) with no comparable or satisfactory alternative therapy options. The combination of bezuclastinib and sunitinib provides broad inhibition of all primary and secondary KIT mutations that commonly occur in GIST.
- Being tested
- Bezuclastinib, Sunitinib
- Keywords
- Solid Tumors, Sunitinib, Bezuclastinib, Gastrointestinal Stromal Tumors
- Medical subject headings
- Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BezuclastinibDrug
Drug: Bezuclastinib
SunitinibDrug
Drug: Sunitinib (locally sourced)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Neoplasms, Gastrointestinal Stromal TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Cogent Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rachael Easton, MD, PhD, Study director, Cogent Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948955
- Sponsor's protocol ID
- CGT9486-EAP-002
- Status last verified
- Jul 2026
- First submitted
- 31 Mar 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access to Bezuclastinib to be Coadministered With Sunitinib for Patients With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors
- ClinicalTrials.gov ID
- NCT06948955
- Acronym / sponsor ID
- CGT9486-EAP-002
- Keywords
- Solid Tumors, Sunitinib, Bezuclastinib, Gastrointestinal Stromal Tumors
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Cogent Biosciences, Inc.Industry (pharma, biotech, devices)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this expanded access program (EAP) is to provide investigational bezuclastinib so that it can be coadministered with sunitinib to patients with a diagnosis of gastrointestinal stromal tumors (GIST) with no comparable or satisfactory alternative therapy options. The combination of bezuclastinib and sunitinib provides broad inhibition of all primary and secondary KIT mutations that commonly occur in GIST.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to provide written informed consent and commit to recommended EAP assessments.
- ≥18 years of age.
- Able to swallow tablets.
- Histologically confirmed locally advanced, metastatic, and/or unresectable GIST.
- Intolerant to imatinib or received prior imatinib therapy for treatment of advanced, metastatic, and/or unresectable GIST that resulted in disease progression.
Key exclusion criteria (7 listed)
- Patients who are eligible for and capable of participating in and/or enrolled in an on-going bezuclastinib clinical trial.
- Prior or known intolerance to sunitinib.
- Patients who have previously participated in a bezuclastinib clinical trial.
- Patients with persistent > Grade 2 toxicities from prior therapy.
- Known PDGFR driving mutations or known SDH deficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BezuclastinibDrug: Bezuclastinib | Drug | – |
| SunitinibDrug: Sunitinib (locally sourced) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachael Easton, MD, PhD study director
Cogent Biosciences, Inc.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bezuclastinib and Sunitinib in people with Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors, run by Cogent Biosciences, Inc. at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Malinowski, PharmD (1-877-633-8049, EAP@cogentbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.