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Tyrosine Kinase Inhibitor

CGT9486 + Sunitinib for GIST

Phase 3
Recruiting
Research Sponsored by Cogent Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Part 1b: Treatment with ≥2 prior TKI for GISTs
Part 2: Prior treatment with imatinib only
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 48 months
Awards & highlights

Study Summary

This trial will evaluate the efficacy of CGT9486 in combination with sunitinib compared to sunitinib alone in patients with gastrointestinal stromal tumors (GIST) who are intolerant to, or who have failed, prior treatment with imatinib. Approximately 426 patients will be enrolled in this open-label, international, multicenter study.

Who is the study for?
This trial is for patients with advanced, metastatic, or unresectable Gastrointestinal Stromal Tumors (GIST) who have been previously treated. Part 1 requires treatment with at least one prior therapy; Part 2 requires previous imatinib treatment only. Participants must have measurable lesions and be in stable health as indicated by ECOG scores of 0 to 2.Check my eligibility
What is being tested?
The study tests CGT9486 combined with sunitinib versus sunitinib alone in a Phase 3 trial involving around 426 patients. It includes initial evaluations of dosage and drug interactions followed by efficacy comparison between the two treatments for those intolerant or unresponsive to imatinib.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical reactions associated with cancer therapies such as nausea, fatigue, cardiac issues due to CGT9486 or sunitinib, and possible drug interaction effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been treated with 2 or more TKIs for my GIST.
Select...
I have only been treated with imatinib before.
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My GIST is advanced, can't be surgically removed, and I have or need a molecular pathology report.
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My condition worsened or I couldn't tolerate imatinib.
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I can take care of myself and am up and about more than half of my waking hours.
Select...
I have received at least one treatment for GIST before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1a - pharmacokinetics - AUC
Part 1a - pharmacokinetics - Cmax
Part 1b - pharmacokinetics - AUC
+3 more
Secondary outcome measures
All Study Parts - Disease Control Rate (DCR)
All Study Parts - Duration of Response (DOR)
All Study Parts - Objective Response Rate (ORR)
+4 more

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Part 2 - Experimental GroupExperimental Treatment1 Intervention
CGT9486 plus sunitinib 37.5 mg QD
Group II: Part 1b - DDI Cohort 2Experimental Treatment1 Intervention
sunitinib 37.5 mg QD plus CGT9486
Group III: Part 1b - DDI Cohort 1Experimental Treatment1 Intervention
CGT9486 plus sunitinib 37.5 mg QD
Group IV: Part 1aExperimental Treatment1 Intervention
CGT9486 plus sunitinib 37.5 mg QD
Group V: Part 2 - Control GroupActive Control1 Intervention
sunitinib 37.5 mg QD
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sunitinib
2014
Completed Phase 3
~4380

Find a Location

Who is running the clinical trial?

Cogent Biosciences, Inc.Lead Sponsor
9 Previous Clinical Trials
472 Total Patients Enrolled
Jessica Sachs, MDStudy DirectorCogent Biosciences
6 Previous Clinical Trials
375 Total Patients Enrolled

Media Library

CGT9486 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05208047 — Phase 3
Gastrointestinal Stromal Tumor Research Study Groups: Part 1a, Part 1b - DDI Cohort 2, Part 2 - Experimental Group, Part 1b - DDI Cohort 1, Part 2 - Control Group
Gastrointestinal Stromal Tumor Clinical Trial 2023: CGT9486 Highlights & Side Effects. Trial Name: NCT05208047 — Phase 3
CGT9486 (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05208047 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the goals of this particular research project?

"Cogent Biosciences, Inc., the sponsor of this trial, has specified that the primary outcome measure for this study will be Part 1b - pharmacokinetics - T1/2. This outcome will be assessed over a 14-day period. Additionally, this trial will also evaluate secondary outcomes including All Study Parts - Evaluating the effect of each treatment regimen on pharmacodynamic biomarkers (i.e. Determination of baseline genetic expression measured from peripheral blood to assess relationship with efficacy and safety outcomes), All Study Parts - Disease Control Rate (DCR; i.e. Percentage of subjects who achieved CR +"

Answered by AI

Are volunteers still being accepted for this experiment?

"That is correct, the study detailed on clinicaltrials.gov is currently recruiting patients. The trial was posted on April 14th, 2022 and edited November 14th, of the same year. They are looking for 426 individuals total from 15 different locations."

Answered by AI

How many patients will be included in this research project?

"A total of 426 patients are needed to enroll in this trial, provided they meet the inclusion criteria. There are several locations where patients can take part in this study, such as Memorial Sloan Kettering Cancer Center and University of Colorado Denver."

Answered by AI

What are the potential adverse effects of CGT9486?

"CGT9486 is in Phase 3 of clinical trials, meaning that there is some efficacy data as well as multiple rounds of safety data. Therefore, it receives a score of 3."

Answered by AI

Are there any hospitals or research centers in Canada conducting this clinical trial?

"There are a total of 15 sites for this trial, with 3 located in New york, Denver and Philadelphia. The other 12 locations are also based in the USA. If you want to participate it is recommended that you choose a location near to minimize travel disruption."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
How old are they?
18 - 65
What site did they apply to?
University of Colorado Denver
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors
2022. "(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05208047.
All > Sutent
~157 spots leftby Jul 2025
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