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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
Must not have
Known PDGFR driving mutations or known succinate dehydrogenase deficiency
Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 48 months
Awards & highlights
Pivotal Trial
No Placebo-Only Group

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.
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.
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.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer has a PDGFR mutation or lacks succinate dehydrogenase.
Select...
I have not had major surgery in the last 4 weeks.
Select...
I have taken strong medications that affect liver enzymes.
Select...
I do not have any active bleeding except for hemorrhoids or gums.
Select...
I have a serious heart condition.
Select...
I do not have severe stomach or bowel issues affecting food absorption.
Select...
I do not have any ongoing serious infections.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
DDI Substudy - pharmacokinetics - AUC
DDI Substudy - pharmacokinetics - Cmax
Part 1a - pharmacokinetics - AUC
+5 more
Secondary study objectives
All Study Parts - observing the safety of each treatment regimen.
Part 1a, Part 1b, Part 2 - Disease Control Rate (DCR)
Part 1a, Part 1b, Part 2 - Duration of Response (DOR)
+4 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment 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: DDI Substudy (Midazolam)Experimental Treatment2 Interventions
Midazolam, CGT9486, sunitinib
Group VI: Part 2 - Control GroupActive Control1 Intervention
sunitinib 37.5 mg QD
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midazolam
2018
Completed Phase 4
~1910
Sunitinib
2014
Completed Phase 3
~4380

Find a Location

Who is running the clinical trial?

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

Media Library

CGT9486 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05208047 — Phase 3
Gastrointestinal Stromal Tumor Research Study Groups: DDI Substudy (Midazolam), 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
~70 spots leftby Jul 2025
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