Advanced Gastrointestinal Stromal TumorsPhase 3NCT05208047

(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors

A Phase 3 study testing CGT9486, Sunitinib and Midazolam in people with Advanced Gastrointestinal Stromal Tumors and Metastatic Cancer, run by Cogent Biosciences, Inc. at 126 sites in 22 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Gastrointestinal Stromal Tumors, Metastatic Cancer
What is being tested?: CGT9486, Sunitinib and Midazolam
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 482 participants
Where: 126 sitesin 22 countries
Study dates: 14 Apr 2022to Jan 2030
Phase: Phase 3
Are there results?: Not yet: the study is under way

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
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically confirmed locally advanced, metastatic, and/or unresectable GIST. Molecular pathology report must be available for Part 2; if molecular pathology report is unavailable or inadequate, an archival or fresh tumor tissue sample will be required to evaluate mutational status prior to randomization. (GIST 1L Substudy: must have documented mutation in KIT Exon 9 with an available molecular pathology report; archival or fresh tumor tissue sample will be required)
Documented disease progression on or intolerance to imatinib (Part 1a, Part 1b, Part 2, DDI Substudy)
Subjects must have received the following treatment:
DDI Substudy/Part 1a: Treatment with ≥1 prior lines of therapy for GIST
Part 1b: Treatment with ≥2 prior TKI for GISTs
Part 2: Prior treatment with imatinib only

Show all 12Show fewer

GIST 1L Substudy: No prior systemic therapy for GIST including adjuvant therapy. Exception: up to 10 subjects with ongoing imatinib therapy of ≤4 weeks
Have at least 1 measurable lesion according to mRECIST v1.1 (Part1a, Part 1b, Part 2, GIST 1L Substudy)
Eastern Cooperative Oncology Group (ECOG) Status
0 to 2 (Part 1a, Part 1b, Part 2, DDI Substudy)
0 to 1 (GIST 1L Substudy)
Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits

Who cannot join

Known Platelet-Derived Growth Factor Receptor (PDGFR) driving mutations or known succinate dehydrogenase deficiency (Part 1a, Part 1b, Part 2, DDI Substudy)
Clinically significant cardiac disease
Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug (Part 1a, Part 1b, Part 2, DDI Substudy)
Gastrointestinal abnormalities including, but not limited to, significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption
Any active bleeding excluding hemorrhoidal or gum bleeding
Seropositive for HIV 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody.

Show all 9Show fewer

Active, uncontrolled, systemic bacterial, fungal, or viral infections at Screening
Received strong CYP3A4 inhibitors or inducers (Part 1a, Part 1b, Part 2, DDI Substudy)
Received sunitinib within 3 weeks (Part 1a, Part 1b, DDI Substudy)

Trial locations and contacts

126 sites in 22 countries. Contact the study team or a site near you to ask about taking part.

Cogent Biosciences contact

617-945-5576

peakinfo@cogentbio.com

Country

City, postcode or hospital

Sites recruiting now only

126 sites in 22 countries

United States36 sites, 8 recruiting

University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Active, not recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35249
Withdrawn
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Active, not recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
Active, not recruiting
Northwestern University
Chicago, Illinois, 60611
Recruiting
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Active, not recruiting
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Active, not recruiting
University of Colorado Denver
Denver, Colorado, 80204
Active, not recruiting
City of Hope
Duarte, California, 91010
Active, not recruiting
Duke University
Durham, North Carolina, 27705
Active, not recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009
Active, not recruiting
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242
Active, not recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Active, not recruiting
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Active, not recruiting
University of Tennessee
Knoxville, Tennessee, 37920
Withdrawn
University of California, Los Angeles (UCLA)
Los Angeles, California, 90404
Active, not recruiting
University of Wisconsin - Carbone Cancer Center
Madison, Wisconsin, 53705
Active, not recruiting
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Active, not recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Recruiting
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Recruiting
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763
Withdrawn
Orlando Health Cancer Institute
Orlando, Florida, 32806
Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Active, not recruiting
University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Active, not recruiting
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
Active, not recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Active, not recruiting
University of California, San Diego (UCSD)
San Diego, California, 92093
Active, not recruiting
University of California, San Francisco
San Francisco, California, 94158
Active, not recruiting
Mayo Clinic
Scottsdale, Arizona, 85259
Active, not recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Active, not recruiting
Washington University
St Louis, Missouri, 63130
Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Recruiting
University of Toledo Medical Center
Toledo, Ohio, 43614
Withdrawn
University of Arizona- Cancer Center
Tucson, Arizona, 85719
Active, not recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Recruiting

Other trials in United States

Italy12 sites

Centro Riferimento Oncologico - Aviano
Aviano, 33081
Active, not recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
Bologna, 40138
Active, not recruiting
ASST degli Spedali Civili di Brescia
Brescia, 25123
Active, not recruiting
IRCCS La Fondazione e l'Istituto di Candiolo
Candiolo, 10060
Withdrawn
Azienda Ospedaliero-Universitaria Careggi
Florence, 50134
Active, not recruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"
Meldola, 47014
Active, not recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Active, not recruiting
Istituto Europeo di Oncologia
Milan, 20141
Active, not recruiting
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, 90127
Active, not recruiting
Policlinico Universitario Campus Bio-Medico
Roma, 00128
Active, not recruiting
Istituto Clinico Humanitas
Rozzano, 20089
Active, not recruiting
Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento
Verona, 31726
Active, not recruiting

Other trials in Italy

Spain11 sites

Hospital Universitario Vall d'Hebron
Barcelona, 08035
Active, not recruiting
Hospital de la Santa Creu i Sant Pau Barcelona
Barcelona, 08041
Withdrawn
Institut Catala d'Oncologia - L'Hospitalet
Barcelona, 08908
Active, not recruiting
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar, 30120
Withdrawn
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Active, not recruiting
Hospital Clinico San Carlos
Madrid, 28040
Active, not recruiting
Hospital Fundación Jiménez Díaz
Madrid, 28040
Active, not recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Active, not recruiting
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, 15706
Active, not recruiting
Hospital Universitario Virgen del Rocio
Seville, 41013
Active, not recruiting
Hospital Universitario Miguel Servet
Zaragoza, 50009
Withdrawn

Other trials in Spain

France8 sites

Institut Bergonie
Bordeaux, 33076
Active, not recruiting
Centre Oscar Lambret
Lille, 59000
Active, not recruiting
Centre Leon Berard
Lyon, 69008
Active, not recruiting
AP-HM - Hôpital de la Timone
Marseille, 13005
Active, not recruiting
Centre Eugene Marquis
Rennes, 35042
Active, not recruiting
ICO St-Herblain
Saint-Herblain, 44800
Active, not recruiting
CHU de Toulouse - Hospital Rangueil
Toulouse, 31400
Active, not recruiting
Gustave Roussy
Villejuif, 94805
Active, not recruiting

Other trials in France

United Kingdom7 sites

Cambridge Addenbrooke's Hospital
Cambridge, CB2 0QQ
Active, not recruiting
Beatson, West of Scotland Cancer Centre
Glasgow, G12 0YN
Withdrawn
University College London Hospital
London, NW1 2PG
Active, not recruiting
Guy's Hospital
London, SE1 9RT
Withdrawn
Royal Marsden Hospital - Surrey
London, SW3 6JJ
Active, not recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
Active, not recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2SJ
Active, not recruiting

Other trials in United Kingdom

Germany6 sites

Helios Klinikum Bad Saarow
Bad Saarow, 15526
Active, not recruiting
Helios Klinikum Berlin-Buch
Berlin, 13125
Active, not recruiting
Universitaetsklinikum Essen
Essen, 45147
Active, not recruiting
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246
Active, not recruiting
Medizinische Hochschule Hannover- Urology Oncology
Hanover, 30625
Active, not recruiting
Universitaetsmedizin Mannheim
Mannheim, 68167
Active, not recruiting

Other trials in Germany

South Korea5 sites

National Cancer Center
Goyang-si, Gyeonggi-do, 10408
Withdrawn
Seoul National University Hosptial
Seoul, 03080
Active, not recruiting
Asan Medical Center
Seoul, 05505
Active, not recruiting
Samsung Medical Center
Seoul, 06351
Active, not recruiting
Korea University Guro Hospital
Seoul, 08308
Active, not recruiting

Other trials in South Korea

Taiwan5 sites

Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung City, 83301
Active, not recruiting
National Taiwan University Hospital
New Taipei City, 10002
Active, not recruiting
China Medical University Hospital
Taichung, 40447
Active, not recruiting
Taipei Veterans General Hospital (VGHTP)
Taipei, 11217
Active, not recruiting
Chang Gung Memorial Hospital - Linkou Branch (CGMHLK)
Taoyuan, 33305
Active, not recruiting

Other trials in Taiwan

Canada4 sites

Tom Baker Cancer Center
Calgary, T2N 4N2
Active, not recruiting
Alberta Health Services Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Active, not recruiting
Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)
Montreal, HIT 2M4
Active, not recruiting
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Active, not recruiting

Other trials in Canada

Netherlands4 sites

Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)
Amsterdam, 1066 CX
Active, not recruiting
UMC Groningen
Groningen, 9713 GZ
Active, not recruiting
Stichting Radboud Universitair Medisch Centrum
Nijmegen, 6525 GA
Active, not recruiting
Erasmus MC
Rotterdam, 3015 GD
Active, not recruiting

Other trials in Netherlands

Poland4 sites

Szpital Specjalistyczny w Brzozowie
Brzozów, 36-200
Active, not recruiting
Centrum Onkologii im. Prof. Franciszka Lukaszczyka
Bydgoszcz, 85-796
Withdrawn
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach, Oddzial Chemioterapii Dziennej
Gliwice, 44-102
Active, not recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
Warsaw, 02-781
Active, not recruiting

Other trials in Poland

Brazil3 sites

Hospital das Clinicas da Universidade Estadual de Campinas (UNICAMP)
Campinas, 130.83-888
Active, not recruiting
lnstituto Nacional de Cancer - INCA
Rio de Janeiro, 20.230-130
Active, not recruiting
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
São Paulo, 09060-650
Active, not recruiting

Other trials in Brazil

Czechia3 sites

Masarykuv onkologicky ustav
Brno, 65653
Active, not recruiting
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
Withdrawn
Fakultni nemocnice Olomouc - Oncology clinic
Olomouc, 77900
Active, not recruiting

Other trials in Czechia

Hong Kong3 sites

Humanity & Health Clinical Trial Centre
Central
Withdrawn
Hong Kong United Oncology Centre
Jordon
Active, not recruiting
Prince of Wales Hospital
Shatin
Active, not recruiting

Other trials in Hong Kong

Mexico3 sites

Centro de Investigacion Medica Aquascalientes (CIMA)
Aguascalientes, 20116
Withdrawn
I Can Oncology Center SA De CV
Monterrey, 64710
Active, not recruiting
Oaxaca Site Management Organization S.C.
Oaxaca City, 68000
Withdrawn

Other trials in Mexico

Argentina2 sites

Instituto Alexander Fleming
Buenos Aires, C1426ANZ
Active, not recruiting
Instituto Oncologico de Cordoba (IONC)
Córdoba, X5000HWE
Active, not recruiting

Other trials in Argentina

Australia2 sites

Bankstown-Lidcombe Hospital
Bankstown, 2200
Active, not recruiting
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Active, not recruiting

Other trials in Australia

Chile2 sites

Instituto Oncologico FALP
Santiago, 7500921
Active, not recruiting
Centro de Oncologia de Precision, Universidad Mayor
Santiago, 7560908
Active, not recruiting

Other trials in Chile

Norway2 sites

Haukeland University Hospital - Bergen
Bergen, 5021
Active, not recruiting
Oslo University Hospital
Oslo, 0310
Active, not recruiting

Other trials in Norway

Sweden2 sites

Skane University Hospital Lund
Lund, 22185
Active, not recruiting
Karolinska University Hospital
Solna, 171 76
Active, not recruiting

Other trials in Sweden

Denmark1 site

Aarhus University Hospital
Aarhus, 8200
Active, not recruiting

Other trials in Denmark

Hungary1 site

Debreceni Egyetem, Klinikai Központ, Onkológiai Klinika
Debrecen, 4032
Active, not recruiting

Other trials in Hungary

About this study

Official title: A Phase 3 Randomized, Open-Label, Multicenter Clinical Study of CGT9486+Sunitinib vs. Sunitinib in Subjects With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors

This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 482 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent parts in approximately 20 patients who have received at least one prior line of therapy for Gastrointestinal Stromal Tumors (GIST) and 2) evaluating the potential for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388 patients who are intolerant to, or who failed prior treatment with imatinib only and will compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being randomized in a 1:1 manner. This study also contains two substudies: 1) a drug-drug interactions (DDI) substudy will investigate the potential for CGT9486 to be a Cytochrome P450 (CYP)3A4 inducer in approximately 16 patients who have received at least one prior line of therapy for GIST and 2) a substudy intended to test the efficacy of bezuclastinib and sunitinib as first-line (1L) treatment of GIST in approximately 40 participants with KIT exon 9 mutations and no prior systemic therapy (with the exception of up to 10 subjects with ongoing imatinib therapy of ≤4 weeks).

Conditions: Advanced Gastrointestinal Stromal Tumors, Metastatic Cancer
Being tested: CGT9486, Sunitinib, Midazolam
Keywords: Sunitinib, Solid Tumors, Gastrointestinal Stromal Tumors, Gastrointestinal, KIT, Kinase Inhibitors, Growth Inhibitors, CGT9486, Unresectable, Metastatic, GIST, Bezuclastinib, PLX9486, Midazolam, Drug-drug interaction
Medical subject headings: Neoplasm Metastasis, Gastrointestinal Stromal Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CGT9486Drug
Also called Bezuclastinib
Participants will receive CGT9486 orally until study stopping rules are met.
CGT9486Drug
Also called Bezuclastinib
Participants will receive CGT9486 until steady state then both CGT9486 and sunitinib orally until study stopping rules are met.
SunitinibDrug
Participants will receive sunitinib until steady state then both sunitinib and CGT9486 orally until study stopping rules are met.
SunitinibDrug
Participants will receive sunitinib orally until study stopping rules are met.
MidazolamDrug
Participants will receive a single-dose of midazolam on Day 1 and Day 16
CGT9486Drug
Participants will receive CGT9486 orally starting on Day 2 until study stopping rules are met.
SunitinibDrug
Participants will receive CGT9486 until steady state then both sunitinib and CGT9486 orally until study stopping rules are met.
CGT9486Drug
Also called Bezuclastinib
Participants will receive sunitinib until steady state then both CGT9486 and sunitinib orally until study stopping rules are met.
SunitinibDrug
Participants will receive sunitinib orally starting on Day 16 until study stopping rules are met.

Study groups in NCT05208047
Study group	Role	What they receive
Part 1a	Experimental	CGT9486 plus sunitinib 37.5 mg QD Receives: Drug: CGT9486; Drug: Sunitinib
Part 2 - Experimental Group	Experimental	CGT9486 plus sunitinib 37.5 mg QD Receives: Drug: CGT9486; Drug: Sunitinib
Part 2 - Control Group	Active comparator	sunitinib 37.5 mg QD Receives: Drug: Sunitinib
Part 1b - DDI Cohort 1	Experimental	CGT9486 plus sunitinib 37.5 mg QD Receives: Drug: CGT9486; Drug: Sunitinib
Part 1b - DDI Cohort 2	Experimental	sunitinib 37.5 mg QD plus CGT9486 Receives: Drug: Sunitinib; Drug: CGT9486
DDI Substudy (Midazolam)	Experimental	Midazolam, CGT9486, sunitinib Receives: Drug: Midazolam; Drug: CGT9486; Drug: Sunitinib
GIST 1L Substudy	Experimental	CGT9486, sunitinib Receives: Drug: CGT9486; Drug: Sunitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Part 1a - pharmacokinetics - Cmax
Maximum plasma concentration (Cmax)
Measured: 16 days
Part 1a - pharmacokinetics - AUC
Area under the plasma concentration-time curve (AUC)
Measured: 16 days
Part 1b - pharmacokinetics - Cmax
Maximum plasma concentration (Cmax)
Measured: 14 days
Part 1b - pharmacokinetics - AUC
Area under the plasma concentration-time curve (AUC)
Measured: 14 days
Part 1b - pharmacokinetics - Tmax
Time to maximum observed plasma concentration (Tmax)
Measured: 14 days
Part 2 - Progression Free Survival (PFS)
Time from first dose to documented disease progression or death due to any cause, whichever occurs first
Measured: Approximately 48 months
DDI Substudy - pharmacokinetics - AUC
Area under the plasma concentration-time curve (AUC)
Measured: 16 days
DDI Substudy - pharmacokinetics - Cmax
Maximum plasma concentration (Cmax)
Measured: 14 days

Secondary outcomes (10)

All Study Parts - observing the safety of each treatment regimen.
Incidence and severity of Adverse Events from first dose of study drug
Measured: Approximately 48 months
All Study Parts - observing the safety of each treatment regimen.
Incidence and severity of Serious Adverse Events from first dose of study drug
Measured: Approximately 48 months
All Study Parts - observing the safety of each treatment regimen.
Incidence of Adverse Events leading to dose modifications from first dose of study drug
Measured: Approximately 48 months
All Study Parts - observing the safety of each treatment regimen.
Change from baseline in laboratory results
Measured: Approximately 48 months
Part 1a, Part 1b, Part 2 - Overall Survival (OS)
Time from first dose to death due to any cause
Measured: Approximately 48 months
Part 1a, Part 1b, Part 2 - Objective Response Rate (ORR)
Percentage of subjects who achieved documented complete response (CR) + confirmed partial response (PR) based on modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Measured: Approximately 48 months
Part 1a, Part 1b, Part 2 - Disease Control Rate (DCR)
Percentage of subjects who achieved CR + PR + stable disease (SD) at 16 weeks
Measured: Approximately 48 months
Part 1a, Part 1b. Part 2 - Time to response (TTR)
Time from first dose to first documented response based on modified Response Evaluation Criteria in Solid Tumors Version 1.1
Measured: Approximately 48 months
Part 1a, Part 1b, Part 2 - Duration of Response (DOR)
Time from first response (CR or PR) to the date of progression or death from any cause, whichever occurs first
Measured: Approximately 48 months
Part 2 Only - European Organisation for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-30)
Change in individual scores in patients with locally advanced, unresectable, or metastatic GIST treated with CGT9486 in combination with sunitinib compared with patients treated with sunitinib monotherapy. The scale comprises 30 questions, 24 of which are aggregated into 9 multi-item scales, to include 5 functioning scales (physical, role, cognitive, emotional and social), 3 symptom scales (fatigue, pain and nausea/vomiting) and 1 global health status scale. The remaining 6 single-item scales assess symptoms (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea and the financial impact). All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning, while higher scores on the symptom and single-item scales indicate a higher level of symptoms.
Measured: Approximately 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Apr 2022Jan 2030

First posted26 Jan 2022
Study start14 Apr 2022
Primary completion30 Sep 2025
Study completionJan 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced 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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a multi-part study: Part 1a is a single-arm design, Part 1b is a two-arm parallel design drug-drug interaction evaluation in the first treatment cycle and single-arm design in subsequent treatment cycles, and Part 2 is a randomized two-arm parallel comparator study. The DDI substudy is a single-arm, fixed-sequence, crossover design to investigate the potential for CGT9486 to be a CYP3A4 inducer. The GIST 1L substudy is a single-arm study of bezuclastinib+sunitinib exploring efficacy in a 1L setting.
Masking: None (open label)
Enrolment: 482 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05208047
Sponsor's protocol ID: CGT9486-21-301
Status last verified: Jun 2026
First submitted: 23 Dec 2021
Last updated: 16 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Randomized, Open-Label, Multicenter Clinical Study of CGT9486+Sunitinib vs. Sunitinib in Subjects With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors
ClinicalTrials.gov ID: NCT05208047
Acronym / sponsor ID: CGT9486-21-301
Conditions: Advanced Gastrointestinal Stromal Tumors, Metastatic Cancer
Keywords: Sunitinib, Solid Tumors, Gastrointestinal Stromal Tumors, Gastrointestinal, KIT, Kinase Inhibitors, Growth Inhibitors, CGT9486
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 482 participants (estimated)
Lead sponsor: Cogent Biosciences, Inc.Industry (pharma, biotech, devices)
Study start: 14 Apr 2022 (actual)
Primary completion: 30 Sep 2025 (actual)
Study completion: Jan 2030 (estimated)
First posted: 26 Jan 2022 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 7
Model description: This is a multi-part study: Part 1a is a single-arm design, Part 1b is a two-arm parallel design drug-drug interaction evaluation in the first treatment cycle and single-arm design in subsequent treatment cycles, and Part 2 is a randomized two-arm parallel comparator study. The DDI substudy is a single-arm, fixed-sequence, crossover design to investigate the potential for CGT9486 to be a CYP3A4 inducer. The GIST 1L substudy is a single-arm study of bezuclastinib+sunitinib exploring efficacy in a 1L setting.

Arm	Type	Receives
Part 1a	Experimental	Drug: CGT9486, Drug: SunitinibCGT9486 plus sunitinib 37.5 mg QD
Part 2 - Experimental Group	Experimental	Drug: CGT9486, Drug: SunitinibCGT9486 plus sunitinib 37.5 mg QD
Part 2 - Control Group	Active comparator	Drug: Sunitinibsunitinib 37.5 mg QD
Part 1b - DDI Cohort 1	Experimental	Drug: CGT9486, Drug: SunitinibCGT9486 plus sunitinib 37.5 mg QD
Part 1b - DDI Cohort 2	Experimental	Drug: Sunitinib, Drug: CGT9486sunitinib 37.5 mg QD plus CGT9486
DDI Substudy (Midazolam)	Experimental	Drug: Midazolam, Drug: CGT9486, Drug: SunitinibMidazolam, CGT9486, sunitinib
GIST 1L Substudy	Experimental	Drug: CGT9486, Drug: SunitinibCGT9486, sunitinib

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Histologically confirmed locally advanced, metastatic, and/or unresectable GIST. Molecular pathology report must be available for Part 2; if molecular pathology report is unavailable or inadequate, an archival or fresh tumor tissue sample will be required to evaluate mutational status prior to randomization. (GIST 1L Substudy: must have documented mutation in KIT Exon 9 with an available molecular pathology report; archival or fresh tumor tissue sample will be required)
Documented disease progression on or intolerance to imatinib (Part 1a, Part 1b, Part 2, DDI Substudy)
Subjects must have received the following treatment:
Have at least 1 measurable lesion according to mRECIST v1.1 (Part1a, Part 1b, Part 2, GIST 1L Substudy)
Eastern Cooperative Oncology Group (ECOG) Status

Key exclusion criteria (9 listed)

Known Platelet-Derived Growth Factor Receptor (PDGFR) driving mutations or known succinate dehydrogenase deficiency (Part 1a, Part 1b, Part 2, DDI Substudy)
Clinically significant cardiac disease
Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug (Part 1a, Part 1b, Part 2, DDI Substudy)
Gastrointestinal abnormalities including, but not limited to, significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption
Any active bleeding excluding hemorrhoidal or gum bleeding

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
CGT9486Also: BezuclastinibParticipants will receive CGT9486 orally until study stopping rules are met.	Drug	GIST 1L Substudy, Part 1a, Part 2 - Experimental Group
CGT9486Also: BezuclastinibParticipants will receive CGT9486 until steady state then both CGT9486 and sunitinib orally until study stopping rules are met.	Drug	Part 1b - DDI Cohort 1
SunitinibParticipants will receive sunitinib until steady state then both sunitinib and CGT9486 orally until study stopping rules are met.	Drug	Part 1b - DDI Cohort 2
SunitinibParticipants will receive sunitinib orally until study stopping rules are met.	Drug	GIST 1L Substudy, Part 1a, Part 2 - Control Group, Part 2 - Experimental Group
MidazolamParticipants will receive a single-dose of midazolam on Day 1 and Day 16	Drug	DDI Substudy (Midazolam)
CGT9486Participants will receive CGT9486 orally starting on Day 2 until study stopping rules are met.	Drug	DDI Substudy (Midazolam)
SunitinibParticipants will receive CGT9486 until steady state then both sunitinib and CGT9486 orally until study stopping rules are met.	Drug	Part 1b - DDI Cohort 1
CGT9486Also: BezuclastinibParticipants will receive sunitinib until steady state then both CGT9486 and sunitinib orally until study stopping rules are met.	Drug	Part 1b - DDI Cohort 2
SunitinibParticipants will receive sunitinib orally starting on Day 16 until study stopping rules are met.	Drug	DDI Substudy (Midazolam)

Primary outcome

Part 1a - pharmacokinetics - Cmax
Time frame: 16 days
Maximum plasma concentration (Cmax)
Part 1a - pharmacokinetics - AUC
Time frame: 16 days
Area under the plasma concentration-time curve (AUC)
Part 1b - pharmacokinetics - Cmax
Time frame: 14 days
Maximum plasma concentration (Cmax)
Part 1b - pharmacokinetics - AUC
Time frame: 14 days
Area under the plasma concentration-time curve (AUC)
Part 1b - pharmacokinetics - Tmax
Time frame: 14 days
Time to maximum observed plasma concentration (Tmax)
Part 2 - Progression Free Survival (PFS)
Time frame: Approximately 48 months
Time from first dose to documented disease progression or death due to any cause, whichever occurs first
DDI Substudy - pharmacokinetics - AUC
Time frame: 16 days
Area under the plasma concentration-time curve (AUC)
DDI Substudy - pharmacokinetics - Cmax
Time frame: 14 days
Maximum plasma concentration (Cmax)

10 secondary outcomes

All Study Parts - observing the safety of each treatment regimen.
Time frame: Approximately 48 months
All Study Parts - observing the safety of each treatment regimen.
Time frame: Approximately 48 months
All Study Parts - observing the safety of each treatment regimen.
Time frame: Approximately 48 months
All Study Parts - observing the safety of each treatment regimen.
Time frame: Approximately 48 months
Part 1a, Part 1b, Part 2 - Overall Survival (OS)
Time frame: Approximately 48 months
Part 1a, Part 1b, Part 2 - Objective Response Rate (ORR)
Time frame: Approximately 48 months
Part 1a, Part 1b, Part 2 - Disease Control Rate (DCR)
Time frame: Approximately 48 months
Part 1a, Part 1b. Part 2 - Time to response (TTR)
Time frame: Approximately 48 months
Part 1a, Part 1b, Part 2 - Duration of Response (DOR)
Time frame: Approximately 48 months
Part 2 Only - European Organisation for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-30)
Time frame: Approximately 48 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
Individual participant dataSharing planned: No

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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.

Cogent Biosciences contact

617-945-5576

peakinfo@cogentbio.com

126 sites in 22 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CGT9486, Sunitinib and Midazolam in people with Advanced Gastrointestinal Stromal Tumors and Metastatic Cancer, run by Cogent Biosciences, Inc. at 126 sites in 22 countries.

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 12 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 126 sites in United States, Italy, Spain, France, United Kingdom and 17 more countries. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cogent Biosciences (617-945-5576, peakinfo@cogentbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1a - pharmacokinetics - Cmax (time frame: 16 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05208047.

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 16 Jun 2026.