Cogent Biosciences

🇺🇸United States

Country: 🇺🇸United States

Ownership: Public

Established: 2014-01-01

Employees: 164

Market Cap: $1B

Website: http://www.cogentbio.com

Introduction: Cogent Biosciences, Inc. is a biotechnology company, which engages in the development of precision therapies for genetically defined diseases. It focuses on CGT9486, a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. The company was founded by Charles Wilson and Dario Campana in March 2014 and is headquartered in Waltham, MA.

Clinical Trials

Active:10

Completed:2

Trial Phases

3 Phases

Phase 1:15

Phase 2:4

Phase 3:1

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (20 trials with phase data)• Click on a phase to view related trials

Phase 1

15 (75.0%)

Phase 2

4 (20.0%)

Phase 3

1 (5.0%)

Expanded Access to Bezuclastinib to be Coadministered With Sunitinib for Patients With Gastrointestinal Stromal Tumors

Conditions: Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors

First Posted Date: 2025-04-29

Last Posted Date: 2025-05-04

Lead Sponsor: Cogent Biosciences, Inc.

Registration Number: NCT06948955

Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis

Conditions: Systemic Mastocytoses, Indolent
Systemic Mastocytoses, Aggressive

First Posted Date: 2025-04-08

Last Posted Date: 2025-04-08

Lead Sponsor: Cogent Biosciences, Inc.

Registration Number: NCT06915766

A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Intrahepatic Cholangiocarcinoma (Icc)
Cholangiocarcinoma
Other Solid Tumors, Adult
FGFR2 Gene Fusion/Rearrangement
FGFR2 Gene Amplification
FGFR2 Gene Short Variants
FGFR3 Gene Fusion/Rearrangement
FGFR3 Gene Amplification
FGFR3 Gene Short Variants
FGFR2 Genetic Alterations

Interventions: Drug: CGT4859

First Posted Date: 2025-01-15

Last Posted Date: 2025-05-04

Lead Sponsor: Cogent Biosciences, Inc.

Target Recruit Count: 110

Registration Number: NCT06777316

Locations: 🇺🇸
Fox Chase cancer Center, Philadelphia, Pennsylvania, United States
🇨🇦
Cross Cancer Institute, Edmonton, Alberta, Canada
🇺🇸
Stanford Cancer Institute, Palo Alto, California, United States

and more 7 locations

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

Phase 3

Active, not recruiting

Conditions: Advanced Gastrointestinal Stromal Tumors
Metastatic Cancer

Interventions: Drug: CGT9486 plus sunitinib
Drug: Sunitinib
Drug: CGT9486
Drug: Midazolam

First Posted Date: 2022-01-26

Last Posted Date: 2025-05-09

Lead Sponsor: Cogent Biosciences, Inc.

Target Recruit Count: 442

Registration Number: NCT05208047

Locations: 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸
Mayo Clinic, Rochester, Minnesota, United States
🇺🇸
University of Arizona- Cancer Center, Tucson, Arizona, United States

and more 122 locations

(Summit) a Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients with Indolent or Smoldering Systemic Mastocytosis

Phase 2

Active, not recruiting

Conditions: SSM
Mastocytosis, Indolent
Mastocytosis, Systemic
Mastocytosis
ISM
BMM
Smoldering Systemic Mastocytosis
Bone Marrow Mastocytosis

Interventions: Drug: Bezuclastinib Tablets (Formulation B)
Drug: Bezuclastinib Tablets (Formulation A)
Drug: Placebo Tablets

First Posted Date: 2022-01-11

Last Posted Date: 2025-01-10

Lead Sponsor: Cogent Biosciences, Inc.

Target Recruit Count: 207

Registration Number: NCT05186753

Locations: 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸
Mayo Clinic Arizona, Phoenix, Arizona, United States
🇺🇸
One of a Kind Clinical Research Center, Scottsdale, Arizona, United States

and more 66 locations

News

Bezuclastinib Achieves 87% Response Rate in Pivotal Trial for Non-Advanced Systemic Mastocytosis

6 days ago

Cogent Biosciences' bezuclastinib demonstrated superior symptom improvement with a placebo-adjusted difference of 8.91 points in total symptom score at 24 weeks (p=0.0002) in the SUMMIT trial.