A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Cogent Biosciences, Inc.
Study ID
NCT07383506
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumors, Adult
  • Endometrial Cancer
  • HER2-low Breast Cancer
  • HR Positive/HER-2 Negative Breast Cancer
  • PIK3CA Mutations

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CGT6297 — DRUG
    CGT6297 Daily Oral Administration

Study Details

This is a Phase 1, two-part, open-label, nonrandomized, dose-escalation and signal-seeking study of CGT6297, evaluating the safety, tolerability, PK, pharmacodynamic (what the drug does to the body), and antitumor activity of CGT6297 in adult participants with advanced solid tumors harboring PIK3CA mutations

Key Dates

First listed
Feb 3, 2026
Start date
Jul 23, 2026
Status verified
Aug 2026
Primary completion
Jul 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    Part 1a: Dose Escalation of Multiple doses of CGT6297 for oral administration
  • Experimental: Signal Seeking
    Phase 1b: Participants will receive CGT6297 at a dose level selected based on data from Phase 1a

Primary Outcome Measure

Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Phase 1a] [ Time Frame: Approximately 12 months ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
HonorHealth Research InstituteScottsdaleArizona85258-
START Los AngelesLos AngelesCalifornia90025-
Sarah Cannon Research Institute (SCRI) at HealthONE-DenverDenverColorado80218-
H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.TampaFlorida33612-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Washington University School of Medicine - Siteman Cancer CenterSt LouisMissouri63110-
START New Jersey, LLCEast BrunswickNew Jersey08816-
SCRI Oncology Partners - NashvilleNashvilleTennessee01071-
NEXT AustinAustinTexas78758-
START Mountain Region, LLCWest Valley CityUtah84119-
NEXT VirginiaFairfaxVirginia22031-

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By research site
HonorHealth Research Institute· Scottsdale, AZSTART Los Angeles· Los Angeles, CASarah Cannon Research Institute (SCRI) at HealthONE-Denver· Denver, COH. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.· Tampa, FLDana-Farber Cancer Institute· Boston, MAWashington University School of Medicine - Siteman Cancer Center· St Louis, MO

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