A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors

Part of paid clinical trials in Grand Rapids, Michigan.

Sponsor
Cogent Biosciences, Inc.
Study ID
NCT07361562
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • CGT4255 — DRUG
    CGT4255 Daily Oral Administration

Study Details

This is an open-label, phase 1/1b study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4255 in adult participants with advanced solid tumors with ERBB2 alterations or HER2 overexpression.

Key Dates

Start date
Dec 30, 2025
Status verified
Feb 2026
Primary completion
May 31, 2028
Completion
Nov 30, 2028

Study Design

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

Arms

  • Experimental: Dose Escalation
    Part A: Dose Escalation Multiple doses of CGT4255 for oral administration
  • Experimental: Signal Seeking and Dose Escalation
    Part B: Signal Seeking and Dose Optimization Oral dose(s) of CGT4255 at the selected dose levels determined in Phase 1
  • Experimental: Signal Seeking
    Part C: Includes signal seeking. Participants will receive CGT4255 at a dose level selected based on data from Part A

Primary Outcome Measure

Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Part A] [ Time Frame: Approximately 12 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
START MidwestGrand RapidsMichigan49546-
NYU LangoneNew YorkNew York10016-
Tennessee OncologyNashvilleTennessee37203-
NEXT Oncology TexasAustinTexas78758-
START Mountain RegionWest Valley CityUtah84119-
NEXT Oncology VirginiaFairfaxVirginia22031-

Find similar trials in Grand Rapids, MI

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
START Midwest· Grand Rapids, MINYU Langone· New York, NYTennessee Oncology· Nashville, TNNEXT Oncology Texas· Austin, TXSTART Mountain Region· West Valley City, UTNEXT Oncology Virginia· Fairfax, VA

Related Studies