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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Have histologically confirmed diagnosis of: 1. Part A: Locally advanced, metastatic, and/or unresectable solid tumor with documented ERBB2-activating alteration or NRG1 gene fusion in blood and/or tumor or HER2 overexpression in tumor 2. Part B: Locally advanced, metastatic, and/or unresectable NSCLC with documented ERBB2 mutation in blood and/or tumor 3. Part C: Locally advanced, metastatic and/or unresectable breast cancer with documented ERBB2 mutation in blood and/or tumor or HER overexpression in tumor 2. Have measurable disease per RECIST v1.1. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1 for Part A. For Parts B and C, ECOG Performance Status must be 0 to 2. 4. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits.

Exclusion Criteria

  1. Received small molecule chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug. 2. Major surgeries (eg, craniotomy and thoracotomy) within 4 weeks of the first dose of study drug. 3. Treatment with palliative focal radiotherapy (cranial or extracranial) (eg, stereotactic radiosurgery or intensity-modulated radiation therapy) ≤2 weeks before the first dose of study drug; treatment with whole-brain radiotherapy ≤4 weeks before the first dose of study drug. 4. Clinically significant cardiac disease. 5. Resolution of toxicities from prior therapy to ≤Grade 1 (or baseline), including resolution of clinically significant laboratory abnormalities, before the first dose of study drug. 6. Restrictions on use of corticosteroid use to manage neurologic symptoms in different parts of the study.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Phase 1, Part A evaluating multiple ascending doses. Phase 1b, evaluation of Part A selected doses in 2 cohorts defined by tumor type including a randomized dose optimization design (Part B)
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Escalation 		Part A: Dose Escalation Multiple doses of CGT4255 for oral administration
  • Drug: CGT4255
    CGT4255 Daily 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
  • Drug: CGT4255
    CGT4255 Daily Oral Administration
Experimental
Signal Seeking 		Part C: Includes signal seeking. Participants will receive CGT4255 at a dose level selected based on data from Part A
  • Drug: CGT4255
    CGT4255 Daily Oral Administration

Recruiting Locations

HonorHealth Research Institute
Scottsdale, Arizona 85258

Mayo Scottsdale
Scottsdale, Arizona 85281

Yale Cancer Center
New Haven, Connecticut 06510

Mayo Jacksonville
Jacksonville, Florida 32209

Northwestern University
Chicago, Illinois 60611

LSU Health Sciences Center School of Medicine
New Orleans, Louisiana 70803

START Midwest
Grand Rapids, Michigan 49546

Mayo Rochester
Rochester, Minnesota 55905

Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri 63110

START NY Long Island
Lake Success, New York 11042

NYU Langone
New York, New York 10016

Tennessee Oncology
Nashville, Tennessee 37203

NEXT Oncology Texas
Austin, Texas 78758

START Mountain Region
West Valley City, Utah 84119

NEXT Oncology Virginia
Fairfax, Virginia 22031

More Details

Status
Recruiting
Sponsor
Cogent Biosciences, Inc.

Study Contact

Cogent Biosciences, Inc
617-945-5576
trialinfo@cogentbio.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.