A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors
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
- Advanced Solid Tumor, Adult
- ERBB2 Altered Breast Cancer
- ERBB2 Gene Amplification
- HER2 Overexpression
- Non-Small Cell Lung Cancer
- HER2
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
HonorHealth Research Institute
Scottsdale, Arizona 85258
Scottsdale, Arizona 85258
Mayo Scottsdale
Scottsdale, Arizona 85281
Scottsdale, Arizona 85281
Yale Cancer Center
New Haven, Connecticut 06510
New Haven, Connecticut 06510
Mayo Jacksonville
Jacksonville, Florida 32209
Jacksonville, Florida 32209
Northwestern University
Chicago, Illinois 60611
Chicago, Illinois 60611
LSU Health Sciences Center School of Medicine
New Orleans, Louisiana 70803
New Orleans, Louisiana 70803
START Midwest
Grand Rapids, Michigan 49546
Grand Rapids, Michigan 49546
Mayo Rochester
Rochester, Minnesota 55905
Rochester, Minnesota 55905
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri 63110
St Louis, Missouri 63110
START NY Long Island
Lake Success, New York 11042
Lake Success, New York 11042
NYU Langone
New York, New York 10016
New York, New York 10016
Tennessee Oncology
Nashville, Tennessee 37203
Nashville, Tennessee 37203
NEXT Oncology Texas
Austin, Texas 78758
Austin, Texas 78758
START Mountain Region
West Valley City, Utah 84119
West Valley City, Utah 84119
NEXT Oncology Virginia
Fairfax, Virginia 22031
Fairfax, Virginia 22031
More Details
- Status
- Recruiting
- Sponsor
- Cogent Biosciences, Inc.