Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Part A: Dose Escalation Multiple doses of CGT4255 for oral administration |
|
| Signal Seeking and Dose Escalation | Experimental | Part B: Signal Seeking and Dose Optimization Oral dose(s) of CGT4255 at the selected dose levels determined in Phase 1 |
|
| Signal Seeking | Experimental | Part C: Includes signal seeking. Participants will receive CGT4255 at a dose level selected based on data from Part A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGT4255 | Drug | CGT4255 Daily Oral Administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Part A] | 1. Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) and AEs leading to dose modifications and dose limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD) or the maximum evaluated dose (MED) in participants with ERBB2-altered advanced solid tumors | Approximately 12 months |
| Overall Response Rate [Part B and Part C] | Overall Response Rate (ORR), determined by confirmed CR + PR of all lesions (intracranial and extracranial), based on Investigator assessment using the whole-body RECIST v1.1 in participants with ERBB2-mutated NSCLC with Brain Metastases (BM) and in participants with ERBB2-mutated or HER2-positive breast cancer with BM ± leptomeningeal disease (LMD) | Approximately 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Part B and C] | Incidence and grade of Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to dose modification in participants with ERBB2-mutated NSCLC with Brain Metastases (BM) and in participants with ERBB2-mutated or HER2-positive breast cancer with BM ± leptomeningeal disease (LMD) | Approximately 7 months |
Not provided
Inclusion Criteria:
Have histologically confirmed diagnosis of:
Have measurable disease per RECIST v1.1.
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.
Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cogent Biosciences, Inc | Contact | 617-945-5576 | trialinfo@cogentbio.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| START Midwest | Recruiting | Grand Rapids | Michigan | 49546 | United States | |
| NYU Langone |
Not provided
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)
Not provided
Not provided
Not provided
Not provided
| Pharmacokinetics [Part A] | Area under the concentration-time curve (AUC) in participants with ERBB2 altered advanced solid tumors | Approximately 28 days |
| Pharmacokinetics [Part A] | Maximum observed concentration (Cmax) in participants with ERBB2 altered advanced solid tumors | Approximately 28 days |
| Pharmacokinetics [Part A] | Observed concentration at pre-dose (Ctrough) | Approximately 28 days |
| Pharmacokinetics [Part A) | Time to measure concentration (Tmax) | Approximately 28 days |
| Disease Response [Part A] | Overall objective response rate (ORR), as determined by confirmed complete response (CR) + confirmed partial response (PR) of all lesions (intracranial and extracranial) based on Investigator assessment using whole-body Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Approximately 6 months |
| Disease Response [Part A] | Disease control rate (DCR), as determined by overall confirmed CR + confirmed PR + stable disease (SD) based on Investigator assessment using whole-body RECIST v1.1 | Approximately 6 months |
| Disease Response [Part B and Part C] | Disease Control Rate (DCR), determined by overall confirmed CR + confirmed PR +SD based on Investigator assessment using whole body RECIST v1.1 | Approximately 6 months |
| Disease Response [Part B and Part C] | Duration of Response (DOR), defined as time from first confirmed response (CR or PR) to the date of progressive disease (PD) or death from any cause, whichever occurs earlier | Approximately 6 months |
| Disease Response [Part B and Part C] | Progression- free survival (PFS), defined as the time from the date of the first dose of study drug (Part B run-in and Part C)/ randomization (Part B randomized cohort) until the date of PD, based on Investigator assessment using whole body RECIST v1.1, or death from any cause, whichever comes earlier | Approximately 6 months |
| Recruiting |
| New York |
| New York |
| 10016 |
| United States |
| Tennessee Oncology | Recruiting | Nashville | Tennessee | 37203 | United States |
| NEXT Oncology Texas | Recruiting | Austin | Texas | 78758 | United States |
| START Mountain Region | Recruiting | West Valley City | Utah | 84119 | United States |
| NEXT Oncology Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided