Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07361562 | A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors | PHASE1 | RECRUITING | 100 | — | — | Dec 30, 2025 | Nov 1, 2028 | Feb 27, 2026 | 6 | United States |
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
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)
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| CGT4255 | DRUG | CGT4255 Daily Oral Administration |
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, metas...