Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Soli
The purpose of this Phase 1a/1b clinical trial is to test the safety of an investigational drug called IMGS-001 and to determine how well it can work in treating patients with advanced solid tumors that have come back or are not improving after receiving other drugs that are commonly used for their cancer. Phase 1a (Pa
| Condition(s) | Solid Tumor |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | The purpose of this Phase 1a/1b clinical trial is to test the safety of an investigational drug called IMGS-001 and to determine how well it can work in treating patients with advanced solid tumors that have come back or are not improving after receiving other drugs that are commonly used for their cancer. Phase 1a (Part 1) will test the safety of five different doses of IMGS-001 to use in further studies. Patients with cancer that have advanced or spread to other parts of the body following treatment with other available therapies will be treated in Part 1. Phase 1b (Part 2) will test two doses of IMGS-001 identified in Part 1 to further determine the safety and potential effectiveness in select cancer types. |
| Who can participate | Inclusion Criteria: * Part 1 Dose-escalation: Patients must have histologically confirmed locally advanced, or metastatic solid tumors who have progressed after receiving appropriate lines of standard therapy known to potentially confer clinical benefit. * Part 2 Dose-expansion: Patients must have histologically confirmed locally advanced, or metastatic cancer in one of the following pre-specified tumor types and meet tumor-specific criteria: 1. Ovarian: Failed or intolerant to prior lines of appropriate SOC chemotherapy and targeted therapy regimens. Must be naïve to treatment with PD-1 and PD-L1 targeting agents. 2. Colorectal (microsatellite stable; PD-L1 positive \[CPS ≥ 5 or TPS ≥ 5%\]): Failed or intolerant to prior lines of appropriate SOC chemotherapy and targeted therapy regimens. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | ImmunoGenesis |
| Locations | Gilbert, Arizona, United States; Santa Monica, California, United States; Edgewood, Kentucky, United States; New Orleans, Louisiana, United States; Houston, Texas, United States; Irving, Texas, United States |
| Start date | 2023-09-07 |
| NCT ID | NCT06014502 |
| Official listing | https://clinicaltrials.gov/study/NCT06014502 |