A Phase 1a/1b, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of IMGS-001 in Patients With Relapsed or Refractory Advanced Solid Tumors
ImmunoGenesis
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.
Description
Part 1 is a Phase 1a, first-in-human, open-label dose-escalation study to determine the safety, tolerability, and maximum tolerated dose (MTD) of IMGS-001. The safety, tolerability, PK parameters, and preliminary antitumor activity of IMGS-001 will be assessed in adult patients with advanced solid tumors refractory to appropriate standard of care (SOC) treatments. Based on the MTD and other information (e.g., tolerability, PK, PD, target engagement), two doses of IMGS-001 will be selected for further evaluation. Additional subjects will be backfilled until at least 10 evaluable subjects have…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 a…
Interventions
- DrugIMGS-001
Every 2 weeks
Locations (6)
- Banner MD Anderson Cancer CenterGilbert, Arizona
- Sarcoma Oncology CenterSanta Monica, California
- St. Elizabeth HealthcareEdgewood, Kentucky
- Ochsner Clinic FoundationNew Orleans, Louisiana
- MD Anderson Cancer CenterHouston, Texas
- NEXT DallasIrving, Texas