Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid Tumors (NCT06014502) | Clinical Trial Compass
RecruitingPhase 1
Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid Tumors
United States105 participantsStarted 2023-09-07
Plain-language 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
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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. Must be naïve to treatment with PD-1 and PD-L1 targeting agents.
✓. Non-small cell lung (EGFR wild-type): Failed or intolerant to prior lines of appropriate SOC chemotherapy and targeted therapy regimens. Failed, did not respond, or intolerant to prior immune checkpoint therapy (e.g., anti-PD-1).
✓. Nasopharyngeal: Failed or intolerant to prior lines of appropriate SOC chemotherapy and targeted therapy regimens. Failed, did not respond, or intolerant to prior immune checkpoint therapy (e.g., anti-PD-L1).
✓. Head and neck/cervical (HPV positive): Failed or intolerant to prior lines of appropriate SOC chemotherapy and targeted therapy regimens. Failed, did not respond, or intolerant to prior immune checkpoint therapy (e.g., anti-PD-L1).
✓. Received at least 2 doses of an approved or investigational anti PD-1 or anti-PD-L1 inhibitor.
✓. Last dose of therapy must have been ≥ 28 days prior to Cycle 1 Day 1.
✓
What they're measuring
1
Phase 1a- Safety and tolerability of IMGS-001 by dose-limiting toxicities and adverse events
Timeframe: 21 days
2
Phase 1b- Recommended Phase 2 dose (RP2D) of IMGS-001 for specified tumor-specific cohorts as a pharmacologically optimal dose (POD)
. Eligible patients include those patients treated with anti PD-1/anti PD-L1 drugs who have progressed following response to prior therapy, and those that have failed to demonstrate any response to prior therapy.