Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmunoGenesis
About this trial
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.
Eligibility criteria
Qualifiers
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.
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).
Disqualifiers
Receipt of any investigational or conventional anti-cancer drug/therapy within 21 days of Cycle 1 Day 1.
Current or prior use of immunosuppressive medication within 14 days of Cycle 1 Day 1. Inhaled and intranasal corticosteroids are allowed.
Current or prior use of interleukin-2, interferon, or other immunotherapy medication within 28 days of Cycle 1 Day 1.
Live vaccine within 28 days prior to Cycle 1 Day 1.
Trial design
Treatments tested in this trial
- IMGS-001
Treatment groups
105 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov