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.

Nasopharyngeal: non-keratinizing; ≤ 2 prior lines of therapy in relapse setting; patients should have received prior chemotherapy and/or immune checkpoint blockade as per SOC.

9p24.1 Lymphomas (classic Hodgkin's, PMBCL): post first line therapy and completion of salvage regimens (including ASCT) with curative intent per SOC.

Ovarian (high-grade epithelial, fallopian tube, or primary peritoneal): platinum resistant disease defined as progression within < 6 months from completion of a platinum-based chemotherapy regimen; platinum refractory subjects are excluded (defined as disease that has recurred/progressed while receiving platinum-based frontline therapy). ≤ 3 prior lines of therapy in relapse setting; may be naive or exposed to prior checkpoint therapy; may have received prior folate receptor alpha (FRα) antibody-drug conjugate (ADC), other targeted therapies, and/or PARPi as appropriate per SOC; confirmed PD-L1 CPS ≥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 except those required in the protocol pre-medication regimen. 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 groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators