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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
IMGS-001
DrugEvery 2 weeks
Treatment groups
105 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Phase 1a Solid TumorsExperimental treatment 1 intervention
Group B: Phase 1b Ovarian CancerExperimental treatment 1 intervention
Group C: Phase 1b Colorectal Cancer (Microsatellite Stable; PD-L1 Positive [CPS ≥ 5 or TPS ≥ 5%])Experimental treatment 1 intervention
Group D: Phase 1b Non-small Cell Lung Cancer (EGFR Wild-type)Experimental treatment 1 intervention
Group E: Phase 1b Nasopharyngeal CancerExperimental treatment 1 intervention
Group F: Phase 1b Head and Neck/Cervical Cancer (HPV positive)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Phase 1a- Safety and tolerability of IMGS-001 by dose-limiting toxicities and adverse events
Frequency and severity of dose limiting toxicities and adverse events
Time frame
21 days2
Phase 1b- Recommended Phase 2 dose (RP2D) of IMGS-001 for specified tumor-specific cohorts as a pharmacologically optimal dose (POD)
RP2D will be defined by pooling all available PK, PD, target engagement, efficacy, safety, and tolerability data from Part 1 and Part 2
Time frame
12 monthsSecondary outcomes
1
Phase 1a- Maximum tolerable dose (MTD) of IMGS-001
Time frame
12 months2
Pharmacokinetics (PK) of IMGS-001 by terminal half life (t1/2)
Time frame
12 months3
Pharmacokinetics of IMGS-001 by Area Under the Curve (AUC)
Time frame
12 months4
Pharmacokinetics of IMGS-001 by Maximum Observed Concentration (Cmax)
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov