Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT06014502
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2023-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid Tumors
Sponsor:
ImmunoGenesis
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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 been treated with each of these doses. Approximately 25 total subjects will be enrolled in Phase 1a.
Part 2 is a Phase 1b, open-label, dose-expansion study of five prespecified tumor cohorts to assess preliminary antitumor activity of IMGS-001 in patients that are refractory or intolerant to other appropriate prior standard therapies. Initially, up to 10 subjects in each of the following cohorts will be treated:
Cohort 1: Ovarian cancer; Cohort 2: Colorectal cancer (microsatellite stable; PD-L1 positive \[CPS ≥ 5 or TPS ≥ 5%\]); Cohort 3: Non-small cell lung cancer (EGFR wild-type); Cohort 4: Nasopharyngeal cancer; Cohort 5: Head and neck/cervical (HPV positive).
Each cohort will be assessed to meet efficacy criteria to continue into a randomized dose-optimization. Within each cohort that meets prespecified efficacy criteria, the expanded cohorts will have randomly assigned (1:1) subjects to receive one of two doses used in the Phase 1a. Within each Arm, 20 eligible subjects will be treated with the assigned dose of IMGS-001.
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 been treated with each of these doses. Approximately 25 total subjects will be enrolled in Phase 1a.
Part 2 is a Phase 1b, open-label, dose-expansion study of five prespecified tumor cohorts to assess preliminary antitumor activity of IMGS-001 in patients that are refractory or intolerant to other appropriate prior standard therapies. Initially, up to 10 subjects in each of the following cohorts will be treated:
Cohort 1: Ovarian cancer; Cohort 2: Colorectal cancer (microsatellite stable; PD-L1 positive \[CPS ≥ 5 or TPS ≥ 5%\]); Cohort 3: Non-small cell lung cancer (EGFR wild-type); Cohort 4: Nasopharyngeal cancer; Cohort 5: Head and neck/cervical (HPV positive).
Each cohort will be assessed to meet efficacy criteria to continue into a randomized dose-optimization. Within each cohort that meets prespecified efficacy criteria, the expanded cohorts will have randomly assigned (1:1) subjects to receive one of two doses used in the Phase 1a. Within each Arm, 20 eligible subjects will be treated with the assigned dose of IMGS-001.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: