Actively Recruiting
Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid Tumors
Led by ImmunoGenesis · Updated on 2026-05-08
105
Participants Needed
6
Research Sites
220 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Histologically confirmed locally advanced or metastatic solid tumors that progressed after appropriate standard therapies
- For Phase 1b, cancers must be one of the following: ovarian, colorectal (microsatellite stable, PD-L1 positive), non-small cell lung (EGFR wild-type), nasopharyngeal, or head and neck/cervical (HPV positive)
- Patients must have failed or be intolerant to prior standard chemotherapy and targeted therapies
- For prostate cancer patients in Part 1, must continue androgen deprivation therapy or have undergone surgical/medical castration with low serum testosterone
- Patients in cohorts with prior immune checkpoint therapy must have received at least 2 doses, with last dose at least 28 days before treatment start
- Colorectal patients in Phase 1b must have confirmed PD-L1 positive expression within 6 months
- ECOG performance status 0-1
- Life expectancy greater than 3 months
- At least one measurable lesion per RECIST 1.1
- Must have biopsy-accessible non-target lesion or archival tumor tissue within 6 months
- Adequate bone marrow and organ function as defined by specific blood counts and liver/kidney tests
You will not qualify if you...
- Received any investigational or conventional anti-cancer drug or therapy within 21 days before treatment
- Use of immunosuppressive medication within 14 days before treatment, except inhaled or intranasal corticosteroids
- Use of interleukin-2, interferon, or other immunotherapy within 28 days before treatment
- Live vaccine within 28 days before treatment
- Unresolved toxicities from prior therapies above Grade 1, except alopecia
- Prior severe toxicity (Grade 3 or 4) from anti-PD-1 or anti-PD-L1 treatments leading to discontinuation
- Secondary malignancy other than target cancer within last 2 years
- Recent serious heart conditions or thrombotic events within 3 months
- History of gastrointestinal conditions increasing risk of bowel perforation
- Active, uncontrolled, or prior autoimmune disorders requiring immunosuppressive therapy
- Uncontrolled illness or infection that may interfere with study compliance
- Active HIV infection unless well-controlled on antiretroviral therapy
- Active or chronic hepatitis B or C infection not controlled or treated
- History of solid organ transplantation
- Untreated or unstable cancer-related central nervous system disease
- Major surgery or significant injury within 28 days before treatment
- Abnormal lung function or serious pulmonary conditions within 6 months
- History of severe infusion-related reactions to prior therapies
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
Actively Recruiting
3
St. Elizabeth Healthcare
Edgewood, Kentucky, United States, 41017
Actively Recruiting
4
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Actively Recruiting
5
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
6
NEXT Dallas
Irving, Texas, United States, 75039
Actively Recruiting
Research Team
C
Charles Schweizer, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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