Study of IMGS-001 for Advanced Solid Tumors
This study is testing a new drug called IMGS-001 for people with advanced solid tumors that have either come back or are not responding to standard treatments. The main goals are to find a safe dose of IMGS-001 and see how well it works. In the first part (Phase 1a), researchers will test different doses of IMGS-001 to find the safest one. In the second part (Phase 1b), they will further study the safety and potential benefits of IMGS-001 in specific types of cancer. You may be able to join if you are 18 or older and have certain advanced solid tumors that have progressed after other treatments. This study is currently unclear if it is recruiting new participants.
- Study design
- This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It is a Phase 1a/1b study, aiming to enroll about 105 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess the recommended Phase 2 dose of IMGS-001 at 12 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06014502
Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid Tumors
Recruiting
PHASE1Ages 18+InterventionalTreatmentImmunoGenesis
~105 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:IMGS-001
At a glance
Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1a- Safety and tolerability of IMGS-001 by dose-limiting toxicities and adverse events
Measured over 21 days
+1 more outcome measured
Conditions
Where it's being run
11 sites across 8 statesCalifornia2
Pennsylvania2
Texas2
Arizona1
Florida1
Kentucky1
Louisiana1
Missouri1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
Part 2 Dose-expansion: Patients must have histologically confirmed locally advanced, or metastatic cancer in one of the following pre-specified tumor types and meet tumor-specific criteria:
Patients eligible to enroll in cohorts with prior immune checkpoint therapy must meet the following criteria:
Ovarian cancer, HNSCC, and NSCLC patients participating in Part 2 (Phase 1b) must have confirmed PD-L1 positive expression (CPS ≥ 1 or TPS ≥ 50% \[NSCLC only\]).
Male or female ≥ 18 years of age.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Life expectancy \> 3 months.
At least 1 measurable lesion as defined by RECIST 1.1. Subjects with lymphoma must have measurable disease as per Lugano Criteria (2014).
Patients must have a non-target lesion that can be biopsied. If a patient only has one target lesion (and no non-target lesions) the target lesion used for biopsy must be ≥ 2 cm in longest diameter.
Patients must have adequate bone marrow and organ function as defined by:
Exclusion
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.
Any toxicity from prior standard therapy that has not resolved to ≤ Grade 1 or baseline per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 at the time of consent. Alopecia is an exception. Any patients with irreversible Grade 1 or Grade 2 toxicities that are considered stable may be enrolled after discussion with the Medical Monitor.
Prior anti-PD-1 or anti-PD-L1-related Grade 3 or Grade 4 toxicity resulting in treatment discontinuation of the drug.
Secondary malignancy other than the target malignancy to be investigated in this trial within the last 2 years. Subjects with a history of carcinoma in situ, basal cell carcinoma and other malignancies with low risk of recurrence, that have been curatively treated and have not progressed, and are under surveillance may be enrolled.
History of myocardial infarction, ischemic heart disease, symptomatic congestive heart failure (New York Heart Association (NYHA) Class III IV), or significant cardiac arrhythmias within 3 months of study enrollment.
Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) or pulmonary embolism within 3 months of study enrollment.
History of acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal carcinomatosis, bowel perforation, or other known risk factors for bowel perforation.
Active, uncontrolled, or prior documented autoimmune disorders including but not limited to inflammatory bowel disease (including Crohn's disease and ulcerative colitis), rheumatoid arthritis, systemic sclerosis (scleroderma), Systemic Lupus Erythematosus, or autoimmune vasculitis (e.g., Wegener's Granulomatosis). Alopecia, vitiligo, celiac disease controlled by diet, and chronic skin conditions not requiring systemic therapy/immunosuppressive treatment is permitted.
Uncontrolled intercurrent illness, including active infection requiring systemic therapy, uncontrolled hypertension (\> 150/90mm Hg despite optimal medical management), uncontrolled asthma, psychiatric illness/social situations, substance abuse, or other underlying medical conditions that would limit compliance with study requirements, obscure the interpretation of AEs, substantially increase the risk of developing AEs, or make the administration of study treatment hazardous.
Active human immunodeficiency virus (HIV) infection (Exception: patients with well-controlled HIV \[e.g., CD4 ≥ 350 cells/uL and undetectable viral load\] who have been on an effective \[drug, dosage, and schedule associated with reduction and control of the viral load\] antiretroviral therapy \[ART\] for ≥ 4 weeks are eligible). Patients with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections in the last 12 months are not eligible.
Active or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Patients with a history of HCV infection must have completed curative antiviral treatment and must have a viral load below the limit of quantification. A patient who is HCV antibody (Ab) positive but HCV RNA negative due to prior treatment or natural resolution is eligible.
History of solid organ transplantation.
Newly diagnosed, uncontrolled, and/or untreated cancer-related central nervous system disease. Patients with treated brain metastases that are radiographically or clinically stable for at least 28 days after therapy and have no evidence of cavitation or hemorrhage in the brain lesion(s) are eligible if they are asymptomatic and do not require corticosteroids (the patient must have discontinued steroids at least 14 days prior to Cycle 1 Day 1).
Major surgery, open biopsy, or significant traumatic injury within 28 days of Cycle 1 Day 1, or still recovering from prior surgery. Port placement and other local procedures are allowed if completed at least 48 hours prior to Cycle 1 Day 1.
Abnormal pulmonary function within the previous 6 months prior to Cycle 1 Day 1, including history of or active pneumonitis, interstitial lung disease requiring the use of steroids, idiopathic pulmonary fibrosis, recurrent pleural effusion (including malignant origin), severe dyspnea at rest or requiring supplementary oxygen therapy. Subjects with pleural effusions that are small and not clinically significant (e.g. not causing shortness of breath) are eligible with Medical Monitor approval.
Patients who have experienced any infusion related reaction Grade 3 or higher from prior therapy per NCI CTCAE version 5.0
What this trial measures
- Phase 1a- Safety and tolerability of IMGS-001 by dose-limiting toxicities and adverse events21 days
Frequency and severity of dose limiting toxicities and adverse events
- Phase 1b- Recommended Phase 2 dose (RP2D) of IMGS-001 for specified tumor-specific cohorts as a pharmacologically optimal dose (POD)12 months
RP2D will be defined by pooling all available PK, PD, target engagement, efficacy, safety, and tolerability data from Part 1 and Part 2