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New treatment option for Solid Tumor
Official title Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06014502
What this study is testing
What is IMGS-001?
IMGS-001 is an investigational medicine, being studied as a potential treatment for solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Part 1 Dose-escalation: Patients must have histologically confirmed locally advanced, or metastatic solid tumors who have progressed after receiving...
- Part 2 Dose-expansion: Patients must have histologically confirmed locally advanced, or metastatic cancer in one of the following pre-specified tumor...
- Nasopharyngeal: non-keratinizing; ≤ 2 prior lines of therapy in relapse setting; patients should have received prior chemotherapy and/or immune...
- 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...
You likely can't join if
- 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...
- 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...
- Prior anti-PD-1 or anti-PD-L1-related Grade 3 or Grade 4 toxicity resulting in treatment discontinuation of the drug.
See the full eligibility criteria
Who can join
- 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...
- 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:
- 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...
- NSCLC (non-mutated, squamous/non-squamous): ≤ 2 prior lines of therapy in relapse setting; patients could have received prior chemotherapy, immune checkpoint blockade, or targeted therapy in earlier lines of therapy as...
- Head and neck squamous cell carcinoma (HPV+): ≤ 2 prior lines of therapy in relapse setting; patients could have received prior chemotherapy, immune checkpoint blockade, or cetuximab as appropriate per SOC; confirmed...
- Patients eligible to enroll in cohorts with prior immune checkpoint therapy must meet the following criteria:
- Received at least 2 doses of an approved or investigational anti PD-1 or anti-PD-L1 inhibitor.
- Last dose of therapy must have been ≥ 28 days prior to Cycle 1 Day 1.
- Eligible patients include those patients treated with anti PD-1/anti PD-L1 drugs who have progressed following response to prior therapy, and those that have failed to demonstrate any response to prior therapy.
- 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. people 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:
- Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L.
- Platelet count of ≥ 100.0×10\^9/L.
- Hemoglobin of ≥ 9.0 g/dL.
- Creatinine clearance ≥ 30 mL/min.
- Liver function test: AST (SGOT) and ALT (SGPT) ≤ 2.5 times the institutional ULN.
- Total bilirubin: ≤ 1.5 x ULN.
What rules you out
- 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...
- 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. people with a history of carcinoma in situ, basal cell carcinoma and other malignancies with low risk of...
- 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...
- Uncontrolled intercurrent illness, including active infection requiring systemic therapy, uncontrolled hypertension (\> 150/90mm Hg despite optimal medical management), uncontrolled asthma, psychiatric illness/social...
- 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...
- 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...
- 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...
- 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...
- 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...
- Patients who have experienced any infusion related reaction Grade 3 or higher from prior therapy per NCI CTCAE version 5.0
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Orange, California, United States
- Santa Monica, California, United States
- Tampa, Florida, United States
- Edgewood, Kentucky, United States
- New Orleans, Louisiana, United States
- St Louis, Missouri, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- Irving, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; Orange, California, United States; Santa Monica, California, United States; Tampa, Florida, United States; Edgewood, Kentucky, United States; New Orleans, Louisiana, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.