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New treatment option for Solid Tumor
Official title MEM-288 Oncolytic Virus Alone and in Combination With Standard of Care Therapy in Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05076760
What this study is testing
What is MEM-288 Intratumoral Injection?
MEM-288 Intratumoral Injection is an investigational medicine, given as an infusion into a vein, 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
- This is a multipart, open-label, multi-center dose escalation, dose expansion phase I clinical trial designed to evaluate the safety, tolerability, maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), and preliminary efficacy of MEM-288 in patients with advanced solid tumors. Eligible subjects must have a tumor lesion(s) which is accessible for injection.
- Phase 1: an early, usually small safety study
- Time commitment: about 2 years
- 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
- Ability to understand and provide informed consent.
- Willingness and ability to comply with scheduled study visits and procedures.
- Adult men or women age ≥ 18 years.
- ECOG performance status of 0 or 1.
- Part 1A monotherapy: Advanced/metastatic NSCLC, cSCC, Merkel cell, melanoma, TNBC, pancreatic cancer, or head and neck cancer.
You likely can't join if
- Pregnant or breast feeding.
- Serious uncontrolled medical disorder, psychiatric condition or laboratory abnormalities that, in the opinion of the investigator, may increase the...
- Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic), or significant traumatic injury, within 4 weeks prior to starting study...
- History of clinically significant noninfectious interstitial pneumonitis (i.e., limiting activities of daily living or requiring therapeutic...
- Residual toxicity from prior anticancer therapy of grade 3 or greater (CTCAE v5.0), with the exception of alopecia.
- Concurrent use of other anticancer approved or investigational agents.
See the full eligibility criteria
Who can join
- Ability to understand and provide informed consent.
- Willingness and ability to comply with scheduled study visits and procedures.
- Adult men or women age ≥ 18 years.
- ECOG performance status of 0 or 1.
- Part 1A monotherapy: Advanced/metastatic NSCLC, cSCC, Merkel cell, melanoma, TNBC, pancreatic cancer, or head and neck cancer.
- Parts 1B and 1C combination: Advanced/metastatic NSCLC which has progressed following front-line anti-PD-1/PD-L1 with or without concurrent chemotherapy.
- Per each tumor type shown below, the specific initial standard of care therapies after which the people with specific histologies must have progressed have been included. people will have been treated with at least one...
- Non-small cell lung cancer (NSCLC) Part 1A monotherapy
- Must have progressed on standard therapy, including platinum-based chemotherapy and checkpoint inhibitor therapy (combined or sequential).
- Patients with tumors that have known actionable molecular alteration such in EGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS must have progressed on standard directed molecular therapy, and platinum-based chemotherapy. Part...
- Must have first progression more than (\>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or PD-L1 checkpoint inhibitor therapy with or without concurrent chemotherapy Part 1C MEM-288 plus...
- first progression with anti-PD-1 or PD-L1 checkpoint inhibitor therapy with or without concurrent chemotherapy, or
- progressed following initial first line anti-PD-1 or PD-L1 monotherapy followed by 2nd line platinum chemotherapy (with or without continuation of their first line anti-PD-1 or PD-L1 therapy).
- Cutaneous squamous-cell carcinoma (cSCC)
- Must have progressed on standard therapy, including platinum-based chemotherapy and/or checkpoint inhibitor therapy.
- Merkel cell Carcinoma
- Must have progressed on standard checkpoint inhibitor therapy.
- Melanoma
- people must have received a BRAF inhibitor as monotherapy or in combination with other targeted agents for BRAF V600E mutant melanoma.
- people must have received an anti-PD-1/ PD-L1inhibitor as monotherapy or combination with anti-CTLA-4 inhibitor or other therapies.
- Pancreatic cancer
- Progression after systemic chemotherapy which included either gemcitabine or Fluorouracil (5-FU)-based regimen (including capecitabine).
- Triple negative breast cancer (TNBC)
- Prior treatment (for advanced, metastatic or (neo)adjuvant) must have included a taxane and/or anthracycline-based therapy.
- Head and Neck Cancer
- Prior treatment requirement in the metastatic or unresectable locally advanced setting include:
- people must have received a platinum containing chemotherapy regimen for treatment of primary tumor in locally advanced, or metastatic settings
- people must have received an anti-PD-1/ PD-L1 as monotherapy or in combination with chemotherapy.
- Progressed following therapy with at least one PD-1 or PD-L1 checkpoint inhibitor (regardless of PD-L1 expression status), except for patients with pancreatic cancer. a) Prior progression on a PD-1 or PD-L1 checkpoint...
- Patients with activating EGFR mutation or ALK rearrangement which is expected to be responsive to available tyrosine kinase inhibitor therapy, must have been previously treated with an applicable tyrosine kinase...
- Tumor lesion which is deemed feasible for biopsy and injection under CT or ultrasound guidance (based on size, location, and visibility) by an treatment radiologist, and patient willing and able to provide tissue from...
- Measurable disease, as defined per RECIST version 1.1.
- Prior history of brain metastases are eligible, provided:
- Brain metastases have been treated
- Asymptomatic from the brain metastases
- Corticosteroids prescribed for the management of brain metastases have been discontinued at least 7 days before registration to study
- Brain metastases are stable on pre-registration imaging
- No evidence of leptomeningeal disease
- Life expectancy \> 3 months.
- Adequate organ and marrow function as defined below:
- Absolute neutrophil count (ANC) ≥1.5 x 10\^9/L
- Hemoglobin ≥90 g/L (or ≥9 g/dL)
- Platelets ≥100 x 10\^9/L
- Calculated creatinine clearance of \>50 mL/min using Cockcroft Gault equation
- Total bilirubin ≤ 1.5 x institutional upper limit of normal
- AST (SGOT) and ALT (SGPT) ≤2.5 x institutional upper limit of normal
- If Alkaline Phosphatase ≥ 2.5 x institutional upper limit of normal, then AST and ALT must be ≤ 1.5 x institutional upper limit of normal
- Patients of childbearing age must not be pregnant and must use established contraceptive strategies:
- Female people of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as...
- Female people of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last...
- Male people should agree to use an adequate method of barrier contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
What rules you out
- Pregnant or breast feeding.
- Serious uncontrolled medical disorder, psychiatric condition or laboratory abnormalities that, in the opinion of the investigator, may increase the risk associated with study participation or may interfere with the...
- Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic), or significant traumatic injury, within 4 weeks prior to starting study treatment or has not recovered from side effects of such procedure...
- History of clinically significant noninfectious interstitial pneumonitis (i.e., limiting activities of daily living or requiring therapeutic intervention), including clinically significant radiation pneumonitis.
- Residual toxicity from prior anticancer therapy of grade 3 or greater (CTCAE v5.0), with the exception of alopecia.
- Concurrent use of other anticancer approved or investigational agents.
- Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months), such as:
- unstable angina within 6 months prior to screening
- myocardial infarction within 6 months prior to screening
- history of documented congestive heart failure (New York Heart Association functional classification III-IV)
- cardiac arrhythmias not controlled with medication
- Active autoimmune disease requiring disease modifying therapy (except vitiligo, Grave's, or psoriasis not requiring systemic treatment).
- Any form of active primary or secondary immunodeficiency.
- Receiving ≥10 mg daily prednisone (or equivalent).
- Prior malignancy (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, cervical/dysplasia endometrial, melanoma, or breast) are excluded unless a complete remission was achieved...
- Active systemic infections requiring intravenous antibiotics.
- Prior therapy with anti-tumor vaccines or other immune-stimulatory antitumor agents (other than FDA approved and National Comprehensive Cancer Network [NCCN] recommended systemic therapies).
- Prisoners or people who are involuntarily incarcerated, or who are compulsorily detained for treatment of either a psychiatric or physical illness.
- Any unresolved grade 2 irAE (except adequately treated endocrine irAE).
- Any toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy.
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
- Durham, North Carolina, 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 study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Tampa, Florida, United States; Durham, North Carolina, United States. 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.