OncoMatch/Clinical Trials/NCT05076760
MEM-288 Oncolytic Virus Alone and in Combination With Standard of Care Therapy in Advanced Solid Tumors
Is NCT05076760 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including MEM-288 Intratumoral and Nivolumab for solid tumor.
Treatment: MEM-288 Intratumoral · Nivolumab · Docetaxel — 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. The dose escalation phase (Part 1A - advanced solid tumors) has completed and is closed to enrollment. This phase evaluated multiple doses of MEM-288 dosed via intratumoral injection once every 3 weeks to assess safety, tolerability, preliminary efficacy, and to determine the MTD. The dose expansion phase has multiple parts for advanced NSCLC. Part 1B has completed after evaluation of MEM-288 dosed via intratumoral injection in combination with standard of care nivolumab dosed via intravenous injection. In a separate dose expansion arm (Part 1C) that is open for enrollment, patients with advanced NSCLC will be randomized to receive either an initial priming dose of MEM-288 injected into an accessible lesion (s) alone (Day 1) followed by MEM-288 in combination with standard of care docetaxel every 3 weeks up to 6 doses or MEM-288 injected into an accessible lesion(s) in combination with standard of care docetaxel therapy Day 1 and every 3 weeks up to 6 doses. The study rationale is that the oncolytic effect of MEM-288 combined with the presence of CD40L and type 1 IFN in injected tumors will provide a strong signal for DC-mediated T cell activation leading to generation of systemic anti-tumor T cell responses with broad specificity akin to what is observed in the abscopal effect.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Small Cell Lung Cancer
Melanoma
Pancreatic Cancer
Triple-Negative Breast Cancer
Breast Carcinoma
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Allowed: EGFR activating mutation
Patients with activating EGFR mutation ... must have been previously treated with an applicable tyrosine kinase inhibitor
Allowed: ALK rearrangement
Patients with ... ALK rearrangement ... must have been previously treated with an applicable tyrosine kinase inhibitor
Allowed: ROS1 rearrangement
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.
Allowed: BRAF V600E
Subjects must have received a BRAF inhibitor as monotherapy or in combination with other targeted agents for BRAF V600E mutant melanoma.
Allowed: RET rearrangement
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.
Allowed: MET mutation
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.
Allowed: KRAS mutation
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.
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — disease-specific (see tumor type)
Must have progressed on standard therapy, including platinum-based chemotherapy and checkpoint inhibitor therapy (combined or sequential).
Must have received: checkpoint inhibitor — disease-specific (see tumor type)
Must have progressed on standard therapy, including platinum-based chemotherapy and checkpoint inhibitor therapy (combined or sequential).
Must have received: EGFR tyrosine kinase inhibitor — NSCLC with EGFR mutation
Patients with activating EGFR mutation ... must have been previously treated with an applicable tyrosine kinase inhibitor.
Must have received: ALK inhibitor — NSCLC with ALK rearrangement
Patients with ... ALK rearrangement ... must have been previously treated with an applicable tyrosine kinase inhibitor.
Must have received: BRAF inhibitor — BRAF V600E mutant melanoma
Subjects must have received a BRAF inhibitor as monotherapy or in combination with other targeted agents for BRAF V600E mutant melanoma.
Must have received: anti-PD-1 therapy — all except pancreatic cancer
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.
Must have received: gemcitabine (gemcitabine) — pancreatic cancer
Progression after systemic chemotherapy which included either gemcitabine or Fluorouracil (5-FU)-based regimen (including capecitabine).
Must have received: antimetabolite (fluorouracil, capecitabine) — pancreatic cancer
Progression after systemic chemotherapy which included either gemcitabine or Fluorouracil (5-FU)-based regimen (including capecitabine).
Must have received: taxane — TNBC
Prior treatment (for advanced, metastatic or (neo)adjuvant) must have included a taxane and/or anthracycline-based therapy.
Must have received: anthracycline — TNBC
Prior treatment (for advanced, metastatic or (neo)adjuvant) must have included a taxane and/or anthracycline-based therapy.
Must have received: platinum-based chemotherapy — head and neck cancer
Subjects must have received a platinum containing chemotherapy regimen for treatment of primary tumor in locally advanced, or metastatic settings
Must have received: anti-PD-1 therapy — head and neck cancer
Subjects must have received an anti-PD-1/ PD-L1 as monotherapy or in combination with chemotherapy.
Cannot have received: anti-tumor vaccine
Exception: FDA approved and NCCN recommended systemic therapies allowed
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).
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1.5 x 10^9/L; Hemoglobin ≥90 g/L (or ≥9 g/dL); Platelets ≥100 x 10^9/L
Kidney function
Calculated creatinine clearance of >50 mL/min using Cockcroft Gault equation
Liver function
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
Adequate organ and marrow function as defined below: 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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffitt Cancer Center · Tampa, Florida
- Duke Cancer Institute · Durham, North Carolina
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