Phase I Study Evaluating MEM-288 Oncolytic Virus Alone and in Combination With Standard of Care Therapy in Advanced Solid Tumors
Memgen, Inc.
Summary
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.
Description
MEM-288 is a conditionally replicative oncolytic adenovirus vector encoding transgenes for human interferon beta (IFNβ) and a recombinant chimeric form of CD40-ligand (MEM40). MEM-288 was developed as an immunotherapy for cancer and was engineered to selectively replicate in cancer cells leading to cancer cell lysis but not cytotoxicity towards normal cells. Simultaneously, MEM-288 is designed to stimulate an anti-tumor immune response through expression of its encoded immune agonist transgenes. MEM-288 is designed to provide both antitumor activity as a standalone monotherapy and in combinati…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Ability to understand and provide informed consent. 2. Willingness and ability to comply with scheduled study visits and procedures. 3. Adult men or women age ≥ 18 years. 4. ECOG performance status of 0 or 1. 5. Part 1A monotherapy: Advanced/metastatic NSCLC, cSCC, Merkel cell, melanoma, TNBC, pancreatic cancer, or head and neck cancer. 6. Parts 1B and 1C combination: Advanced/metastatic NSCLC which has progressed following front-line anti-PD-1/PD-L1 with or without concurrent chemotherapy. 7. Per each tumor type shown below, the specific initial standard of care therap…
Interventions
- BiologicalMEM-288 Intratumoral Injection
Intratumoral injection of MEM-288, conditionally replicative oncolytic adenovirus vector encoding transgenes for human interferon beta (IFNβ) and a recombinant chimeric form of CD40-ligand (MEM40).
- BiologicalNivolumab
anti-PD1 monoclonal antibody
- DrugDocetaxel
75 mg/m2 intravenous administration every 3 weeks
Locations (2)
- Moffitt Cancer CenterTampa, Florida
- Duke Cancer InstituteDurham, North Carolina