MEM-288 Oncolytic Virus Alone and in Combination With Standard of Care Therapy in Advanced Solid Tumors

Part of paid clinical trials in Tampa, Florida.

Sponsor
Memgen, Inc.
Study ID
NCT05076760
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MEM-288 Intratumoral Injection — BIOLOGICAL
    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).
  • Nivolumab — BIOLOGICAL
    anti-PD1 monoclonal antibody
  • Docetaxel — DRUG
    75 mg/m2 intravenous administration every 3 weeks

Study Details

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.

Key Dates

Start date
Apr 21, 2022
Status verified
Jun 2026
Primary completion
Feb 28, 2027
Completion
Dec 31, 2031

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MEM-288 Intratumoral Injection (Complete)
    Part 1A MEM-288 monotherapy: Patients with accessible, subcutaneous, or superficial lymph node lesion ≥ 1 cm3 that is palpable will receive intratumoral injection of MEM-288 once every 3 week (planned 2 doses, maximum 6 doses) at one of three dose cohort levels. * Dose cohort level 1 (1 x 10\^10 viral particles) * Dose cohort level 2 (3.3 x 10\^10 viral particles) * Dose cohort level 3 (1 x 10\^11 viral particles)
  • Experimental: MEM-288 Intratumoral Injection plus anti-PD1 (Nivolumab) Intravenous Infusion (Complete)
    Part 1B MEM-288 plus nivolumab combination: Patients with accessible, subcutaneous, or superficial lymph node lesion ≥ 1 cm3 that is palpable will receive intratumoral injection of MEM-288 maximum total dose of 1x10\^11 viral particles once every 3 week (planned 2 doses, maximum 6 doses). MEM-288 may be injected in multiple lesions until the maximum injection dose (1x10\^11 viral particles) is reached (minimum dose per lesion of 1x10\^10 viral particles). Nivolumab 360 mg IV every 3 weeks.
  • Experimental: MEM-288 Intratumoral Injection plus Docetaxel Intravenous Infusion (Open)
    Part 1C MEM-288 plus docetaxel combination: Patients with advanced NSCLC will be randomized 1:1 to receive either an initial priming dose of MEM-288 (1x10\^11 viral particles) injected into an accessible lesion(s) alone (Day 1) followed by MEM-288 in combination with standard of care docetaxel every 3 weeks, with up to 6 doses MEM-288, 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 of MEM-288.

Primary Outcome Measure

Part 1A Monotherapy: Maximum Tolerated Dose (MTD) [ Time Frame: 21 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Luiziane Guerra-Guevara
[email protected]
813-745-7789
Andreas Saltos, MD (PRINCIPAL_INVESTIGATOR)
Duke Cancer InstituteDurhamNorth Carolina27710-

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