MEM-288 Oncolytic Virus Alone and in Combination With Standard of Care Therapy in Advanced Solid Tumors
Phase I Study Evaluating MEM-288 Oncolytic Virus Alone and in Combination With Standard of Care Therapy in Advanced Solid Tumors
1 other identifier
interventional
40
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2022
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2021
CompletedFirst Posted
Study publicly available on registry
October 13, 2021
CompletedStudy Start
First participant enrolled
April 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2031
August 29, 2025
August 1, 2025
4.8 years
September 20, 2021
August 25, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Part 1A Monotherapy: Maximum Tolerated Dose (MTD)
MTD is defined as the highest dose with ≤ 17% dose limiting toxicity (DLT) rate.
21 days
Safety and Tolerability assessed by Adverse Events (AEs)
An adverse event (AE) is any untoward medical occurrence in a subject receiving study drug and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not related to use of the study drug.
4.5 months
Secondary Outcomes (4)
Overall Response Rate (ORR)
up to 39 weeks
Disease Control Rate (DCR)
up to 39 weeks
Progression Free Survival (PFS)
up to 5 years
Overall Survival (OS)
up to 5 years
Other Outcomes (1)
Exploratory Biomarker Analysis
4.5 months
Study Arms (3)
MEM-288 Intratumoral Injection (Complete)
EXPERIMENTALPart 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)
MEM-288 Intratumoral Injection plus anti-PD1 (Nivolumab) Intravenous Infusion (Complete)
EXPERIMENTALPart 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.
MEM-288 Intratumoral Injection plus Docetaxel Intravenous Infusion (Open)
EXPERIMENTALPart 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.
Interventions
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).
anti-PD1 monoclonal antibody
75 mg/m2 intravenous administration every 3 weeks
Eligibility Criteria
You may qualify 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.
- 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 subjects with specific histologies must have progressed have been included. Subjects will have been treated with at least one or more than one line of therapy prior to enrollment in the study.
- 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 1B MEM-288 plus nivolumab combination
- 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 docetaxel combination must have either:
- first progression with anti-PD-1 or PD-L1 checkpoint inhibitor therapy with or without concurrent chemotherapy, or
- +41 more criteria
You may not qualify if:
- 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 interpretation of study results.
- 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. Video-assisted thoracic surgery (VATS) and mediastinoscopy are exceptions and patients can receive study treatment ≥1 week after these procedures.
- 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 at least 2 years prior to study entry AND no additional therapy is required or anticipated to be required during the study period.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memgen, Inc.lead
- H. Lee Moffitt Cancer Center and Research Institutecollaborator
- Duke Cancer Institutecollaborator
Study Sites (2)
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Duke Cancer Institute
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neal Ready, MD, PhD
Duke Cancer Institute
- PRINCIPAL INVESTIGATOR
Andreas Saltos, MD
H. Lee Moffitt Cancer Center and Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2021
First Posted
October 13, 2021
Study Start
April 21, 2022
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
December 1, 2031
Last Updated
August 29, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- Immediately following publication. No end date.
- Access Criteria
- Anyone who wishes to access the data.
Memgen, Inc. is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission.