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

Recruiting now · Phase 1

Conditions studied: Solid Tumor, Advanced Cancer, Metastatic Cancer, Non Small Cell Lung Cancer, Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma, Melanoma, Pancreatic Cancer, Triple Negative Breast Cancer, Head and Neck Cancer

In brief

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 facts

Study ID

NCT05076760

Run by

Memgen, Inc.

People needed

40

Starts

2022-04-21

Expected to finish

2031-12-01

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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
• Subjects must have received a BRAF inhibitor as monotherapy or in combination with other targeted agents for BRAF V600E mutant melanoma.
• Subjects 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).

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.
• 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 subjects 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.

Where it is running

• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Duke Cancer Institute — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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