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MEM-288 for Advanced Solid Tumors

This study is testing MEM-288, a special virus designed to fight cancer, either by itself or with standard treatments like Nivolumab (an immunotherapy) or Docetaxel (chemotherapy). MEM-288 works by infecting and killing cancer cells while also boosting your body's immune response against the tumor. Researchers want to find the safest and most effective dose of MEM-288. This trial is for adults with advanced solid tumors, including certain types of lung, skin, and other cancers, who have a tumor that can be injected. The first part of the study (monotherapy) has finished enrolling participants. The study is now focusing on different parts for advanced non-small cell lung cancer.

Study design
This is an open-label, multi-center Phase 1 study with multiple parts, aiming to enroll 40 participants. It is designed to find the best dose and check the safety and early effectiveness of MEM-288.
What's involved
Participants will receive MEM-288 injections into their tumor every 3 weeks. They will also have scheduled study visits and procedures.
Compensation
Not stated in the trial record.
Follow-up
Safety and side effects will be checked for about 4.5 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05076760

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Memgen, Inc.
~40 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:MEM-288 Intratumoral InjectionNivolumabDocetaxel

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1A Monotherapy: Maximum Tolerated Dose (MTD)
Measured over 21 days
+1 more outcome measured

Conditions

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

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Where it's being run

2 sites across 2 states
Florida1
North Carolina1

Study leadership

  • Neal Ready, MD, PhD · PRINCIPAL_INVESTIGATOR · Duke Cancer Institute
  • Andreas Saltos, MD · PRINCIPAL_INVESTIGATOR · H. Lee Moffitt Cancer Center and Research Institute

Who to contact

Chairman, PhD
[email protected]
858-888-0271
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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
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). 2. Cutaneous squamous-cell carcinoma (cSCC)
Must have progressed on standard therapy, including platinum-based chemotherapy and/or checkpoint inhibitor therapy. 3. Merkel cell Carcinoma
Must have progressed on standard checkpoint inhibitor therapy. 4. 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. 5. Pancreatic cancer
Progression after systemic chemotherapy which included either gemcitabine or Fluorouracil (5-FU)-based regimen (including capecitabine). 6. Triple negative breast cancer (TNBC)
Prior treatment (for advanced, metastatic or (neo)adjuvant) must have included a taxane and/or anthracycline-based therapy. 7. Head and Neck Cancer
Prior treatment requirement in the metastatic or unresectable locally advanced setting include:
Subjects must have received a platinum containing chemotherapy regimen for treatment of primary tumor in locally advanced, or metastatic settings
Subjects must have received an anti-PD-1/ PD-L1 as monotherapy or in combination with chemotherapy. 8. 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.

What this trial measures

  • Part 1A Monotherapy: Maximum Tolerated Dose (MTD)21 days

    MTD is defined as the highest dose with ≤ 17% dose limiting toxicity (DLT) rate.

  • Safety and Tolerability assessed by Adverse Events (AEs)4.5 months

    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.