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

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.

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

Interventions

BIOLOGICAL

MEM-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).

BIOLOGICAL

Nivolumab

anti-PD1 monoclonal antibody

DRUG

Docetaxel

75 mg/m2 intravenous administration every 3 weeks

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute

  collaborator OTHER

• Duke Cancer Institute

  collaborator OTHER

• Memgen, Inc.

  lead INDUSTRY

Principal Investigators

• Neal Ready, MD, PhD · Duke Cancer Institute

• Andreas Saltos, MD · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-21

Primary Completion

2027-02-28

Completion

2031-12-31

FDA Drug

Yes

Countries

• United States

Study Locations