Ignite Creation Date:
2024-05-06 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05076760
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2021-09-20
Brief Title:
MEM-288 Oncolytic Virus Alone and in Combination With Nivolumab in Solid Tumors Including Non-Small Cell Lung Cancer
Sponsor:
Memgen Inc
Organization:
Memgen Inc
Study Overview
Official Title:
Phase I Study of MEM-288 Oncolytic Virus Alone and in Combination With Nivolumab in Solid Tumors Including Non-Small Cell Lung Cancer NSCLC
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial is designed in two parts First as an open-label dose escalation trial of MEM-288 monotherapy in which investigators aim to find the maximum tolerated dose MTD and recommended phase II dose RP2D Subjects with selected solid tumors including non-small cell lung cancer NSCLC who have a tumor lesion which is accessible for injection will undergo intratumoral injection of MEM-288 Following completion of the monotherapy study portion of the study an expansion arm is designed to test MEM-288 with concurrent anti-PD-1 nivolumab therapy for patients with first relapsed or refractory advancedmetastatic NSCLC following front-line anti-PD-1PD-L1 with or without concurrent chemotherapy The study rationale is that the oncolytic effect of MEM-288 combined with the presence of CD40L and type 1 interferon IFN in injected tumors will provide a strong signal for dendritic cell 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 Further study rationale is the anti-tumor effect of MEM-288 will be enhanced by nivolumab by reversing T cell exhaustion
Detailed Description:
MEM-288 is a conditionally replicative oncolytic adenovirus vector encoding transgenes for human interferon beta IFNβ and a recombinant chimeric form of CD40-ligand MEM40 MEM-288 was developed as an immunotherapy for cancer and was engineered to selectively replicate in cancer cells leading to cancer cell lysis but not cytotoxicity towards normal cells Simultaneously MEM-288 is designed to stimulate an anti-tumor immune response through expression of its encoded immune agonist transgenes MEM-288 is designed to provide both antitumor activity as a standalone monotherapy and in combination with immune checkpoint inhibitors to enhance the efficacy of immune checkpoint inhibition in solid tumors
This phase I trial will be conducted in two parts The first part is an open-label dose escalation trial of MEM-288 monotherapy in which investigators aim to find the MTD and recommended phase II dose for the planned combination of MEM-288 with an immune checkpoint inhibitor Patients 18 years old eligible for study enrollment include those with either advancedmetastatic NSCLC cutaneous squamous-cell carcinoma cSCC Merkel cell melanoma triple negative breast cancer TNBC pancreatic cancer or head and neck cancer who progressed following previous anti-PD-1PD-L1 therapy with a tumor lesion which is accessible for injection
The primary study objective of the monotherapy dose escalation portion of the study is to determine the safety tolerability and maximum tolerated dose MTD of intratumoral administration of MEM-288 as a single agent Secondary objectives will assess efficacy overall response rate as well as disease control rate progression free survival duration of response and anti-tumor immune responses
The second part of the phase 1 trial is an expansion arm designed to test MEM-288 with concurrent anti-PD-1 nivolumab therapy for patients with first relapsed or refractory advancedmetastatic NSCLC following front-line anti-PD-1PD-L1 with or without concurrent chemotherapy
The primary study objective of the combination portion of the study is to determine the overall response rate of the combination of MEM-288 plus nivolumab in patients with advanced recurrentmetastatic NSCLC Secondary objectives will assess the safety and tolerability of MEM-288 plus nivolumab as well as disease control rate progression free survival duration of response and anti-tumor immune responses
MEM-288 will be administered via intratumoral injection once every 3 weeks planned 2 doses maximum 6 doses at an assigned dose cohort level from 1x1010 to 1x1011 viral particles for the monotherapy portion of the study
For the combination portion of the study MEM-288 will be administered via intratumoral injection once every 3 weeks planned 2 doses maximum 6 doses at an assigned dose total dose of 1x1011 viral particles MEM-288 may be injected in multiple lesions until the maximum injection dose 1x1011 viral particles is reached Nivolumab will be administered at a dose of 360 mg via intravenous infusion once every 3 weeks with optional maintenance nivolumab therapy every 3 weeks for up to 2 years
This phase I trial will be conducted in two parts The first part is an open-label dose escalation trial of MEM-288 monotherapy in which investigators aim to find the MTD and recommended phase II dose for the planned combination of MEM-288 with an immune checkpoint inhibitor Patients 18 years old eligible for study enrollment include those with either advancedmetastatic NSCLC cutaneous squamous-cell carcinoma cSCC Merkel cell melanoma triple negative breast cancer TNBC pancreatic cancer or head and neck cancer who progressed following previous anti-PD-1PD-L1 therapy with a tumor lesion which is accessible for injection
The primary study objective of the monotherapy dose escalation portion of the study is to determine the safety tolerability and maximum tolerated dose MTD of intratumoral administration of MEM-288 as a single agent Secondary objectives will assess efficacy overall response rate as well as disease control rate progression free survival duration of response and anti-tumor immune responses
The second part of the phase 1 trial is an expansion arm designed to test MEM-288 with concurrent anti-PD-1 nivolumab therapy for patients with first relapsed or refractory advancedmetastatic NSCLC following front-line anti-PD-1PD-L1 with or without concurrent chemotherapy
The primary study objective of the combination portion of the study is to determine the overall response rate of the combination of MEM-288 plus nivolumab in patients with advanced recurrentmetastatic NSCLC Secondary objectives will assess the safety and tolerability of MEM-288 plus nivolumab as well as disease control rate progression free survival duration of response and anti-tumor immune responses
MEM-288 will be administered via intratumoral injection once every 3 weeks planned 2 doses maximum 6 doses at an assigned dose cohort level from 1x1010 to 1x1011 viral particles for the monotherapy portion of the study
For the combination portion of the study MEM-288 will be administered via intratumoral injection once every 3 weeks planned 2 doses maximum 6 doses at an assigned dose total dose of 1x1011 viral particles MEM-288 may be injected in multiple lesions until the maximum injection dose 1x1011 viral particles is reached Nivolumab will be administered at a dose of 360 mg via intravenous infusion once every 3 weeks with optional maintenance nivolumab therapy every 3 weeks for up to 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None