NCT03252938

Feasibility and Safety of IMP321 (Eftilagimod Alpha) for Advanced Stage Solid Tumors

An Explorative, Open-labeled, Phase I Study to Evaluate the Feasibility and the Safety of IMP321 in Combination With Immunotherapeutic/Targeted/Chemotherapeutic Agents or Via New Routes of Application in Advanced Stage Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial aims to investigate a potential enhancement of IMP321 immune-activating effects by new routes of administration: direct injection of IMP321 into the tumor tissue; intra-peritoneal therapy; combination of chemotherapy and/or immunotherapy/targeted therapy with active immunotherapy

Detailed description

Up to now, IMP321 is solely administered by sub-cutaneous injection (e.g. on the anterior face of the thigh). In this study, we investigate whether a direct injection of IMP321 into the tumor tissue will be a useful option to improve anti-tumor immune response by placing the immune-therapeutic agent in direct vicinity of immune infiltrates in the tumor bed. This bypasses processes necessary for drug delivery to cells of solid tumors following systemic administration, like transport within vessels, transport across vasculature walls into surrounding tissues, and - in cases of peritoneal metastases - transport through the interstitial space within a tumor. For the latter case, we will also explore if an intra-peritoneal therapy represents a feasible alternative by means of delivering high drug concentrations directly to tumors located in the peritoneal cavity. Furthermore, we will explore the possibility to extend the positive results obtained by subcutaneous injections of IMP321 in metastatic renal cell and breast carcinomas to further solid tumor entities e.g. non-small cell lung cancer (NSCLC) and urothelial carcinoma. In this part of the study, patients will be treated with the standard-of-care (SOC) chemotherapy and/or immunotherapy/targeted therapy for their tumor entity along with subcutaneous injections of IMP321.

Conditions

• Solid Tumors
• Peritoneal Carcinomatosis
• NSCLC Adenocarcinoma
• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	IMP321	LAG-3Ig fusion protein, highly potent activator of antigen presenting cells
DRUG	Avelumab	Avelumab i.v.

Timeline

• Start date: 2017-08-15
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2017-08-17
• Last updated: 2026-02-19

Locations

12 sites across 1 country: Germany