About the Phase 1 Trial of Eftilagimod Alpha in Advanced Stage Solid Tumors
Trial Name: An Explorative Phase I Study to Evaluate Feasibility and Safety of Intra-tumoral, Intra-peritoneal, and Subcutaneous Injection of IMP321 (Eftilagimod Alpha; LAG-3Ig Fusion Protein) Alone or in Combination for Advanced Stage Solid Tumors
ClinicalTrials.gov Identifier: NCT03252938
Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Recruitment Contact: Salah-Eddin Al-Batran, MD, 4969 7601 ext 4420, albatran@ikf-khnw.de and Regina Eickhoff, PhD, 4969 7601 ext 4165, eickhoff.regina@ikf-khnw.de
Completion Date: June 30, 2024
The phase 1 INSIGHT-005 clinical trial (NCT03252938) will evaluate the use of eftilagimod alpha (IMP321) for patients with urothelial cancer (mUC).1
The launch of the study builds on promising clinical data which were previously reported in the INSIGHT-004 study of patients with multiple solid tumors who were given the combination of eftilagimod alpha and avelumab (Bavencio).
“We are very pleased to be deepening our collaboration with Merck KGaA, Darmstadt, Germany and Pfizer through this new study in patients with urothelial cancer, the sixth most common cancer in the United States, who are in need of treatment options,” said Marc Voigt, chief executive officer of Immutep Limited, in the press release. “INSIGHT-005 builds on the encouraging clinical efficacy and safety previously reported from the combination of [eftilagimod alpha] and avelumab in various solid cancers, including deep and durable responses in patients with low or no PD-L1 expression and in indications that typically do not respond to immune checkpoint therapy.”
The open-label, explorative, investigator-initiated, phase 1 INSIGHT-005 trial is assessing the safety and efficacy of eftilagimod alpha in combination with avelumab as a treatment option for patients with mUC. Approximately 30 patients will be enrolled in this portion of the study.2
The trial will take place in Germany as a part of the investigator-initiated INSIGHT platform which is investigating different combinations of eftilagimod alpha with other agents for patients with metastatic solid tumors.
Enrollment in INSIGHT-005 is open to male and female patients aged 18 years and older with an ECOG performance status of 0 or 1, adequate hematological, hepatic, renal, and coagulation functions, expected survival greater than 3 months, and resolution of toxicity associated with prior or current therapy to grade 1-2, excluding alopecia and transaminases in case of liver metastases.
The primary end point of the study is feasibility rate with the secondary end points of incidence and severity of adverse events, objective response rate, progression-free survival, overall survival, and immune response in whole blood and tumor tissue.
