A Phase I, open-label, non-randomized study to evaluate the safety and immune activity of PeptiCRAd-1, a conditionally replicating adenovirus coated with tumor-specific peptides, in combination with the immune checkpoint inhibitor pembrolizumab in patients with injectable solid tumors known to express NY-ESO-1 and MAGE-A3.
Principal Investigator
Dott.ssa Vanesa Gregorc
Contact Information for Access
Phase
FASE I (FIH)
Status
ATTIVO
Objective of the study
The main objective of this study is to gather information on the safety and side effects of PeptiCRAd-1 when administered to patients either alone or in combination with pembrolizumab.
The study will also examine how the immune system responds to PeptiCRAd-1 and, consequently, how the course of the disease might change during treatment.
Melanoma
Triple-Negative Breast Cancer
Non-Squamous Lung Cancer
Osteosarcoma
Synovial Sarcoma
Round-Cell Myxoid Liposarcoma
EUCT number: 2024-517580-23-00
Sponsor: Valo Therapeutics Oy
Pathologies
Breast Cancer , Gastrointestinal tumor (GI tumor) , Melanoma , Multiple oncological conditions , Sarcomi tumori rari e GIST
Medication
Oncolytic virus (PeptiCRAd-1)
Pembrolizumab
Cyclophosphamide
Who is eligible to participate in the study?
Patients who are 18 years of age or older and who meet the study’s eligibility criteria may participate in this study.
Patients diagnosed with:
- Melanoma or
- Triple-negative breast cancer or
- Non-squamous lung cancer or
- Osteosarcoma or
- Synovial sarcoma or
- Round-cell myxoid liposarcoma who have exhausted standard treatments for their condition.
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