NCT05492682

START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer

A Study to Evaluate the Safety and Immune Activity of PeptiCRAd-1 in Combination With Pembrolizumab in Patients With Injectable Solid Tumors in Indications Known to Express NY-ESO-1 and MAGE-A3

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Valo Therapeutics Oy · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to explore the immunological mechanism of action of Peptide-coated Conditionally Replicating Adenovirus-1 (PeptiCRAd-1) plus Checkpoint inhibitor (CPI) therapy in multiple cancer types, as well as to obtain early information on the safety of this combination therapy.

Detailed description

This is a Phase I, open-label, non-randomized, first-in-human study. All patients will be pre-treated with a low dose of intravenous (i.v.) Cyclophosphamide (CPO) followed by monotherapy doses of PeptiCRAd-1. PeptiCRAd-1 will be administered by intratumoral (i.t.) injection (Cohort 1) and by i.t. and subcutaneous (s.c.) injection (Cohort 2) followed by combination therapy with PeptiCRAd-1 and i.v. CPI (pembrolizumab).

Conditions

• Melanoma (Skin)
• Triple-Negative Breast Cancer
• Non-Small Cell Lung Cancer
• Synovial Sarcoma
• Myxoid Liposarcoma
• Colorectal Cancer
• Osteosarcoma
• Sarcoma

Interventions

Type	Name	Description
DRUG	PeptiCRAd-1	All patients will receive PeptiCRAd-1.
DRUG	Cyclophosphamide	All patients will be pre-treated with one single dose of Cyclophosphamide.
DRUG	Pembrolizumab	All patients will receive 6 doses of Pembrolizumab within the study.

Timeline

• Start date: 2023-02-02
• Primary completion: 2026-10-30
• Completion: 2026-12-31
• First posted: 2022-08-08
• Last updated: 2025-09-05

Locations

3 sites across 1 country: Germany