NCT04260529

CyPep-1 Injections in Cancer Inducing Lymphocyte Infiltrate Accumulations

A First-in-human, Open-label Dose Escalation Followed by Dose Expansion Phase I/IIa Trial to Evaluate the Safety, Preliminary Efficacy and Pharmacokinetics of Intratumoral CyPep-1 Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Cancers.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Cytovation AS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase I/IIa trial is designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of CyPep-1 when administered directly into malignant tumors in monotherapy and in combination with anti programmed cell death protein 1(anti-PD-1) antibody pembrolizumab. Additionally, the trial will monitor anti-tumor effects on both injected lesions and distant non-injected deposits.

Detailed description

Treatment with immune modulating agents may result in long lasting anti-tumor responses in patients with cancer. However, only a subset of patients obtains durable remission. Treatment strategies that aim at recruiting tumor antagonizing cellular components of the immune system holds great promise. CyPep-1 is a chemically synthesized peptide with oncolytic properties. It selectively targets cancer cells based on their altered molecular composition, and removes the surrounding cell membrane. This releases tumor neoantigens to the microenvironment and potentially induces an anti-tumour immune response. Preclinical studies showing that CyPep-1 can synergize with anti-PD-1 antibody treatment in terms of decreased tumor volumes and prolonged survival highlight the possible clinical utility of CyPep-1 in the combination setting with Immune checkpoint inhibitors (ICIs). This is a phase I/IIa, open label trial, with a dose escalation phase to evaluate the safety and tolerability of CyPep-1 as monotherapy and in combination with pembrolizumab, to identify the recommended phase 2 dose, followed by a dose expansion phase in subjects with advanced solid tumors. The trial consists of two phases and multiple arms. Secondary objectives are preliminary anti-tumor efficacy and to assess the pharmacokinetics (PK) of CyPep-1 as monotherapy and in combination with pembrolizumab. As part of the exploratory analysis, it is planned to determine local and systemic immunological effects after CyPep-1 administration, alone and in combination with pembrolizumab.

Conditions

• Advanced Solid Tumor Malignancy

Interventions

Type	Name	Description
DRUG	CyPep-1	Intratumoral injection
DRUG	Pembrolizumab 25 MG/ML [KEYTRUDA®]	IV infusion

Timeline

• Start date: 2020-04-30
• Primary completion: 2024-07-05
• Completion: 2024-07-05
• First posted: 2020-02-07
• Last updated: 2026-01-29
• Results posted: 2026-01-29

Locations

8 sites across 3 countries: France, Netherlands, Spain