NCT05329532

Modi-1 Moditope in Breast, Head and Neck, Ovarian, or Renal Cancer

A Phase 1/2, Multicentre, Open-Label Study of Modi-1 Moditope in Patients With Breast, Head and Neck, Ovarian, or Renal Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Scancell Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objectives of this study are to assess the safety, tolerability, immunological activity, and preliminary efficacy of the Modi-1 Moditope vaccine, both as monotherapy and in combination with a checkpoint inhibitor (CPI) such as pembrolizumab or nivolumab with or without Ipilimumab (where these are standard of care in a non-neoadjuvant setting), in patients with advanced triple negative breast cancer (TNBC), advanced/unresectable human papillomavirus-negative squamous cell carcinoma of the head and neck (SCCHN), high grade serous ovarian carcinoma (HGSOC), or renal cell carcinoma (RCC). Modi-1 Moditope will also be investigated in the neoadjuvant setting for patients with SCCHN undergoing curative intent surgical resection in combination with pembrolizumab versus the Modi-1 alone.

Detailed description

This is an open-label, parallel arm, Phase 1/2 study to assess the safety, tolerability, immunological activity, and preliminary efficacy of the Modi-1 Moditope vaccine in patients with advanced TNBC, advanced/unresectable SCCHN, HGSOC, or RCC. Modi-1 Moditope vaccines, consist of a combination of specific peptides conjugated to a toll-like receptor ligand 1/2 adjuvant, designed to enhance immune responses against peptides commonly expressed or upregulated by cancer cells. Thus, improving immune recognition of these cancers and potentially increasing response rates in patients with advanced solid tumours. The aim of this study is to investigate preliminary efficacy of Modi-1 Moditope, in an open labelled clinical trial, in participants with TNBC, SCCHN, RCC and HGSOC, powered to demonstrate that Modi-1 Moditope have potent anti-tumour activity. In this trial, Modi-1 Moditope will be administered, either as monotherapy or in combination with a CPI (as standard of care). In addition, an exploratory, randomised cohort will be included to assess the impact of Modi-1 Moditope (with or without pembrolizumab) in participants with SCCHN scheduled for resection surgery with curative intent. Modi-1 Moditope will be administered intradermally using the MicronJet600™ microneedle device referred to as NanoPass. The study aims to enrol 168 (138 in non-neoadjuvant cohorts and 30 in the exploratory neoadjuvant SCCHN cohort) individuals across multiple UK collaborating clinical centres.

Conditions

• Triple Negative Breast Cancer
• Renal Cell Cancer
• High Grade Ovarian Serous Adenocarcinoma
• Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
BIOLOGICAL	Modi-1 Moditope	Modi-1 Moditope administered intradermally (i.d.) using the MicronJet600™ microneedle device (NanoPass).
BIOLOGICAL	Pembrolizumab	Pembrolizumab (exploratory cohorts) will be administered by intravenous infusion on Day 8, prior to tumour resection surgery at 6 weeks.
DEVICE	MicronJet600™ microneedle device (NanoPass)	Intradermal injection device

Timeline

• Start date: 2022-04-07
• Primary completion: 2026-07-01
• Completion: 2027-07-01
• First posted: 2022-04-15
• Last updated: 2025-09-17

Locations

16 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study
• FDA-regulated device study