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Modi-1 Moditope in Breast, Head and Neck, Ovarian, or Renal Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

NCT05329532•Scancell Ltd

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient either has one of the following histologically or cytologically confirmed advanced cancers not amenable to curative intent surgical resection:
•* TNBC
•* SCCHN (oral cavity, oropharynx, hypopharynx, or larynx)
•* HGSOC including fallopian tube and primary peritoneal cancers
•* RCC Or the patient has histologically or cytologically confirmed SCCHN scheduled to have curative intent surgical resection.
•2. Patient must meet one of the following specific criteria for prior treatment of the relevant tumour type:
•* TNBC:
•* patient has received available standard therapy for advanced disease (Modi-1ev/Modi-1eKv monotherapy cohort only).
•* patient stopped immunotherapy due to toxicity and with residual disease as measurable by RECIST 1.1 (Modi-1ev/Modi-1eKv monotherapy cohort only).
•* patient completing a systemic treatment regimen with immunotherapy, for whom a subsequent SOC therapy is not yet indicated or appropriate and with measurable disease in accordance with RECIST 1.1 (Modi-1ev/Modi-1eKv monotherapy cohort only).
+25 more criteria

Exclusion Criteria

•5. Patient has recovered to Grade ≤1 (CTCAE v5.0) from the effects (excluding alopecia) of any prior therapy for their malignancies.
•6. Patient has at least one measurable lesion per RECIST 1.1 criteria by computed tomography (CT) scan or magnetic resonance imaging (MRI) (non-neoadjuvant cohorts).
•7. Wherever possible, patients not scheduled for curative intent resection surgery should have a fresh tumour biopsy (or have an archival biopsy \[obtained within the past 5 years\] if obtaining a fresh biopsy is not feasible) at baseline for molecular studies, and agree to a post-treatment biopsy (at Week 25 or one of the EOT visits), if feasible. Patients in the SCCHN neoadjuvant cohort must have both a fresh pre-treatment biopsy and agree to have their resected tumour analysed.
•8. Patient is male or female and at least 18 years of age.
•9. Patient has a life expectancy of more than 6 months.
•10. Patient has an ECOG performance status of 0 or 1.
•11. Patient has adequate organ function as determined by the following laboratory values: absolute neutrophil count ≥1.5 x 109/L, platelets ≥100 x 109/L, haemoglobin \>90 g/L (\>5.6 mmol/L), lymphocytes ≥ 1 x 109/L, serum creatinine ≤1.5 x upper limit of the normal range (ULN), serum total bilirubin ≤1.5 x ULN, serum transaminases (aspartate aminotransferase \[AST\]/alanine aminotransferase \[ALT\]) ≤2.5 x ULN or ≤5.0 x ULN if liver metastases present.
•12. Patient must be able and willing to provide written informed consent prior to any study related procedure. (In the event that the patient is re-screened for study participation or if a protocol amendment alters the care of an ongoing patient, a new informed consent form must be signed).
•13. Women of child-bearing potential must have a negative serum pregnancy test during Screening (and a urine test within the 7 days prior to Day 1) and be neither breastfeeding nor intending to become pregnant during study participation. Women of child-bearing potential must agree to use highly effective contraceptive methods prior to study entry, for the duration of study participation, and for 120 days after discontinuation of vaccine monotherapy or 5 months after use with a CPI (or longer if the Summary of Product Characteristics \[SmPC\] of the CPI requires it).
•14. Men who are potentially fertile with partners of child-bearing potential must agree to use highly effective contraceptive methods for the duration of study participation, and for 120 days after discontinuation of vaccine monotherapy or 5 months after use with a CPI (or longer if the SmPC of the CPI requires it).
+15 more criteria

Locations (16)

Brighton and Sussex University Hospital

Brighton, Default, United Kingdom

Velindre Cancer Centre

Cardiff, Default, United Kingdom

Edinburgh Cancer Centre (NHS Lothian)

Edinburgh, Default, United Kingdom

Royal Surrey NHS Foundation

Guildford, Default, United Kingdom

Imperial College Healthcare NHS Trust

London, Default, United Kingdom

Mount Vernon

London, Default, United Kingdom

University College London Hospital NHS Foundation Trust

London, Default, United Kingdom

Christie NHS Foundation Trust

Manchester, Default, United Kingdom

Nottingham University Hospitals Cancer Centre

Nottingham, Default, United Kingdom

Lancashire Teaching Hospitals NHS Foundation Trust

Preston, Default, United Kingdom

Key Dates

Start Date

April 7, 2022

Primary Completion Date

July 1, 2026

Completion Date

July 1, 2027

Last Updated

September 17, 2025

Enrollment

168

ESTIMATED participants

Conditions

Triple Negative Breast CancerRenal Cell CancerHigh Grade Ovarian Serous AdenocarcinomaSquamous Cell Carcinoma of the Head and Neck

Interventions

Modi-1 Moditope

BIOLOGICAL

Pembrolizumab

BIOLOGICAL

MicronJet600™ microneedle device (NanoPass)

DEVICE

Contacts

Robert Miller

CONTACT

+441865582690 info@scancell.co.uk

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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