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

NCT05329532 | Recruiting Phase 1 FDA Drug FDA Device

• 1 other identifier: Modi-1-001
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

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

Keywords

vaccine; peptide; Phase II

Outcome Measures

Primary Outcomes (2)

• Incidence of clinical and laboratory adverse events (AEs)

  To measure the incidence of AEs of Modi-1 Moditope (as monotherapy and in combination with a CPI (e.g., pembrolizumab or nivolumab provided as standard of care) when administered intradermally

  For the duration of the study (12 weeks after the final dose of study treatment)

• Cellular immune response to Modi-1 Moditope on IFNγ ELISpot assay

  (i) the mean peptide-specific ELISpot response minus two standard deviations is greater than the mean pre-treatment peptide-specific response plus one standard deviation (of this mean); and (ii) the ELISpot response is more than 50 spots per million peripheral blood mononuclear cells.

  For the duration of the study (12 weeks after the final dose of study treatment)

Secondary Outcomes (5)

• Imaging Response using RECIST 1.1 and iRECIST to Modi-1 Moditope in the non-neoadjuvant setting

  For the duration of the study (12 weeks after the final dose of study treatment)

• Overall survival

  For the duration of the study (12 weeks after the final dose of study treatment)

• Progression-free survival in patients vaccinated with Modi-1 Moditope

  For the duration of the study (12 weeks after the final dose of study treatment)

• Pathological response in the neoadjuvant setting in patients vaccinated with Modi-1 Moditope or Modi-1 Moditope + Pembrolizumab

  For the duration of the study (6 weeks after resection surgery)

• Celluar immune response in the neoadjuvant setting in patients vaccinated with Modi-1 Moditope or Modi-1 Moditope + Pembrolizumab

  For the duration of the study (6 weeks after resection surgery)

Other Outcomes (2)

• Immune cell profiling in tumour samples

  For the duration of the study (12 weeks after the final dose of study treatment)

• Measurement of circulating tumour deoxyribonucleic acid (ctDNA)

  For the duration of the study (12 weeks after the final dose of study treatment)

Study Arms (3)

Patients with TNBC, advanced/unresectable SCCHN, high grade serous ovarian carcinoma, or RCC

EXPERIMENTAL

Modi-1 Moditope Monotherapy

Biological: Modi-1 Moditope; Device: MicronJet600™ microneedle device (NanoPass)

Patients with advanced/unresectable SCCHN or RCC eligible for standard of care checkpoint inhibitors

EXPERIMENTAL

Modi-1 Moditope + Standard of Care Checkpoint Inhibitors

Biological: Modi-1 Moditope; Device: MicronJet600™ microneedle device (NanoPass)

Patients with SCCHN eligible for curative intent resection surgery (neoadjuvant cohort)

EXPERIMENTAL

Modi-1 Monotherapy vs Modi-1 Moditope + Pembrolizumab

Biological: Modi-1 Moditope; Biological: Pembrolizumab; Device: MicronJet600™ microneedle device (NanoPass)

Interventions

Modi-1 Moditope BIOLOGICAL

Modi-1 Moditope administered intradermally (i.d.) using the MicronJet600™ microneedle device (NanoPass).

Patients with SCCHN eligible for curative intent resection surgery (neoadjuvant cohort); Patients with TNBC, advanced/unresectable SCCHN, high grade serous ovarian carcinoma, or RCC; Patients with advanced/unresectable SCCHN or RCC eligible for standard of care checkpoint inhibitors

Pembrolizumab BIOLOGICAL

Pembrolizumab (exploratory cohorts) will be administered by intravenous infusion on Day 8, prior to tumour resection surgery at 6 weeks.

Patients with SCCHN eligible for curative intent resection surgery (neoadjuvant cohort)

MicronJet600™ microneedle device (NanoPass) DEVICE

Intradermal injection device

Patients with SCCHN eligible for curative intent resection surgery (neoadjuvant cohort); Patients with TNBC, advanced/unresectable SCCHN, high grade serous ovarian carcinoma, or RCC; Patients with advanced/unresectable SCCHN or RCC eligible for standard of care checkpoint inhibitors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).
• patient has refused SOC therapy (Modi-1ev/Modi-1eKv monotherapy cohort only).
• SCCHN:
• patient has received first-line platinum-containing chemotherapy (with or without radiotherapy) as treatment for advanced disease (Modi-1ev/Modi-1eKv monotherapy and Modi-1ev/Modi-1eKv + CPI cohorts).
• patient with locally advanced or metastatic disease measurable by RECIST 1.1 for whom all forms of platinum-based chemoradiotherapy treatment are contraindicated (Modi-1ev/Modi-1eKv monotherapy and Modi-1ev/Modi-1eKv + CPI cohorts).
• patient completing 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).

You may not qualify if:

• Patient has symptomatic central nervous system metastases or carcinomatous meningitis.
• Patient is taking any systemic steroid therapy (exceeding 10 mg/day of prednisolone or equivalent) or is on any other form of immune suppressant medication within 2 weeks prior to the first dose of IMP. Physiological doses of systemic steroids such as those for the management of adrenal insufficiency, topical and inhaled steroids, such as those for the management of asthma, and patients with hypothyroidism stable on hormone replacement, are permitted.
• Patient has a history of malignancy other than the disease under study within 2 years prior to Screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 2-year overall survival rate \>90%), such as adequately treated carcinoma-in-situ of the breast or the cervix, melanoma-in-situ, non-melanoma skin carcinoma, superficial bladder cancer, prostate cancer with Gleason grade ≤6 and prostate specific antigen within normal range or stage I endometrial cancer.
• Patient is pregnant, lactating, or is expecting to conceive/father children within the duration of the study.
• Patient has a concurrent illness which would preclude study conduct and assessment, including, but not limited to, uncontrolled medical conditions, uncontrolled and active infection (considered opportunistic, life threatening, or clinically significant), uncontrolled risk of bleeding, uncontrolled diabetes mellitus, pulmonary disease (including obstructive pulmonary disease and pulmonary fibrosis), alcoholic liver disease, or primary biliary cirrhosis.
• Patient has New York Heart Association (NYHA) class III or IV heart disease, myocardial infarction or stroke within previous 6 months, a history of significant cardiac abnormality and/or significant abnormal baseline ECG readout, active ischaemia, or any other uncontrolled cardiac condition such as angina pectoris, clinically significant arrhythmia requiring therapy, uncontrolled hypertension, significant cerebrovascular disease, or congestive heart failure.
• Patient has anti-CCP antibody levels classified as equivocal or positive according to NHS guidelines, i.e., ≥ the ULN, or has an active autoimmune disease that may impact on the study treatment in the opinion of the Investigator.
• Patient has received a live vaccine within 28 days, or an influenza vaccine within 14 days prior to the first dose of IMP. The timing of any other vaccines should be assessed on a case-by-case basis by the Investigator prior to study enrolment.
• Patient has a known history of human immunodeficiency virus (HIV), hepatitis B virus (HBV; surface antigen reactive) or hepatitis C (HCV; RNA detected).
• COVID-19 vaccination within 14 days prior to the first dose of IMP.
• Patient has a known current or recent history (within the last year) of substance abuse including illicit drugs or alcohol.
• History of any of the following: drug-induced severe cutaneous adverse reaction (SCAR; including, but not limited to Stevens-Johnson syndrome/toxic epidermal necrolysis \[SJS/TEN\], or drug reaction with eosinophilia and systemic symptoms \[DRESS\]), or dose-limiting immune-mediated reactions (Modi-1ev/Modi-1eKv + CPI RCC cohort only).
• Patient has a known hypersensitivity to the IMP under study or their excipients. Where SOC CPIs are planned to be given with the IMP, the patient must not have a known hypersensitivity to the CPIs or their excipients.

Sponsors & Collaborators

• Scancell Ltd: lead

Study Sites (16)

Brighton and Sussex University Hospital

Brighton, Default, United Kingdom

ACTIVE NOT RECRUITING

Velindre Cancer Centre

Cardiff, Default, United Kingdom

RECRUITING

Edinburgh Cancer Centre (NHS Lothian)

Edinburgh, Default, United Kingdom

RECRUITING

Royal Surrey NHS Foundation

Guildford, Default, United Kingdom

RECRUITING

Imperial College Healthcare NHS Trust

London, Default, United Kingdom

ACTIVE NOT RECRUITING

Mount Vernon

London, Default, United Kingdom

RECRUITING

University College London Hospital NHS Foundation Trust

London, Default, United Kingdom

RECRUITING

Christie NHS Foundation Trust

Manchester, Default, United Kingdom

RECRUITING

Nottingham University Hospitals Cancer Centre

Nottingham, Default, United Kingdom

RECRUITING

Lancashire Teaching Hospitals NHS Foundation Trust

Preston, Default, United Kingdom

RECRUITING

Sheffield Teaching Hospital NHS Foundation Trust

Sheffield, Default, United Kingdom

RECRUITING

The Royal Marsden NHS Foundation Trust

Sutton, Default, United Kingdom

NOT YET RECRUITING

Belfast City Hospital

Belfast, United Kingdom

RECRUITING

Addenbrooke's Hospital, Cambridge University Hospitals

Cambridge, United Kingdom

RECRUITING

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, CH63 4JY, United Kingdom

RECRUITING

Torbay and South Devon NHS Foundation Trust

Torquay, United Kingdom

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Carcinoma, Renal Cell; Squamous Cell Carcinoma of Head and Neck

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma, Squamous Cell; Head and Neck Neoplasms

Study Officials

• Christian Ottensmeier, MD

  The Clatterbridge Cancer Centre NHS Foundation Trust, United Kingdom

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Miller

CONTACT

+441865582690; info@scancell.co.uk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, uncontrolled study.

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: April 15, 2022
• Study Start: April 7, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (16)