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

Sponsor
Scancell Ltd
Study ID
NCT05329532
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 7, 2022
Status verified
Sep 2025
Primary completion
Jul 1, 2026
Completion
Jul 1, 2027

Study Design

Enrollment
168 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with TNBC, advanced/unresectable SCCHN, high grade serous ovarian carcinoma, or RCC
    Modi-1 Moditope Monotherapy
  • Experimental: Patients with advanced/unresectable SCCHN or RCC eligible for standard of care checkpoint inhibitors
    Modi-1 Moditope + Standard of Care Checkpoint Inhibitors
  • Experimental: Patients with SCCHN eligible for curative intent resection surgery (neoadjuvant cohort)
    Modi-1 Monotherapy vs Modi-1 Moditope + Pembrolizumab

Primary Outcome Measure

Incidence of clinical and laboratory adverse events (AEs) [ Time Frame: For the duration of the study (12 weeks after the final dose of study treatment) ]

Central Contacts

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