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

First listed
Apr 15, 2022
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) ]

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