Phase 1 Trial of Intralesional Immunotherapy with IFx-Hu2.0 Vaccine in Patients with Advanced Merkel Cell Carcinoma or Cutaneous Squamous Cell Carcinoma
This is primarily a safety study that is designed to evaluate IFx-Hu2.0 monotherapy and provide foundational evidence to potentially support further studies investigating IFx-Hu2.0 + anti-PD-1 combination therapy for patients with advanced MCC or cSCC.
Primary Objective The primary objective is to assess the safety of vaccinating patients with advanced MCC or cSCC with intralesional IFx-Hu2.0. Secondary Objective Secondary objectives are to assess the feasibility of IFx-Hu2.0 administration and evaluate any preliminary efficacy in patients with advanced MCC or cSCC.
- Life expectancy greater than 3 months at recruitment
- Eastern Cooperative Oncology Group (ECOG) performance status >Males or females with histologically confirmed diagnosis of advanced Merkel cell carcinoma (MCC) or cutaneous squamous cell carcinoma (cSCC)
- Participants must have progressed despite standard therapy(ies) or are intolerant to or refused standard therapy(ies).
- Clinically measurable disease with at least 1 injectable lesion > 3 mm in longest diameter; an injectable lesion is defined as an easily palpable superficial lesion (cutaneous, subcutaneous or lymph nodal metastasis) that can be accurately localized, stabilized by palpation, and is superficial enough to enable intralesional injection.
- No known bleeding diathesis or coagulopathy that would make intratumoral injection or biopsy unsafe
- The entry laboratory criteria for subject eligibility must be met as defined by protocol
- Males and females of reproductive potential must agree to continuously use adequate contraception prior to study entry and for up to 6 months thereafter. A female is of childbearing potential unless she has had a surgical procedure that would accomplish sterility such a bilateral tubal ligation, hysterectomy or has not had menses for the past 12 months.
- Females of childbearing potential must have a negative urine or serum pregnancy test within one week prior to start of treatment
- Participant or legal representative must understand and sign a written informed consent form.
- Concurrent use of any other investigational product or participation in another trial within 28 days before start of study treatment.
- Have received oncologic therapy within 2 weeks of planned IFx-Hu2.0 injection
- Presence or history of central nervous system metastasis [treated/stable brain metastasis are allowable when Participants have received prior therapy for their brain metastases and their central nervous system (CNS) disease is radiographically stable (> 4 weeks)]
- Pregnant or breastfeeding females and females desiring to become pregnant or breastfeed within the timeframe of this study
- Concurrent steroid therapy (> 10 mg of daily prednisone equivalent) or other immunosuppressive therapies such as those needed for solid organ transplants and rheumatoid arthritis. Topical or inhaled steroids are allowable.
- History of organ allograft transplantation
- History of hemolytic anemia
- History of significant tumor bleeding, or coagulation or bleeding disorders.
- History of autoimmune disorder, with exception of Participants with vitiligo or endocrine-related autoimmune conditions receiving appropriate hormonal supplementation who are eligible; systemic use of immunosuppressant drugs such as steroids (except as hormone replacement therapy or short-course supportive medication such as chemotherapy or drug allergy, etc.), azathioprine, tacrolimus, cyclosporine, etc. within 4 weeks before recruitment
- Major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered major surgery) resulting from a prior surgery
- Leptomeningeal involvement regardless of treatment status
- Active, clinically serious infections or other serious uncontrolled medical conditions such as HIV, HBV, HCV, and EBV infection
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with protocol requirements
- Unwilling or unable to follow protocol requirements
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