Open Label, Multicenter Phase II Study of the C5A- Antibody IFX-1 Alone or IFX-1 + Pembrolizumab in Patients with PD-1- or PD-L1-Resistant/Refractory Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma (CSCC)
This is an open-label, non-randomized, Phase II study. Patients will be enrolled in 2 treatment arms (Arm A: IFX-1 monotherapy; Arm B: IFX-1 + pembrolizumab combination therapy).
- To assess the anti-tumor activity of IFX-1
- To determine the maximum tolerated dose or recommended Phase II dose
At least 18 years of age on day of signing informed consent
Patients with biopsy-proven, histologically or cytologically confirmed (a.) locally advanced cSCC not amenable for curative treatment or (b.) metastatic cSCC. Patients must have been treated with all approved therapies for (a.) inoperable locally advanced cSCC contraindicated for radiation therapy or (b.) metastatic cSCC
Eastern Cooperative Oncology Group performance status (ECOG PS) status of ≤1
Patients must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies.
Patient provides written informed consent for the study
Patients with limited cSCC, who do not require systemic therapy
Has a diagnosis of immunodeficiency or autoimmune disease, or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 3 weeks prior the first dose of study treatment
Has severe hypersensitivity (Grade 3 or higher) to pembrolizumab or IFX-1 and/or any of their excipients or had a severe (Grade 3 or higher) infusion-related reaction to treatments with other mAbs
Patients who have undergone major surgery > Patients with known Grade 3 or higher (per National Cancer Institute common terminology criteria for adverse events [NCI CTCAE] v5.0 criteria) active systemic or cutaneous viral, bacterial, or fungal infection
Has known active central nervous system metastases and/or carcinomatous meningitis.
Patients with a history of other malignancies during the past 5 years
Patients with congestive heart failure, Class III or IV, by New York Heart Association criteria
Patients who are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study,
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