Non-comparative Study of IFX-1 Alone or IFX-1+Pembrolizumab in Patients With Locally Advanced or Metastatic cSCC.
a study on SSC Squamous Cell Carcinoma
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at La Jolla, California and other locations
- Dates
- study startedestimated completion
Description
Summary
This is an open-label, "non comparative", non-randomized, Phase II study. Patients will be enrolled in 2 treatment arms
Official Title
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)
Details
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), both consisting of 2 stages whereas Arm B starts with a safety run in portion. Enrollment follows an optimal Simon's 2-stage design with an interim analysis of treatment response after Stage 1 prior to patient enrollment into Stage 2.
Arm B will start after ≥3 patients have been treated in Arm A and no toxicity concerns have emerged. In a safety run-in part of Arm B, escalating doses of IFX-1 will be investigated in combination with pembrolizumab in order to identify the MTD or RP2D. Patients will be treated until progression, occurrence of unacceptable toxicity, or treatment discontinuation for any other reason.
Keywords
SSC, SCC, metastatic, locally advanced, Pembrolizumab, Vilobelimab, IFX-1, IFX-1 + pembrolizumab combination therapy, IFX-1 monotherapy
Eligibility
You can join if…
Open to people ages 18 years and up
- 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.
You CAN'T join if...
- 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) to pembrolizumab or IFX-1 and/or any of their excipients or had a severe (≥Grade 3) infusion-related reaction to treatments with other mAbs
- Patients who have undergone major surgery <4 weeks prior to starting study treatment
- Patients with known ≥Grade 3 (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,
Locations
- UC San Diego Moores Cancer Center
accepting new patients
La Jolla California 92093 United States - Anschutz Cancer Pavilion
accepting new patients
Aurora Colorado 80045 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- InflaRx GmbH
- ID
- NCT04812535
- Phase
- Phase 2 research study
- Study Type
- Interventional
- Participants
- Expecting 70 study participants
- Last Updated
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
Thank you!
The study team should get back to you in a few business days.