Phase I Study of Cosibelimab and Balixafortide in Metastatic Pancreatic Ductal Adenocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorArsen Osipov
About this trial
This is a single-center, open-label, phase 1 dose escalation and dose expansion (safety confirmation) trial to evaluate the safety and tolerability of balixafortide and cosibelimab in patients with metastatic PDAC who progressed after SOC chemotherapy.
Eligibility criteria
Qualifiers
Patients must have histologically (cytology) confirmed pancreatic ductal adenocarcinoma (PDAC) that is metastatic or unresectable, with disease progression after standard of care (SOC) chemotherapy. Patients with clinical, radiologic, and/or pathologic evidence of metastatic disease after SOC chemotherapy are eligible.
Age 18 or older
ECOG Performance Status 0-2
Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Disqualifiers
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
Is currently participating in or has received an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
Trial design
Treatments tested in this trial
- Balixafortide
- Balixafortide
- Cosibelimab
- Balixafortide
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Arsen Osipov
Lead sponsor
Cedars-Sinai Medical Center
Sponsor institution
Source ClinicalTrials.gov