Arsen Osipov
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.
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. In the dose escalation cohort, a maximum of 12 patients will be enrolled exploring three dose levels of balixafortide to identify the maximum tolerated dose (MTD) and recommended phase II dose (RP2D). Dosing of cosibelimab will remain constant (800 mg IV). Cosibelimab will be given IV every 2 weeks and balixafortide will be given IV weekly at th…
Inclusion Criteria * 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. * Written informed consent obtain…
Dose: 7.5 mg/kg Route: IV (2hr) Frequency: Weekly
Dose: 11 mg/kg Route: IV (2hr) Frequency: Weekly
Dose: 800 mg Route: IV (60 min) Frequency: Weekly
Dose: 16 mg/kg Route: IV (2hr) Frequency: Weekly
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