IIT2023-07-Osipov-CXCR4: Phase I Dose Escalation and Dose Expansion Study of Combination Immunotherapy With Cosibelimab and CXCR4 Inhibition With Balixafortide in Metastatic Treatment Refractory Pancreatic Ductal Adenocarcinoma

Arsen Osipov

Summary

Description

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…

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

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…

Interventions

Drug
Balixafortide
Dose: 7.5 mg/kg Route: IV (2hr) Frequency: Weekly
Drug
Balixafortide
Dose: 11 mg/kg Route: IV (2hr) Frequency: Weekly
Drug
Cosibelimab
Dose: 800 mg Route: IV (60 min) Frequency: Weekly
Drug
Balixafortide
Dose: 16 mg/kg Route: IV (2hr) Frequency: Weekly

Location

Cedars-Sinai Cancer at SOCC
Los Angeles, California