Trials / Not Yet Recruiting

Not Yet RecruitingNCT06981806

Phase I Study of Cosibelimab and Balixafortide in Metastatic Pancreatic Ductal Adenocarcinoma

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

Status: Not Yet Recruiting
Phase: Phase 1
Study type: Interventional
Enrollment: 24 (estimated)

Sponsor: Arsen Osipov · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

Detailed 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 the assigned dose, until disease progression or unacceptable toxicity for up to 2 years.

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
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

Timeline

Start date: 2026-01-01
Primary completion: 2027-02-01
Completion: 2027-02-01
First posted: 2025-05-21
Last updated: 2025-11-19

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT06981806. Inclusion in this directory is not an endorsement.