MedTrace Logo

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

NCT06981806 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-11-19

No results posted yet for this study

Summary

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.

Conditions

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

Sponsors & Collaborators

  • Arsen Osipov

    lead OTHER

Principal Investigators

  • Arsen Osipov, MD · Cedars-Sinai Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-02-28
Completion
2027-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06981806 on ClinicalTrials.gov