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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Arsen Osipov
Study ID
NCT06981806
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Metastatic Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 31, 2026
Status verified
Nov 2025
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Cosibelimab, Balixafortide)
    Dose escalation cohort: Cosibelimab 800 mg IV Q2W + dose escalation of balixafortide IV weekly. Dose expansion cohort: Cosibelimab 800 mg IV Q2W + balixafortide IV weekly at the MTD

Primary Outcome Measure

MTD of Balixafortide [ Time Frame: 2 Years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Cancer at SOCCLos AngelesCalifornia90048-

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Cancer at SOCC· Los Angeles, CA

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