Clinical trialPhase 1Not yet recruiting
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
- Outcome
- Ongoing
- Phase
- Phase 1
- Status
- Not yet recruiting
- Study type
- Interventional
- Start
- January 2026
- Expected end
- February 2027
- Enrollment
- 24 participants
- Sites
- 1
- Primary outcomes
- MTD of Balixafortide; RP2D of Balixafortide
- Sponsor
- Other
- Results posted
- No
- Last update
- 19 November 2025
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
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.