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

Phase 1

Not yet recruiting

• Conditions: Metastatic Pancreatic Ductal Adenocarcinoma
• Interventions: Drug: Balixafortide; Drug: Cosibelimab

• Registration Number: NCT06981806
• Lead Sponsor: Arsen Osipov

Brief 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.

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-13
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21
• Study Start: 2025-07
• Primary Completion: 2027-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (Cosibelimab, Balixafortide)	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
Treatment (Cosibelimab, Balixafortide)	Cosibelimab	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 Measures

Name	Time	Method
MTD of Balixafortide	2 Years	To identify the MTD of balixafortide in combination with cosibelimab in patients with metastatic treatment refractory PDAC with progressive disease after SOC chemotherapy
RP2D of Balixafortide	2 Years	To identify the RP2D of balixafortide in combination with cosibelimab in patients with metastatic treatment refractory PDAC with progressive disease after SOC chemotherapy

Secondary Outcome Measures

Name	Time	Method
Toxicity Profile of Balixafortide	3 Years	To assess the toxicity profile of balixafortide in combination with cosibelimab in patients with metastatic treatment refractory PDAC with progressive disease after SOC chemotherapy
Anti-tumor Activity - PFS	3 Years	To evaluate the anti-tumor activity of combination balixafortide and cosibelimab in patients with metastatic treatment refractory PDAC progressed on SOC chemotherapy. Progression Free Survival (PFS) :The length of time from the first dose of study treatment to disease progression according to RECIST 1.1 criteria
Anti-tumor Activity - OS	3 Years	To evaluate the anti-tumor activity of combination balixafortide and cosibelimab in patients with metastatic treatment refractory PDAC progressed on SOC chemotherapy. OS (Overall Survival): The length of time from first dose of study treatment to death of any cause.
Safety Profile of Balixafortide	3 Years	To assess the safety profile of balixafortide in combination with cosibelimab in patients with metastatic treatment refractory PDAC with progressive disease after SOC chemotherapy
Anti-tumor Activity - ORR	3 Years	To evaluate the anti-tumor activity of combination balixafortide and cosibelimab in patients with metastatic treatment refractory PDAC progressed on SOC chemotherapy. Overall Response Rate (ORR): Radiologic tumor responses (CR, PR) as determined by RECIST 1.1 criteria.

Trial Locations

Locations (1)

Cedars-Sinai Cancer at SOCC; 🇺🇸 Los Angeles, California, United States