Cosibelimab + Balixafortide for Pancreatic Cancer

Overseen By Clinical Trial Navigator

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Arsen Osipov

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Immunodeficiency, Active CNS metastases, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Arsen Osipov, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

This trial is for patients with advanced pancreatic cancer that has spread and who have already tried standard chemotherapy without success. Participants should be able to perform daily activities with minimal assistance.

Inclusion Criteria

My cancer can be measured and has grown in previously treated areas.

Written informed consent obtained from subject and ability for subject to comply with the requirements of the study

I have another cancer, but it won't affect this trial's treatment.

Exclusion Criteria

I have been treated with specific immune therapy before.

Is currently participating in or has received an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment

I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Dose escalation cohort to identify the maximum tolerated dose (MTD) of balixafortide in combination with cosibelimab

Up to 2 years

Cosibelimab IV every 2 weeks, Balixafortide IV weekly

Dose Expansion

Dose expansion cohort to confirm safety at the maximum tolerated dose (MTD) of balixafortide

Up to 2 years

Cosibelimab IV every 2 weeks, Balixafortide IV weekly

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Treatment Details

Interventions

• Balixafortide
• Cosibelimab

Trial Overview The study tests the combination of two drugs, Cosibelimab and Balixafortide, in a single-center setting. It's an early-phase trial to find safe dosage levels and see how well these drugs are tolerated by patients.

Participant Groups

Group I: Treatment (Cosibelimab, Balixafortide) Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Arsen Osipov

Lead Sponsor