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Phase 1 Study of Cosibelimab and Balixafortide for Metastatic Pancreatic Cancer

This study is testing two drugs, cosibelimab and balixafortide, for people with metastatic pancreatic ductal adenocarcinoma (PDAC), a type of pancreatic cancer that has spread. You may be able to join if your cancer has progressed after standard chemotherapy. This is a Phase 1 study, meaning researchers are primarily looking at the safety and how well different doses of balixafortide are tolerated when given with a constant dose of cosibelimab. The goal is to find the safest and most effective dose of balixafortide. Up to 24 people are planned to enroll in this study. The study status is currently unclear.

Study design
This is a single-center, open-label, Phase 1 study. It will enroll up to 24 participants to test different doses of balixafortide with a constant dose of cosibelimab.
What's involved
You would receive cosibelimab intravenously (IV) every two weeks and balixafortide IV weekly. Treatment continues until your disease progresses or side effects become too severe, for up to two years.
Compensation
Not stated in the trial record.
Follow-up
The primary safety endpoints for balixafortide are measured at 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06981806

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

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
Arsen Osipov
~24 participants
Updated 2025-11-19 on ClinicalTrials.gov
What's tested:BalixafortideCosibelimab

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
MTD of Balixafortide
Measured over 2 Years
+1 more outcome measured

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma

Explore related trials

Pancreatic Ductal Adenocarcinoma

NCT06981806

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cedars-Sinai Cancer at SOCC

    Los Angeles, Californiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Arsen Osipov, MD · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center

Who to contact

Clinical Trial Navigator
[email protected]
3104232133
Email the study team

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Eligibility criteria

Inclusion

Patients must have histologically (cytology) confirmed pancreatic ductal adenocarcinoma (PDAC) that is metastatic or unresectable, with disease progression after standard of care (SOC) chemotherapy. Patients with clinical, radiologic, and/or pathologic evidence of metastatic disease after SOC chemotherapy are eligible.
Age 18 or older
ECOG Performance Status 0-2
Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
All patients must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for 120 days after the last dose of study treatment.
Participants who are HbsAg positive are eligible if they have undetectable HBV viral load prior to screening and have received HBV anti-viral therapy for at least 4 weeks prior to first dose of study treatment. Hepatitis B screening tests are not required unless the participant has a known history of HBV infection.
Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening and have completed curative anti-viral therapy at least 4 weeks prior to first dose of study treatment. Hepatitis C screening tests are not required unless the participant has a known history of HCV infection.
HIV-infected participants must have well-controlled HIV on antiretroviral therapy (ART), defined as:
Have adequate organ function as defined in the following table. Specimens must be collected within 3 days prior to the start of study intervention.

Exclusion

Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
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.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
Has severe hypersensitivity (≥Grade 3) or history of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study: Cosibelimab and Balixafortide.
Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid)
Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Has an uncontrolled, active infection requiring systemic treatment. Patients with an infection that is controlled with oral or IV anti-microbials (e.g., UTI with short term antibiotic course), adequate source control, and no evidence of worsening clinical status are eligible.
Has not adequately recovered from major surgery or has ongoing surgical complications.
Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Is pregnant or breastfeeding or planning to conceive children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
Has a history of any organ transplant (e.g., allogeneic stem cell transplant, solid organ transplant, corneal transplant)

What this trial measures

  • MTD of Balixafortide2 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 Balixafortide2 Years

    To identify the RP2D of balixafortide in combination with cosibelimab in patients with metastatic treatment refractory PDAC with progressive disease after SOC chemotherapy