AzTrials
AzTrials

Metastatic Pancreatic Ductal AdenocarcinomaPhase 1NCT06981806

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

A Phase 1 study testing Balixafortide and Cosibelimab in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Arsen Osipov at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Balixafortide and Cosibelimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
Jan 2026to Feb 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 15Show fewer
  • 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:
  • Participants on ART must have a CD4+ T-cell count ≥350 cells/mm3 at the time of screening
  • Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening
  • Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study
  • Have adequate organ function as defined in the following table. Specimens must be collected within 3 days prior to the start of study intervention.
  • System Laboratory Value Hematological Absolute neutrophil count (ANC) ≥1000/µL Platelets ≥75,000/µ Renal Creatinine OR Measured or calculateda creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN Hepatic Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN (Except patients with Gilbert syndrome, who may enroll as long as total bilirubin AST (SGOT) and ALT (SGPT) ≤3.0 × ULN (≤5 × ULN for participants with liver metastases) Coagulation International normalized ratio (INR) OR Prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal. a Creatinine clearance (CrCl) should be calculated per institutional standard

Who cannot join

  • 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.
Show all 14Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trial Navigator contact

3104232133

cancer.trial.info@cshs.org

United States1 site

  • Cedars-Sinai Cancer at SOCC

    Los Angeles, California, 90048

Other trials in United States

About this study

Official title: 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

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.

Read the 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.

Being tested
Balixafortide, Cosibelimab
Keywords
Chemotherapy, Cosibelimab, Balixafortide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BalixafortideDrug

    Also called Dose Level 1 - Balixafortide 7.5 mg/kg

    Dose: 7.5 mg/kg Route: IV (2hr) Frequency: Weekly

  • BalixafortideDrug

    Also called Dose Level 2 - Balixafortide 11 mg/kg

    Dose: 11 mg/kg Route: IV (2hr) Frequency: Weekly

  • CosibelimabDrug

    Dose: 800 mg Route: IV (60 min) Frequency: Weekly

  • BalixafortideDrug

    Also called Dose Level 1 - Balixafortide 16 mg/kg

    Dose: 16 mg/kg Route: IV (2hr) Frequency: Weekly

Study groups in NCT06981806
Study groupRoleWhat they receive
Treatment (Cosibelimab, Balixafortide)ExperimentalDose 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
Receives: Drug: Balixafortide; Drug: Cosibelimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD of Balixafortide

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

    Measured: 2 Years

  2. RP2D of Balixafortide

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

    Measured: 2 Years

Secondary outcomes (5)

  1. Safety Profile of Balixafortide

    To assess the safety profile of balixafortide in combination with cosibelimab in patients with metastatic treatment refractory PDAC with progressive disease after SOC chemotherapy

    Measured: 3 Years

  2. Toxicity Profile of Balixafortide

    To assess the toxicity profile of balixafortide in combination with cosibelimab in patients with metastatic treatment refractory PDAC with progressive disease after SOC chemotherapy

    Measured: 3 Years

  3. Anti-tumor Activity - ORR

    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.

    Measured: 3 Years

  4. Anti-tumor Activity - PFS

    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

    Measured: 3 Years

  5. Anti-tumor Activity - OS

    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.

    Measured: 3 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2025
  2. Study startJan 2026 (estimated)
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06981806
Sponsor's protocol ID
IIT2023-07-Osipov-CXCR4
Status last verified
Nov 2025
First submitted
13 May 2025
Last updated
19 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Balixafortide and Cosibelimab in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Arsen Osipov at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trial Navigator (3104232133, cancer.trial.info@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD of Balixafortide (time frame: 2 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06981806.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in