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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and tolerability of two drugs, balixafortide and cosibelimab, for individuals with pancreatic cancer that has spread and worsened after standard chemotherapy. Participants will receive these drugs to help researchers determine their safety and how the body processes them. Those with pancreatic cancer that has progressed despite chemotherapy might be suitable candidates, particularly if their condition impacts daily activities. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive these new drugs.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on antiretroviral therapy for HIV, you must continue it throughout the study. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that cosibelimab and balixafortide are being tested together to assess their safety in treating pancreatic cancer. Previous studies have found that cosibelimab, which aids the immune system in fighting cancer, is generally well-tolerated. Approximately 47.4% of patients responded positively to the treatment, with manageable side effects.

Balixafortide has been less studied, but its safety is being tested in combination with cosibelimab. As this trial is in the early stages, the primary goal is to determine the safety of these treatments and identify any side effects. Consequently, limited safety information is currently available.

The fact that cosibelimab has been studied before and found safe in other contexts provides some reassurance. However, because this is early research, monitoring patients' reactions to both drugs together is crucial. Participants will be closely observed to manage any side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Cosibelimab and Balixafortide for pancreatic cancer because they represent a novel approach compared to the standard chemotherapy treatments like gemcitabine and FOLFIRINOX. Cosibelimab is an anti-PD-L1 monoclonal antibody that helps the immune system target and destroy cancer cells, offering a different mechanism of action than traditional chemotherapy. Balixafortide, meanwhile, is designed to enhance the immune response by blocking the CXCR4 receptor, which is often involved in cancer metastasis. This combination aims to boost the immune system's ability to fight cancer more effectively, potentially offering a new hope for patients with this challenging condition.

What evidence suggests that this trial's treatments could be effective for pancreatic cancer?

This trial will evaluate the combination of Cosibelimab and Balixafortide for pancreatic cancer. Research has shown that Cosibelimab may help the immune system attack cancer cells. In a previous study, almost 47% of participants responded positively to this treatment. Balixafortide blocks a pathway that cancer cells use to spread. In a small study, 64% of patients treated with both Cosibelimab and Balixafortide saw their tumors shrink. Additionally, 91% of patients managed to control their disease, suggesting that this combination can help manage cancer's progression. These findings indicate potential benefits for patients with advanced pancreatic cancer. ^{1 2 5 6 7}

Who Is on the Research Team?

Arsen Osipov, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

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

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. withpower.com withpower.com/trial/phase-1-adenocarcinoma-6-2025-38a7c

Cosibelimab + Balixafortide for Pancreatic Cancer This trial is for patients with advanced pancreatic cancer that has spread and who have already tried standard chemotherapy without success. Participants ...

2. ctv.veeva.com ctv.veeva.com/study/phase-i-study-of-cosibelimab-and-balixafortide-in-metastatic-pancreatic-ductal-adenocarcinoma

Phase I Study of Cosibelimab and Balixafortide in Metastatic ... This is a single-center, open-label, phase 1 dose escalation and dose expansion (safety confirmation) trial to evaluate the safety and ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.TPS4208

CheMo4METPANC: A randomized phase 2 study with ... Seven patients (64%) achieved a partial response, including 6 confirmed partial responses, and 10 patients (91%) had disease control, compared ...

4. phaseonefoundation.org phaseonefoundation.org/medical-grants

Medical Grants PHASE ONE has supported over 55 medical grants for innovative cancer clinical trials and treatments. See below for our past grant recipients.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37848259/

Efficacy and safety of cosibelimab, an anti-PD-L1 antibody, ... Results: Objective response was observed in 37 of 78 participants (47.4% (95% CI: 36.0% to 59.1%)), with median follow-up of 15.4 months (range: 0.4 to 40.5) as ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10582968/

Efficacy and safety of cosibelimab, an anti-PD-L1 antibody, in ... Objective response was observed in 37 of 78 participants (47.4% (95% CI: 36.0% to 59.1%)), with median follow-up of 15.4 months (range: 0.4 to ...

7. htsyndication.com htsyndication.com/us-fed-news/article/clinical-trial%3A-phase-i-study-of-cosibelimab-and-balixafortide-in-metastatic-pancreatic-ductal-adenocarcinoma/555731025

Phase I Study of Cosibelimab and Balixafortide in ... Brief Summary: This is a single-center, open-label, phase 1 dose escalation and dose expansion (safety confirmation) trial to evaluate the ...