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

ConditionMetastatic Pancreatic Ductal Adenocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorArsen Osipov

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Balixafortide

    Drug

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

  • Balixafortide

    Drug

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

  • Cosibelimab

    Drug

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

  • Balixafortide

    Drug

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

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Treatment (Cosibelimab, Balixafortide)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

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

Time frame
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

Time frame
2 Years

Secondary outcomes

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

Time frame
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

Time frame
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.

Time frame
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

Time frame
3 Years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arsen Osipov

Lead sponsor

Cedars-Sinai Medical Center

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: