OSCAR I STUDY - The ONCObind CTC Removal Study

NCT06481397 | Completed DMC FDA Device

• 1 other identifier: Onco-Seraph-US23-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a Prospective Single Arm Open Label Feasibility trial to evaluate the initial safety and signal of efficacy of a novel extracorporeal blood purification (EBP) procedure in metastatic PDAC refractory to systemic therapy. Site selection will be dependent upon the site's familiarity with extracorporeal blood purification platforms as well as the diagnosis and management of PDAC. Adults (18 years old and older, ECOG PS of equal or less than 2) with a diagnosis of PDAC as defined histologically (microscopically) as a "pancreatobiliary type" adenocarcinoma with at least 5 U/mL CTCs in peripheral blood and/or portal vein.

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Outcome Measures

Primary Outcomes (5)

• Incidence of Procedure-Emergent Adverse Events Assessed by NCI CTCAE v5.0

  Incidence of treatment-emergent adverse events (AEs), graded using the NCI CTCAE Version 5.0.

  [Time Frame 30 days]

• Incidence of Procedure-Emergent Serious Adverse Events Assessed by NCI CTCAE v5.0

  Incidence of treatment-emergent serious adverse events (SAEs), graded using the NCI CTCAE Version 5.0.

  [Time Frame 30 days]

• Survival Follow-Up

  Survival Follow-Up (vital status)

  [Time Frame 60 days]

• Change in CTC Concentration

  The change in CTC concentration from baseline to the end of the induction series of Extracorporeal Procedure (ECPs) with Onco-Seraph 100.

  [Time Frame 30 days]

• Capacity for the Onco-Seraph 100 Filter to Remove Circulating Tumor Cells

  Capacity for the Onco-Seraph 100 filter to remove circulating tumor cells (CTCs) when compared to baseline.

  [Time Frame 60 days]

Secondary Outcomes (3)

• Incidence of Procedure-Emergent Adverse Events Assessed by NCI CTCAE v5.0

  [Time Frame 60 days]

• Incidence of Procedure-Emergent Serious Adverse Events Assessed by NCI CTCAE v5.0

  [Time Frame 60 days]

• Capacity for the Onco-Seraph 100 Filter to Remove Circulating Tumor Cells

  [Time Frame 30 days]

Study Arms (1)

ONCObind (Onco-Seraph) 100 Filter is a single use

EXPERIMENTAL

The Onco-Seraph 100 Filter is a single use, disposable column packed with ultra-high molecular weight polyethylene beads which have been modified to contain endpoint attached heparin on the surface. The devices are sterilized using a standard ethylene oxide cycle, following ISO 11135:2014/A1:2018. Chemical Indicator labels are located near the product label. A green label indicates that the device has been exposed to ethylene oxide gas. Onco-Seraph 100 is part of the Seraph platform technology that was also developed as an extracorporeal broad-spectrum sorbent hemoperfusion device for reduction of pathogens from the bloodstream.

Device: ONCObind (Onco-Seraph) 100 Filter

Interventions

ONCObind (Onco-Seraph) 100 Filter DEVICE

The ONCObind (Onco-Seraph) 100 Microbind® Affinity Blood Filter (Onco-Seraph 100) manufactured by ExThera Medical Corporation in Martinez, CA. The Onco-Seraph 100 filter has been designed and manufactured to reduce residual risks as much as possible to ensure safe usage. Literature search results concluded that heparin coated medical devices are safe and decrease platelet adhesion without affecting the adsorption of major adhesive proteins. Literature search yielded over 45 publications and 370 treated patients with Seraph platform technology for pathogen removals without significant safety concern. The achieved results from the above-mentioned testing and studies support the performance and safety of Onco-Seraph 100 consistent with the intended use. ExThera Medical concludes that the known and potential benefits of Onco-Seraph 100, when used to treat patients with PDAC, outweigh the known and potential risks when used according to the intended use.

ONCObind (Onco-Seraph) 100 Filter is a single use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years of age with metastatic pancreatic ductal carcinoma who experienced disease progression or not tolerating fluoropyrimidine-, oxaliplatin- and irinotecan- based regimens or prior treatment with gemcitabine and nab-paclitaxel.
• Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) scores of 2 or less.
• Patient or legally authorized representative is willing and able to understand and provide a signed informed consent that fulfills the relevant IRB or Independent Ethics Committee (IEC) guidelines.
• Patients with a CTC concentration of at least 5 cells/mL
• Must be willing to provide blood samples for prospective tumor molecular profiling and exploratory analyses.
• Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
• Female patients must be of non-childbearing potential or using a medically acceptable contraceptive regimen. Effective contraception includes surgical sterilization (e.g., vasectomy, tubal ligation), two forms of barrier methods (e.g., condom, diaphragm) used with spermicide, IUDs.
• Female patients must have a negative serum pregnancy test at Screening, and negative urine pregnancy test at baseline prior to dosing.
• Male patients must be surgically sterile or using a medically acceptable contraceptive regimen. Effective contraception includes surgical sterilization (e.g., vasectomy, tubal ligation), two forms of barrier methods (e.g., condom, diaphragm) used with spermicide, IUDs.

You may not qualify if:

• Pregnant or breast feeding
• Patients who cannot tolerate the placement of a dual lumen vascular access to enable extracorporeal treatment.
• Patients with a history of heparin induced thrombocytopenia (HIT).
• Patients with known allergy to heparin sodium.
• High risk of bleeding (platelet count \<50mm3 or International Normalized Ratio (INR) \>1.5)
• Hemodynamic instability and inability to tolerate extracorporeal procedure (defined as MAP\<65 despite fluids and vasopressors and or sustained hypotension at enrollment as defined by two readings with systolic blood pressure (SBP) measurements below 100 mmHg or diastolic blood pressure (DBP) measurements below 50 mmHg. The measurements must be performed thirty minutes from one another, and the Subject must be resting for at least 5 minutes prior to obtaining each measurement. (If the first reading includes a SBP greater than 100 mmHg and a DBP greater than 50 mmHg, the second reading does not need to be taken.
• Uncontrolled hypertension despite optimal management (systolic blood pressure \>150 mmHg or diastolic pressure \> 90mmHg).
• Ongoing uncontrolled, serious infection.
• Renal failure requiring dialysis.
• Patients with a life expectancy of less than 30 days.
• Pregnant and nursing women.
• Participation in an investigational drug study or history of receiving any investigational treatment within 14 days prior to initiation of treatment on this study.
• Concurrent participation in any interventional clinical trial or has been previously entered in this trial.
• The Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator.
• Unable to obtain informed consent from either patient or legally authorized representative (LAR)

Sponsors & Collaborators

• ExThera Medical Corporation: lead

Study Sites (1)

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Study Officials

• Lakhmir Chawla, MD

  ExThera Medical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Unblinded
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All study patients will be assigned to receive procedure with the investigational device (Onco-Seraph 100).

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 1, 2024
• Study Start: August 29, 2024
• Primary Completion: September 21, 2024
• Study Completion: October 18, 2024
• Last Updated: July 2, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)