OSCAR II STUDY - The ONCObind CTC Removal Study

NCT06655142 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: Onco-Seraph-US23-002
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a Prospective Single Arm, dual cohort Open Label Feasibility trial to evaluate the initial safety and signal of efficacy of a novel extracorporeal blood purification (EBP) procedure in either mPDAC or mCRC 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 mPDAC and mCRC. Adults (18 years old and older, ECOG PS of equal or less than 2) with a diagnosis of either mPDAC as defined histologically (microscopically) as a "pancreatobiliary type" adenocarcinoma who experienced disease progression or not tolerating fluoropyrimidine-, oxaliplatin- and irinotecan- based regimens or prior treatment with gemcitabine and nab-paclitaxel or are not candidates for chemotherapy or mCRC patients who experienced disease progression on 5-fluorouracil (5-FU), capecitabine, oxaliplatin and irinotecan as FOLFIRI and/or FOLFOX and/or XELOX and/or XELIR and/or FOLFOXIRI/FOLFIRINOX or who are not candidates for chemotherapy with at least 5 cells/mL CTCs in peripheral blood and/or portal vein.

Conditions

Pancreatic Ductal Adenocarcinoma (mPDAC); Metastatic Colorectal Carcinoma (mCRC)

Outcome Measures

Primary Outcomes (6)

• Incidence of procedure-emergent adverse events (AEs) graded using the NCI CTCAE Version 5.0

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

  210 days

• Incidence of procedure-emergent serious adverse events (SAEs) graded using the NCI CTCAE Version 5.0

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

  210 days

• Evaluation of Survival

  Survival follow-up will be assessed after enrollment (vital status check)

  60, 120, 180 and 210 days

• Change in CTC Concentration

  The change in CTC concentration from baseline to the end of the induction series as well as 180 days after baseline of Extracorporeal Procedure (ECPs) with ONCObind

  180 days

• Capacity for the ONCObind filter to remove circulating tumor cells

  Capacity for the ONCObind filter to remove circulating tumor cells (CTCs) when compared to baseline

  60 days

• Evaluate the Quality of Life (QOL)

  To evaluate the Quality of Life from baseline to end of study using the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30)

  210 days

Study Arms (2)

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

EXPERIMENTAL

The ONCObind 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 11135-1:2007. Chemical Indicator labels are located near the product label. ONCObind 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

Matched Controls

OTHER

Study patients will be assigned to receive procedure with the investigational device (ONCObind) and will be matched with 60 site specific controls, 30 PDAC and 30 CRC.

Other: Matched Controls

Interventions

ONCObind (Onco-Seraph) 100 Filter DEVICE

The ONCObind Microbind® Affinity Blood Filter ( ONCObind) manufactured by ExThera Medical Corporation in Martinez, CA. The ONCObind 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 60 publications and 500 treated patients with Seraph platform technology for pathogen removals without and significant safety concern. The achieved results from the above-mentioned testing and studies support the performance and safety of ONCObind consistent with the intended use. ExThera Medical concludes that the known and potential benefits of ONCObind, 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

Matched Controls OTHER

Study patients will be assigned to receive procedure with the investigational device (ONCObind) and will be matched with 60 site specific controls, 30 PDAC and 30 CRC.

Matched Controls

Eligibility Criteria

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

You may qualify if:

• In order to be eligible to participate in this study, a patient must meet all of the following criteria:
• Patients ≥ 18 years of age with
• mPDAC cohort: Metastatic pancreatic ductal cancer who experienced disease progression or not tolerating fluoropyrimidine-, oxaliplatin- and irinotecan- based regimens or prior treatment with gemcitabine and nab-paclitaxel or are not a candidate for chemotherapy
• mCRC Cohort : Metastatic CRC who experienced disease progression on 5-fluorouracil (5-FU), capecitabine, oxaliplatin and irinotecan as FOLFIRI and/or FOLFOX and/or XELOX and/or XELIRI and/or FOLFOXIRI/FOLFIRINOX or who are not candidates for chemotherapy.
• 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.
• 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.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Pregnant or breast feeding
• Patients who cannot tolerate the placement of a tunneled catheter for 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 therapy (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 \>180mmHg
• Ongoing uncontrolled, serious infection.
• Renal failure requiring dialysis.
• Patients with a life expectancy of less than 30 days.
• 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

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Lakhmir Chawla, M.D.

  ExThera Medical

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Drina Aldana

CONTACT

(925) 839-2060; drina@extheramedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Unblinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study patients will be assigned to receive procedure with the investigational device (ONCObind) and will be matched with site specific controls. 60 with ONCObind procedure and 60 Controlled

Study Record Dates

• First Submitted: October 19, 2024
• First Posted: October 23, 2024
• Study Start (Estimated): January 15, 2027
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share