Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06655142
NA

OSCAR II STUDY - The ONCObind CTC Removal Study

Sponsor: ExThera Medical Corporation

View on ClinicalTrials.gov

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.

Official title: Prospective Matched Control Feasibility Study to Determine the Capacity of the Onco-Seraph 100 Microbind® Affinity Blood Filter ( ONCObind Procedure) to Remove Circulating Tumor Cells From the Blood in Patients With Either Metastatic Pancreatic Adenocarcinoma or Metastatic Colorectal Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-10-15

Completion Date

2026-06

Last Updated

2025-07-08

Healthy Volunteers

No

Interventions

DEVICE

ONCObind (Onco-Seraph) 100 Filter

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.

OTHER

Matched Controls

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.