Blood Purification Procedure for Pancreatic Cancer

Overseen By Drina Aldana

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ExThera Medical Corporation

Disqualifiers: Pregnancy, Heparin allergy, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 96

120 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants should not be in another investigational drug study or have received investigational treatment within 14 days before starting this trial.

How does the ONCObind (Onco-Seraph) 100 Filter treatment for pancreatic cancer differ from other treatments?

The ONCObind (Onco-Seraph) 100 Filter treatment is unique because it involves a blood purification procedure, which is different from traditional treatments like chemotherapy or surgery. This approach may offer a novel way to manage pancreatic cancer by potentially removing harmful substances from the blood, although specific details about its mechanism and effectiveness are not provided in the available research. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Lakhmir Chawla, M.D.

Principal Investigator

ExThera Medical

Eligibility Criteria

Adults over 18 with advanced pancreatic cancer or colorectal cancer that's not responding to treatment. They must have a certain number of tumor cells in their blood and be able to perform daily activities with minimal assistance (ECOG PS ≤2).

Inclusion Criteria

Patient or legally authorized representative must be willing and able to provide a signed informed consent

Patients must have a CTC concentration of at least 5 cells/mL

Patients must be of non-childbearing potential or using a medically acceptable contraceptive regimen

Exclusion Criteria

Pregnant or breast feeding

Patients who cannot tolerate the placement of a tunneled catheter for vascular access

Patients with a history of heparin induced thrombocytopenia (HIT)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Phase

Participants undergo the ONCObind procedure up to 3-5 times in the first week, followed by 1-3 treatments through week 4

4 weeks

Up to 8 treatments over the first 28 days

Procedure Follow-up Phase

Participants receive follow-up visits weekly through day 28, then monthly through day 60

8 weeks

Weekly visits through day 28, monthly visits through day 60

Long-term Follow-up

Participants are monitored for safety and effectiveness, with survival follow-up assessed at 60, 120, 180, and 210 days

210 days

Survival follow-up at 60, 120, 180, and 210 days

Treatment Details

Interventions

• ONCObind (Onco-Seraph) 100 Filter

Trial Overview The trial is testing ONCObind, a new procedure for filtering out tumor cells from the blood. Participants will be divided into two groups based on their type of cancer, but there won't be any comparison group receiving a placebo.

Participant Groups

Group I: ONCObind (Onco-Seraph) 100 Filter is a single use Experimental Treatment 1 Intervention

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.

Group II: Matched Controls Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

ExThera Medical Corporation

Lead Sponsor

Trials

8

Recruited

540+

References

1. United States pubmed.ncbi.nlm.nih.gov

Identification of human complement factor B as a novel biomarker candidate for pancreatic ductal adenocarcinoma. [2015]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Pilot scale purification of human monoclonal IgM (COU-1) for clinical trials. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Plasma protein profiling in a stage defined pancreatic cancer cohort - Implications for early diagnosis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Combined circulating tumor DNA and protein biomarker-based liquid biopsy for the earlier detection of pancreatic cancers. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Monoclonal antibody CO17-1A and leukapheresis in immunotherapy of pancreatic cancer. [2006]