Pressure Enabled Intrapancreatic Delivery of SD-101 With Checkpoint Blockade for Locally Advanced Pancreatic Adenocarcinoma

NCT05607953 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: TS-PERIO-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open-label, phase 1/1b study of the pressure-enabled intrapancreatic infusion of SD-101, a TLR 9 agonist, alone or in combination with intravenous checkpoint blockade in adults with locally advanced pancreatic cancer.

Conditions

Locally Advanced Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Phase 1 - To determine the maximum tolerated dose (MTD) or optimal biologic dose (OBD) of SD-101 administered alone via PRVI.

  As a measure of safety, adverse events will be graded according to CTCAE v5.0

  12 months

• Phase 1b - To determine the safety of SD-101 administered via PRVI in combination with anti-PD-1 and to assess the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 disease control rate (DCR)

  A standard 3+3 dose-escalation design will be employed to determine the MTD or optimal biologic dose.

  12 months

Secondary Outcomes (9)

• Phase 1 - To assess the RECIST v1.1 ORR

  12 months

• Phase 1b - To assess the 12-month overall survival (OS) of PRVI of SD-101 in combination with intravenous (IV) immunological checkpoint blockade.

  12 months

• Phase 1b - To assess preliminary efficacy in terms of RECIST for immune based therapeutics on ORR.

  12 months

• Phase 1b - To assess preliminary efficacy in terms of RECIST 1.1 pancreatic-specific response rate (PRR).

  12 months

• Phase 1b - To assess preliminary efficacy in terms of RECIST 1.1 pancreatic-specific progression free survival (PPFS)

  12 months

Study Arms (1)

SD-101

EXPERIMENTAL

Two doses of SD-101 given over two cycles via pancreatic retrograde venous infusion (PRVI) using the PEDD method of administration.

Drug: SD-101; Biological: anti-PD-1

Interventions

SD-101 DRUG

SD-101 doses are administered via PRVI using the PEDD method of administration

SD-101

anti-PD-1 BIOLOGICAL

In the Phase 1b, anti-PD-1 will be administered together with SD-101

SD-101

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 histologically or cytologically confirmed evaluable or measurable locally advanced unresectable PDAC, or previously confirmed disease in the absence of a documented complete pathologic response.
• Performance status score of 0 or 1 on the ECOG PS scale (scores range from 0 to 5, with higher numbers reflecting greater disability)
• Suitable venous anatomy on a standard portal venous phase imaging as defined by absence of portal, splenic, or superior mesenteric vein complete occlusion Note: As long as there is not complete occlusion and the Interventional Radiologist confirms that the target vein can be accessed, patients may be suitable for enrollment. All 3 veins do not have to be patent for eligibility.
• Having received standard of care chemoradiation therapy or a systemic chemotherapy regimen without a complete radiographic response. Standard of care chemotherapy includes gemcitabine + nab-paclitaxel, or FOLFIRINOX; for others discuss with medical monitor. Radiation with or without concurrent chemotherapy is also acceptable as a standard of care regimen
• Able to understand the study and provide written informed consent prior to any study procedures
• Has not received prior cytotoxic chemotherapy or targeted therapy within 14 days, or external radiation therapy within 4 weeks prior to screening
• Low-burden, asymptomatic metastatic disease permitted if:
• Metastatic disease poses no imminent threat to the patient
• Patient is otherwise asymptomatic with respect to metastases
• Metastases are limited to liver, lung, and/or bone
• No single lesion greater than 5 cm
• Less than 5 metastatic lesions total
• No brain or peritoneal metastases Pancreatic disease must be the dominant determinant of the patient's prognosis and clinical course
• Has no prior history of or other concurrent malignancy unless the malignancy is clinically insignificant, no ongoing treatment is required, and the patient is clinically stable
• Has a life expectancy of \>3 months at screening as estimated by the Investigator

You may not qualify if:

• Main portal, superior mesenteric vein, or splenic vein thrombosis with complete occlusion
• Severe portal hypertension, as evidenced by gastrointestinal (GI) bleeding, thrombocytopenia with splenomegaly
• Chronic pancreatitis
• Active autoimmune disease or history of IgG4 related pancreatitis
• Conversion to local resectability following prior treatment
• Has received chemotherapy or an investigational agent within 14 days (or 5 half-lives, whichever is shorter) before screening
• Has active, untreated brain metastasis
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
• Has main portal vein thrombosis, or severe portal hypertension as defined by a history of variceal hemorrhage or active ascites accumulation refractory to medical management
• Has Child-Pugh Class B or C cirrhosis.
• Has experienced a Grade 3 or higher immune-related AE from prior CPI therapy
• Is unable to be temporarily removed from chronic anticoagulation therapy
• Has a history of bleeding disorder
• Has active coronavirus disease 2019 (COVID-19), other severe infection, including a liver infection or acute pancreatitis, within 2 weeks before the first dose of study drug, or uncontrolled human immunodeficiency virus (HIV) infection at screening
• Has had bacterial pneumonia within 8 weeks of first dose of study drug

Sponsors & Collaborators

• TriSalus Life Sciences, Inc.: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

spartalizumab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1: Two doses of SD-101 (given over two 52-day cycles) in dose-escalation fashion (0.5mg, 2mg, 4mg, 8mg-optional) via pancreatic retrograde infusion using pressure enabled drug delivery with the TriSalus Infusion System device. Phase 1b: Two doses of SD-101 (given over two 52-day cycles) at the maximum tolerated dose or optimal biologic dose defined in Phase 1b via pancreatic retrograde infusion using pressure enabled drug delivery with the TriSalus Infusion System device will be administered with systemic CPI.

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: November 7, 2022
• Study Start: March 1, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

US (1)