Pressure Enabled Intrapancreatic Delivery Of SD-101 With Checkpoint Blockade For Locally Advanced Pancreatic Adenocarcinoma

Study Overview

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

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.

This study will be conducted in 2 phases. In Phase 1, escalating doses of SD-101 will be administered alone via PRVI into the regional vessels of the pancreas containing the locally advanced tumor. The first three patients will part of a safety run-in. Following determination of the recommended MTD or optimal biologic dose (OBD) of SD-101 for PRVI, the study will progress to Phase 1b to assess the safety of concomitant SD-101 and CPI usage, along with preliminary efficacy. Patients in Phase 1b will receive the SD-101 dose selected from Phase 1 together with systemic anti-PD-1, defined as any FDA approved anti-PD-1, checkpoint blockade. SD-101 will be administered over 2 cycles, with 1 dose per cycle and each cycle being about 6 weeks apart.

Locally Advanced Pancreatic Adenocarcinoma

DRUG: SD-101
BIOLOGICAL: anti-PD-1

TS-PERIO-03

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-10-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-07-01
First Submitted that Met QC Criteria 2022-11-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-07-04
First Posted (ACTUAL) 2022-11-07	Results First Posted N/A	Last Verified 2025-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: SD-101 Two doses of SD-101 given over two cycles via pancreatic retrograde venous infusion (PRVI) using the PEDD method of administration.	DRUG: SD-101 SD-101 doses are administered via PRVI using the PEDD method of administration BIOLOGICAL: anti-PD-1 In the Phase 1b, anti-PD-1 will be administered together with SD-101

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: SD-101

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

DRUG: SD-101

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

BIOLOGICAL: anti-PD-1

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

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
Phase 1 - To assess the RECIST v1.1 ORR	As a measure of activity, ORR will be assessed. ORR will be assessed using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.	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.	As a measure of activity, OS will be assessed. The events for the assessment of 12-month OS are death events.	12 months
Phase 1b - To assess preliminary efficacy in terms of RECIST for immune based therapeutics on ORR.	As a measure of activity, iRECIST will be utilized to determine overall response rate (ORR).	12 months
Phase 1b - To assess preliminary efficacy in terms of RECIST 1.1 pancreatic-specific response rate (PRR).	As a measure of activity, RECIST 1.1 will be utilized to determine pancreatic specific response rate.	12 months
Phase 1b - To assess preliminary efficacy in terms of RECIST 1.1 pancreatic-specific progression free survival (PPFS)	As a measure of activity, RECIST 1.1 will be utilized to determine pancreatic specific progression free survival	12 months
Phase 1b - To assess preliminary efficacy in terms of RECIST for immune based therapeutics on duration of response.	As a measure of activity, RECIST 1.1 will be utilized to determine duration of response (DOR)	12 months
Phase 1b - To assess preliminary efficacy in terms of RECIST for immune based therapeutics on clinical benefit ([CR] + [PR] + [SD]).	As a measure of activity, RECIST 1.1 will be utilized to determine clinical benefit (complete response [CR] + partial response [PR] + stable disease [SD]).	12 months
Phase 1b - To assess preliminary efficacy in terms of modified RECIST (mRECIST) for immune based therapeutics	As a measure of activity, mRECIST will be utilized to determine overall response rate (ORR).	12 months
Phase 1b - To assess preliminary efficacy in terms of RECIST 1.1 progression free survival (PFS)	As a measure of activity, RECIST 1.1 will be utilized to determine progression free survival (PFS)	12 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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:

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
Has a QTc interval ≤480 msec
All associated clinically significant (in the judgment of the Investigator) drug-related toxicity from previous cancer therapy must be resolved (to Grade ≤1 or the patient's pretreatment level) prior to study treatment administration (Grade 2 alopecia, grade 2 peripheral neuropathy from prior chemotherapy, and endocrinopathies controlled on replacement therapy are allowed).
Has adequate organ function at screening as evidence by:

Females of childbearing potential must be nonpregnant and nonlactating, or post-menopausal, and have a negative serum human chorionic gonadotropin (hCG) pregnancy test result at screening and prior to the first dose of study intervention.

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
Has active, known, or suspected autoimmune disease or immune-mediated disease. Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment or conditions not expected to recur in the absences of an external trigger are not exclusionary
Is receiving systemic steroid therapy >10 mg of prednisone daily or equivalent or any other immunosuppressive medication at any dose level. Local steroid therapies (e.g., otic, ophthalmic, intra-articular or inhaled medications) are acceptable
Has significant concurrent or intercurrent illness, psychiatric disorder, or alcohol or chemical dependence that would, in the opinion of the Investigator and/or Medical Monitor, compromise their safety or compliance or interfere with interpretation of the study
Lactating women are excluded from study participation
Has previously received SD-101
Medical history of significant hypersensitivity, severe and unresolved immune-mediated reactions, severe infusion-related reactions, or allergic reaction to TLR9 agonists or CPI agents in the judgment of the Investigator
Patients who were enrolled in the Phase 1 portion of the study will not be eligible for enrollment in Phase 1b

Collaborators and Investigators

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