Locally Advanced Pancreatic AdenocarcinomaPhase 1NCT05607953
Pressure Enabled Intrapancreatic Delivery of SD-101 With Checkpoint Blockade for Locally Advanced Pancreatic Adenocarcinoma
A Phase 1 study testing SD-101 and anti-PD-1 in people with Locally Advanced Pancreatic Adenocarcinoma, run by TriSalus Life Sciences, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Pancreatic Adenocarcinoma
- What is being tested?
- SD-101 and anti-PD-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to Oct 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 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:
- Platelet count >80,000/μL
- Hemoglobin ≥8.0 g/dL
- White blood cell (WBC) count >2,000/μL
- Serum creatinine ≤2.0 mg/dL unless the measured creatinine clearance is ≥30 mL/min calculated by Cockcroft-Gault formula.
- Total and direct bilirubin ≤2.0 × the upper limit of normal (ULN) and alkaline phosphatase ≤5 × ULN. For patients with documented Gilbert's disease, total bilirubin up to 3.0 mg/dL is allowed.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 × ULN
- Amylase and lipase ≤3 × ULN
- Prothrombin time/International Normalized Ratio (INR) or activated partial thromboplastin time (aPTT) test results at screening ≤1.5 × ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose for at least 4 weeks prior to the first dose of study intervention) Note: Laboratory tests with exclusionary results judged by the Investigator as not compatible with the patient's clinical status may be repeated once for eligibility purposes.
- 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.
- Females of childbearing potential must agree to abstain from sexual activity with nonsterilized male partners, or if sexually active with a nonsterilized male partner must agree to use highly effective methods of contraception from screening, throughout the study and agree to continue using such precautions for 100 days after the final dose of study intervention.
- Nonsterilized males who are sexually active with a female of childbearing potential must agree to use effective methods of contraception and avoid sperm donation from Day 1 throughout the study and for 30 days after the final dose of study intervention.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1/1b Pressure Enabled Regional Immuno-Oncology Study of Pancreatic Retrograde Venous Infusion of SD-101 Alone and With Checkpoint Blockade for Locally Advanced Pancreatic Ductal 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.
Read the detailed description
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.
- Being tested
- SD-101, anti-PD-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SD-101Drug
SD-101 doses are administered via PRVI using the PEDD method of administration
anti-PD-1Biological
In the Phase 1b, anti-PD-1 will be administered together with SD-101
| Study group | Role | What they receive |
|---|---|---|
| SD-101 | Experimental | Two doses of SD-101 given over two cycles via pancreatic retrograde venous infusion (PRVI) using the PEDD method of administration. Receives: Drug: SD-101; Biological: anti-PD-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 12 months
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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]).
Measured: 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).
Measured: 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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start1 Mar 2023
- Primary completionSep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TriSalus Life Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607953
- Sponsor's protocol ID
- TS-PERIO-03
- Status last verified
- Jul 2025
- First submitted
- 19 Oct 2022
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b Pressure Enabled Regional Immuno-Oncology Study of Pancreatic Retrograde Venous Infusion of SD-101 Alone and With Checkpoint Blockade for Locally Advanced Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05607953
- Acronym / sponsor ID
- TS-PERIO-03
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- TriSalus Life Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| SD-101 | Experimental | Drug: SD-101, Biological: anti-PD-1Two doses of SD-101 given over two cycles via pancreatic retrograde venous infusion (PRVI) using the PEDD method of administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SD-101SD-101 doses are administered via PRVI using the PEDD method of administration | Drug | SD-101 |
| anti-PD-1In the Phase 1b, anti-PD-1 will be administered together with SD-101 | Biological | SD-101 |
Primary outcome
Phase 1 - To determine the maximum tolerated dose (MTD) or optimal biologic dose (OBD) of SD-101 administered alone via PRVI.
Time frame: 12 months
As a measure of safety, adverse events will be graded according to CTCAE v5.0
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)
Time frame: 12 months
A standard 3+3 dose-escalation design will be employed to determine the MTD or optimal biologic dose.
9 secondary outcomes
Phase 1 - To assess the RECIST v1.1 ORR
Time frame: 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.
Time frame: 12 months
Phase 1b - To assess preliminary efficacy in terms of RECIST for immune based therapeutics on ORR.
Time frame: 12 months
Phase 1b - To assess preliminary efficacy in terms of RECIST 1.1 pancreatic-specific response rate (PRR).
Time frame: 12 months
Phase 1b - To assess preliminary efficacy in terms of RECIST 1.1 pancreatic-specific progression free survival (PPFS)
Time frame: 12 months
Phase 1b - To assess preliminary efficacy in terms of RECIST for immune based therapeutics on duration of response.
Time frame: 12 months
Phase 1b - To assess preliminary efficacy in terms of RECIST for immune based therapeutics on clinical benefit ([CR] + [PR] + [SD]).
Time frame: 12 months
Phase 1b - To assess preliminary efficacy in terms of modified RECIST (mRECIST) for immune based therapeutics
Time frame: 12 months
Phase 1b - To assess preliminary efficacy in terms of RECIST 1.1 progression free survival (PFS)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SD-101 and anti-PD-1 in people with Locally Advanced Pancreatic Adenocarcinoma, run by TriSalus Life Sciences, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 - To determine the maximum tolerated dose (MTD) or optimal biologic dose (OBD) of SD-101 administered alone via PRVI. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.