Active — Not RecruitingPhase 1

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

United States60 participantsStarted 2023-03-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. Platelet count \>80,000/μL
✓. Hemoglobin ≥8.0 g/dL

Exclusion criteria

✕. 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.

What they're measuring

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

Timeframe: 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)

Timeframe: 12 months

Trial details

NCT IDNCT05607953

SponsorTriSalus Life Sciences, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-09

View on ClinicalTrials.gov More Locally Advanced Pancreatic Adenocarcinoma trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. Platelet count \>80,000/μL
✓. Hemoglobin ≥8.0 g/dL

Exclusion criteria

✕. 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.

What they're measuring

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

Timeframe: 12 months