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Spots Global Cancer Trial Database for Pressure Enabled Delivery of SD-101 With Checkpoint Blockade for Primary Liver Tumors

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Trial Identification

Brief Title: Pressure Enabled Delivery of SD-101 With Checkpoint Blockade for Primary Liver Tumors

Official Title: A Phase 1b/2 Pressure Enabled Regional Immuno-Oncology Study of Hepatic Arterial Infusion of SD-101 With Systemic Checkpoint Blockade for Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma

Study ID: NCT05220722

Study Description

Brief Summary: This is an Open-label, Phase 1b/2 Study of the Pressure-Enabled Hepatic Artery Infusion (HAI) of SD-101, a TLR9 agonist, Alone or in Combination with Intravenous Checkpoint Blockade in Adults with Hepatocellular Carcinoma (HCC) and Intrahepatic Cholangiocarcinoma (ICC).

Detailed Description: All patients will receive 2 cycles of SD-101. Each cycle consists of 3 consecutive weekly infusions and Cycles 1 and 2 are separated by one month. Escalating doses of SD-101 will be administered alone (Cohort A), together with pembrolizumab (Cohort B), and together with combined ipilimumab and nivolumab (Cohort C). Cohort B will begin dosing at the minimum anticipated biological effect level (MABEL (2mg SD-101)). Cohort C will begin one dose level below the MTD or optimal dose from Cohort B to optimize safety when adding CPI to SD-101. Following determination of the recommended MTD or optimal dose of SD-101 and which checkpoint inhibitor (CPI) regimen(s) are tolerated, the study will progress to Phase 2. Patients in Phase 2 will receive the SD-101 dose selected from Phase 1b together with systemic single- or double-agent checkpoint blockade. The choice of single- or double-agent CPI therapy together with SD-101 for Phase 2 will consider safety data in addition to response rates from Cohorts B and C in Phase 1b.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Colorado, Aurora, Colorado, United States

Columbia University, New York, New York, United States

Rhode Island Hospital, Providence, Rhode Island, United States

MD Anderson Cancer Center, Houston, Texas, United States

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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