This study is an open-label, phase 1/1b study of the pressure-enabled hepatic artery infusion
of SD-101, a TLR 9 agonist, alone or in combination with intravenous checkpoint blockade in
adults with metastatic uveal melanoma.
In the Sentinel Cohort, patients will receive 2 SD-101 infusions (2 weeks apart) with
assessments for toxicity prior to escalating from the first dose level (0.5 mg) to the second
dose level (2 mg). In the absence of dose-limiting toxicities (DLTs), each patient will be
eligible to transition into Cohort A.
In Cohorts A-C and Phase 1b, patients will receive 2 cycles of SD-101. Each cycle consists of
3 consecutive weekly infusions. Escalating doses of SD-101 will be administered alone (Cohort
A), together with nivolumab (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 for PEDD/HAI and
which checkpoint inhibitor (CPI) regimen(s) are tolerated, the study will progress to Phase
1b. Patients in Phase 1b will receive the SD-101 dose selected from Phase 1 in the presence
of systemic single- or double-agent checkpoint blockade. The choice of single- or
double-agent CPI therapy together with SD-101 for Phase 1b will consider safety data in
addition to response rates from Cohorts B and C in Phase 1.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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