SD-101

DRUG12 trials

Sponsors

Dynavax Technologies Corporation, Robert Lowsky, Merck Sharp & Dohme LLC, David Oh, University of California, Davis

Conditions

Advanced Solid TumorsB-cell LymphomaChronic Hepatitis CExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueHealthyHepatocellular CarcinomaHodgkin DiseaseIntrahepatic Cholangiocarcinoma

Phase 1

Safety, Pharmacokinetics, and Pharmacodynamics of SD-101 in Healthy Normal Males

CompletedNCT00599001

Dynavax Technologies CorporationHealthy

Start: 2008-01-31End: 2008-03-31Updated: 2019-04-16

Safety Study of SD-101 (a Novel C Type Toll-like Receptor 9 (TLR9) Agonist) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection

CompletedNCT00823862

Dynavax Technologies CorporationChronic Hepatitis C

Start: 2008-10-31End: 2010-02-28Updated: 2019-04-16

Immunostimulatory CpG SD-101 + RT in Recurrent/Progressive Lymphoma After Allogeneic Hematopoietic Cell Transplantation (HCT)

TerminatedNCT01745354

Robert LowskyHodgkin Disease, Lymphoma, Non-Hodgkin

Start: 2012-08-31End: 2014-11-30Updated: 2016-11-18

A Phase I/II Study of Intratumoral Injection of SD-101

CompletedNCT02254772

Robert LowskyExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Grade 1 Follicular Lymphoma +4

Start: 2014-09-30End: 2017-01-26Updated: 2019-11-27

Study of SD-101 in Combination With Localized Low-dose Radiation in Patients With Untreated Low-grade B-cell Lymphoma

TerminatedNCT02266147

Dynavax Technologies CorporationB-cell Lymphoma

Start: 2014-10-31End: 2017-04-30Updated: 2020-09-04

Dose Evaluation of MK-1966 in Combination With SD-101 in Participants With Advanced Malignancies (MK-1966-001)

TerminatedNCT02731742

Merck Sharp & Dohme LLCNeoplasms, Advanced

Start: 2016-06-22End: 2018-01-08Updated: 2019-02-04

UCDCC#271: Phase I/II Trial of Epacadostat, Intralesional SD101, Radiotherapy in Patients With Lymphoma

CompletedNCT03322384

University of California, DavisAdvanced Solid Tumors, Lymphoma

Start: 2018-01-17End: 2020-04-08Updated: 2022-02-01

Intrahepatic Delivery of SD-101 by Pressure-Enabled Regional Immuno-oncology (PERIO), With Checkpoint Blockade in Adults With Metastatic Uveal Melanoma

TerminatedNCT04935229

TriSalus Life Sciences, Inc.Metastatic Uveal Melanoma in the Liver

Start: 2021-08-02End: 2024-07-17Updated: 2025-10-22

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

TerminatedNCT05220722

TriSalus Life Sciences, Inc.Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma

Start: 2022-03-02End: 2024-07-31Updated: 2025-10-23

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

Active, not recruitingNCT05607953

TriSalus Life Sciences, Inc.Locally Advanced Pancreatic Adenocarcinoma

Start: 2023-03-01End: 2027-10-31Target: 60Updated: 2025-07-04

Cryoablation and Arterial Infusion of SD-101 in Combination with Durvalumab and Tremelimumab

RecruitingNCT06710223

University of California, San DiegoHepatocellular Carcinoma

Start: 2025-01-03End: 2027-06-30Target: 20Updated: 2025-02-11

Phase 2

Pembrolizumab +/- SD-101 in Hormone-Naïve Oligometastatic Prostate Cancer With RT and iADT

CompletedNCT03007732

David OhProstatic Neoplasms

Start: 2017-05-17End: 2025-03-31Updated: 2025-12-05

Related Papers

PERIO-02: Phase 1b pressure enabled regional immuno-oncology trial of nelitolimod (SD-101), a class C TLR9 agonist, delivered via hepatic artery infusion +/- checkpoint inhibition in intrahepatic cholangiocarcinoma and hepatocellular carcinoma.

Journal of Clinical Oncology2024-06-014 citations

Abstract 4988: Responders to combination radiation and PD-1 blockade demonstrate reduced myeloid immunosuppression and enhanced interferon signaling in oligometastatic prostate cancer patients

Cancer Research2024-03-22

1534 Clinical activity of SD-101 with immune checkpoint inhibition (ICI) in metastatic uveal melanoma liver metastasis (MUM-LM) from the PERIO-01 Phase 1 trial

2023-10-314 citations

647 PERIO-03: Pressure enabled intrapancreatic delivery of SD-101 with checkpoint blockade for locally advanced pancreatic adenocarcinoma – Initial safety and feasibility experience

Regular and Young Investigator Award Abstracts2023-10-313 citations

Safety and early biologic effects of phase 1 PERIO-01 trial of pressure-enabled drug delivery (PEDD) of TLR9 agonist SD-101 and immune checkpoint inhibition (ICI) in uveal melanoma metastatic to the liver (MUM).

Journal of Clinical Oncology2023-06-018 citations

Abstract 5881: PERIO-01: Initial safety experience and immunologic effects of a Class C TLR9 agonist using pressure- enabled drug delivery in a phase 1 trial of hepatic arterial infusion of SD-101 +/- checkpoint inhibition in metastatic uveal melanoma

Cancer Research2023-04-042 citations

1165 Impact of SD-101, a toll-like receptor 9 class C (TLR9C), agonist on myeloid derived suppressor cells

Regular and Young Investigator Award Abstracts2022-11-012 citations

Activity of a Sting and a TLR9 Agonist As an “in Situ Therapeutic Vaccination” Against Lymphomas

Blood2016-12-021 citations

Regulatory T Cells Are Depleted in Low-Grade Lymphoma By the Combination of Local Low-Dose Radiation Followed By Intratumoral CpG-ODN

Blood2015-12-03

Phase I/II study of intratumoral injection of SD-101, an immunostimulatory CpG, and intratumoral injection of ipillumumab, an anti-CTLA-4 monoclonal antibody, in combination with local radiation in low-grade B-cell lymphomas.

Journal of Clinical Oncology2015-05-207 citations

Dose-Escalated, Intratumoral TLR9 Agonist and Low-Dose Radiation Induce Abscopal Effects in Follicular Lymphoma

Blood2014-12-0612 citations