Clinical Trials Directory

Trials / Completed

CompletedNCT03831295

SD-101 and BMS-986178 in Treating Patients With Advanced or Metastatic Solid Malignancies

Intratumoral Injection of SD-101, an Immunostimulatory CpG Oligonucleotide, in Combination With BMS- 986178, an OX40 Agonist Antibody, in Advanced Solid Malignancies [CA012-014]

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
12 (actual)
Sponsor
Ronald Levy · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase I trial studies the side effects of intratumoral injection of SD-101 and BMS-986178 in treating patients with solid malignancies that have spread to other places in the body. The TLR9 agonist SD-101 may stimulate the immune system in different ways and stop cancer cells from growing. BMS-986178 is a monoclonal anti-OX40 antibody that enhances the activation of T cells, immune cells that are important for fighting tumors. Giving TLR9 agonist SD-101 together with anti-OX40 antibody BMS-986178 may work better in treating patients with advanced solid tumors.

Detailed description

PRIMARY OBJECTIVES: I. To determine the safety and tolerability of intratumoral TLR9 agonist SD-101 (SD-101) in combination with intratumoral and intravenous anti-OX40 antibody BMS 986178 (BMS-986178) in patients with advanced solid tumors. SECONDARY OBJECTIVES: 1. To evaluate the efficacy of treatment with intratumoral SD 101 in combination with intratumoral and intravenous BMS 986178 in patients with advanced solid tumors. 2. To evaluate changes in pharmacodynamic endpoints in serial tumor biopsies from I TUMOR treated and untreated sites of disease. OUTLINE: SAFETY COHORT: Patients receive TLR9 agonist SD-101 intratumorally (IT) on days 1, 8 and 15. Patients also receive anti-OX40 antibody BMS 986178 IT on days 8 and 15, and intravenously (IV) over 30 minutes on days 8, 29 and 58. EXPANSION COHORT: Patients receive TLR9 agonist SD-101 IT on days 1, 8 and 15. Patients also receive anti-OX40 antibody BMS 986178 IT on days 1, 8 and 15, and IV over 30 minutes on days 1, 29 and 58. After completion of study treatment, patients are followed up every 3-6 months.

Conditions

Interventions

TypeNameDescription
BIOLOGICALAnti-OX40 Antibody BMS 986178Given IT or IV
DRUGTLR9 Agonist SD-101Given IT

Timeline

Start date
2019-03-13
Primary completion
2021-10-04
Completion
2021-10-04
First posted
2019-02-05
Last updated
2023-11-22

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03831295. Inclusion in this directory is not an endorsement.