SD-101 and BMS-986178 in Treating Patients With Advanced or Metastatic Solid Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 27
Summary
- Conditions
- Advanced Malignant Solid Neoplasm
- Extracranial Solid Neoplasm
- Metastatic Malignant Solid Neoplasm
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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: To evaluate the efficacy of treatment...
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: To evaluate the efficacy of treatment with intratumoral SD 101 in combination with intratumoral and intravenous BMS 986178 in patients with advanced solid tumors. 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.
Tracking Information
- NCT #
- NCT03831295
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Principal Investigator: Saad A Khan Stanford Cancer Institute Palo Alto
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