Study of SRF388 in Patients With Advanced Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 92
Summary
- Conditions
- Advanced Solid Tumor
- Clear Cell Renal Cell Carcinoma
- Hepatocellular Carcinoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a Phase 1/1b, open-label, first-in-human (FIH), dose-escalation and expansion study of SRF388, a monoclonal antibody targeting IL-27, as a monotherapy and in combination in patients with solid tumors that will be conducted in 3 parts: Part A: SRF388 monotherapy dose-escalation portion of the...
This is a Phase 1/1b, open-label, first-in-human (FIH), dose-escalation and expansion study of SRF388, a monoclonal antibody targeting IL-27, as a monotherapy and in combination in patients with solid tumors that will be conducted in 3 parts: Part A: SRF388 monotherapy dose-escalation portion of the study will evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of SRF388 as monotherapy in patients with advanced solid tumors. Part B: SRF388 monotherapy expansion cohorts will evaluate the safety, efficacy, tolerability, PK, and pharmacodynamics of SRF388 monotherapy in patients with advanced or metastatic ccRCC (any clear cell component in the histologic definition) and advanced or metastatic HCC in indication specific cohorts. Part C will evaluate the safety, preliminary efficacy, tolerability, and PK of SRF388 in combination with pembrolizumab in patients with advanced RCC or HCC.
Tracking Information
- NCT #
- NCT04374877
- Collaborators
- Not Provided
- Investigators
- Study Chair: Lauren Harshman, MD Surface Oncology
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