Study of SRF617 in Patients With Advanced Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 56
Summary
- Conditions
- Advanced Solid Tumor
- 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
A Phase 1, open-label, first-in-human, SRF617 monotherapy and combination therapy dose escalation, safety, and tumor biopsy expansion study in patients with advanced solid tumors. The monotherapy dose escalation portion of the study will evaluate the safety, tolerability, pharmacokinetics (PK), phar...
A Phase 1, open-label, first-in-human, SRF617 monotherapy and combination therapy dose escalation, safety, and tumor biopsy expansion study in patients with advanced solid tumors. The monotherapy dose escalation portion of the study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of SRF617 as monotherapy in patients with advanced solid tumors. The monotherapy tumor biopsy expansion portion of the study will further evaluate the safety and intratumoral pharmacodynamics of SRF617 monotherapy. The combination therapy dose escalation portion of the study will evaluate the safety, tolerability, PK, and preliminary efficacy of SRF617 in combination with gemcitabine + albumin-bound paclitaxel, or SRF617 in combination with pembrolizumab, in patients with locally advanced or metastatic solid tumors. The combination therapy dose escalation portion of the study will evaluate the safety, tolerability, PK, and preliminary efficacy of SRF617 in combination with gemcitabine + albumin-bound paclitaxel, or SRF617 in combination with pembrolizumab, in patients with locally advanced or metastatic solid tumors. The combination expansion will evaluate SRF617 in combination with pembrolizumab in PD-1 naive patients with HER2 negative gastric or gastroesophageal junction (GEJ) adenocarcinoma and SRF617 in combination with gemcitabine + albumin-bound paclitaxel in patients with advanced pancreatic ductal adenocarcinoma (PDAC).
Tracking Information
- NCT #
- NCT04336098
- Collaborators
- Not Provided
- Investigators
- Study Chair: Alison O'Neill, MD Surface Oncology
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