Sym021 in Combination With Either Sym022 or Sym023 in Patients With Advanced Solid Tumor Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Cancer
- Solid Tumor
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: 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
The study will evaluate safety and efficacy in participant with small cell lung cancer, urothelial cancer and bladder cancer who have developed resistance to prior anti-PD1 or anti-PD-L1 therapy and in patient with cholangiocarcinoma who have received at least 1 line of standard of care therapy and ...
The study will evaluate safety and efficacy in participant with small cell lung cancer, urothelial cancer and bladder cancer who have developed resistance to prior anti-PD1 or anti-PD-L1 therapy and in patient with cholangiocarcinoma who have received at least 1 line of standard of care therapy and have progressed on it. Per 22nd of December 2020 recruitment for small cell lung cancer, urothelial cancer and bladder cancer has temporarily stopped due to strategy considerations. Recruitment for cholangiocarcinoma is still open. Per May 2021 recruitment into the trial is temporarily halted. Symphogen wish to halt recruitment during the first planned interim analysis as the recruitment is faster than expected and therefore many patient could be enrolled before the results of the interim analysis is known. A protocol amendment has been submitted 23rd of April to FDA including changes for the temporarily halt in recruitment during interim analysis.
Tracking Information
- NCT #
- NCT04641871
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Nehal Lakhani, MD START Midwest