Study of the Safety, Pharmacokinetics and Efficacy of EDO-S101, in Patients With Advanced Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 158
Summary
- Conditions
- Endometrial Cancer
- Ovarian Cancer
- Small Cell Lung Cancer
- Soft Tissue Sarcoma
- Triple -Negative Breast Cancer
- Type
- Interventional
- Phase
- Phase 1Phase 2
- 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
The study consists of 2 phases: Phase 1: Dose Escalation until MAD Phase 2: Evaluation of Toxicity and Response Rate in Selected Solid Tumor Cohorts The study is designed as an open label, Phase 1/2 trial of single agent EDO-S101. The Phase 1 portion of the study is designed to define the MTD by eva...
The study consists of 2 phases: Phase 1: Dose Escalation until MAD Phase 2: Evaluation of Toxicity and Response Rate in Selected Solid Tumor Cohorts The study is designed as an open label, Phase 1/2 trial of single agent EDO-S101. The Phase 1 portion of the study is designed to define the MTD by evaluating toxicities during dose escalation until MAD. The Phase 2 portion of the study is designed to evaluate ORR and SD that persists for at least 4 months of the RP2D.
Tracking Information
- NCT #
- NCT03345485
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Shivaani Kummar, MD Stanford University
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