ORIN1001 in Patients with Advanced Solid Tumors and Relapsed Refractory Metastatic Breast Cancer
NCT03950570 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 58
Last updated 2024-12-31
Summary
This study evaluates the anti-tumor effects of ORIN 1001 in patients with advanced solid tumors or relapsed refractory metastatic breast cancer (patients with progressive disease after receiving at least two lines of therapy in the advanced setting).
Conditions
- Advanced Solid Tumor
- Metastatic Breast Cancer
Interventions
- DRUG
-
In patients with relapsed. metastatic breast cancer, ORIN1001 will be administered in combination with Abraxane administered by intravenous infusion.
- DRUG
-
ORIN1001
ORIN1001 will be administered as a table as a monotherapy in the dose escalation phase in patients with advanced solid tumors or in combination with Abraxane in patients with relapse, refractory breast cancer
Sponsors & Collaborators
-
Orinove, Inc.
lead INDUSTRY
Principal Investigators
-
Mothaffar F Rimawi, MD · Baylor College of Medicine
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-05-25
- Primary Completion
- 2023-01-30
- Completion
- 2023-01-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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