Clinical trialPhase 1Completed
A Phase I Study of SOR-C13 in Patients With Advanced Solid Tumors
- Outcome
- Finished, no results posted
- Phase
- Phase 1
- Status
- Completed
- Study type
- Interventional
- Start
- 29 July 2019
- Expected end
- 20 June 2023
- Enrollment
- 11 participants
- Sites
- 1
- Primary outcomes
- Incidence of adverse events and serious adverse events; Incidence of >= grade 2 adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0; Dose-limiting toxicities; Withdrawals from the study due to treatment-related adverse events will be documented; Change of the treatment regimen such as dose delay and dose reduction over time by dose level due to treatment-related adverse events
- Sponsor
- Other
- Results posted
- No
- Last update
- 18 November 2023
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Brief summary public domain (ClinicalTrials.gov)
This phase I trial studies the side effects and best dose of SOR-C13 in treating patients with solid tumors that have spread to other places in the body (advanced) and does not respond to treatment. Drugs used in chemotherapy, such as SOR-C13, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Detailed description public domain (ClinicalTrials.gov)
PRIMARY OBJECTIVES: I. To define the maximum tolerated doses (MTD) of TRPV6 calcium channel inhibitor SOR-C13 (SOR-C13) in subjects with advanced solid tumor cancers of epithelial origin. II. To define the safety profiles of the treatment. SECONDARY OBJECTIVES: I. To evaluate clinical response signals to the treatment. II. To assess predictive biomarkers (baseline molecular mutation status) and/or resistant pathways by comparing molecular signatures at baseline versus at time of relapse in patients who have achieved objective responses. OUTLINE: This is a dose-escalation study. Patients receive TRPV6 calcium channel inhibitor SOR-C13 intravenously (IV) over 2 hours on days 1, 2, 8, 9, 15, 16, 22, and 23. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.