A Phase 1, Multicentre, Open-label, Multiple-dose Study to Determine Safety, Tolerability, and Preliminary Efficacy of SBO-154 in Subjects With Advanced Solid Tumors
Sun Pharma Advanced Research Company Limited
Summary
This is a Phase 1 study of SBO-154 in patients with advanced cancers who are unable to tolerate or have not previously responded to standard therapy available in the country. The study involves multiple doses and takes place at several centers.
Description
This study has two parts. In Part 1, the goal to evaluate the safety and tolerability along with the highest dose that can be tolerated, or the dose(s) which can be chosen for further evaluation. In Part 2, the focus is on evaluating the safety of SBO-154 in specific types of advanced cancers.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Willing and able to give written and dated informed consent (or legally acceptable representative/ impartial witness when applicable) and is available for the entire study. 2. Willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions (in the Investigator's opinion), and be accessible for follow-up. 3. Has locally recurrent or metastatic disease (except sarcomas) which has relapsed or progressed following local standard treatment, or for which no standard treatment is available. 4. Has a life expectancy o…
Interventions
- BiologicalDose level (DL)1
Administered IV every 3 weeks
- BiologicalDL2
Administered IV every 3 weeks
- BiologicalDL3
Administered IV every 3 weeks
- BiologicalDL4
Administered IV every 3 weeks
- BiologicalDL5
Administered IV every 3 weeks
Locations (11)
- Honorhealth Research InstituteScottsdale, Arizona
- Sarcoma Oncology Research CenterSanta Monica, California
- Yale University - Yale Cancer CenterNew Haven, Connecticut
- Hope And Healing Cancer Services, LlcHinsdale, Illinois
- MD Anderson Cancer CenterHouston, Texas
- Scientia Clinical ResearchRandwick, New South Wales