A Study to Test the Safety and Tolerability of SBO-154 in Patients With Advanced Solid Tumors.
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
177 participants
Aug 12, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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.
- 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.
- 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.
- Has a life expectancy of ≥3 months.
Exclusion Criteria8
- Any major surgery, as determined by the Investigator, within 4 weeks of SBO-154 administration.
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination.
- Known or suspected history of significant drug abuse as judged by the Investigator.
- Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
- Known or suspected history of excessive intake of alcohol in the 12 months prior to study entry.
- Positive exclusion tests: urine pregnancy tests (if applicable), serology tests positive for HIV, HCV, HBsAg (unless they are considered subjects with resolved Hepatitis B and C infection).
- History of any relevant allergy/ hypersensitivity including known immediate or delayed hypersensitivity reaction or idiosyncrasy to biological agents or drug chemically related to SBO-154 or its excipients.
- Received an investigational agent within 30 days or 5 half-lives- whichever is shorter prior to SBO-154 administration.
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Interventions
Administered IV every 3 weeks
Administered IV every 3 weeks
Administered IV every 3 weeks
Administered IV every 3 weeks
Administered IV every 3 weeks
Locations(11)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07042100