A Study to Test the Safety and Tolerability of SBO-154 in Patients With Advanced Solid Tumors.
Recruiting now · Phase 1
Conditions studied: Advanced Solid Tumors
In brief
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.
Key facts
- Study ID
- NCT07042100
- Run by
- Sun Pharma Advanced Research Company Limited
- People needed
- 177
- Starts
- 2025-08-12
- Expected to finish
- 2030-08-01
- Last updated by the study team
- 2026-07-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Honorhealth Research Institute — Scottsdale, Arizona, United States (enrolling)
- Sarcoma Oncology Research Center — Santa Monica, California, United States (enrolling)
- Yale University - Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
- Hope and Healing Clinical Research LLC — Hinsdale, Illinois, United States (enrolling)
- MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- Scientia Clinical Research — Randwick, New South Wales, Australia (enrolling)
- Sunshine Coast University Private Hospital — Birtinya, Queensland, Australia (enrolling)
- Cancer Research South Australia — Adelaide, South Australia, Australia (enrolling)
- Tata Memorial hospital — Mumbai, Maharashtra, India (enrolling)
- Noble Hospital Pvt. Ltd. — Pune, Maharashtra, India (enrolling)
- All India Institute for Medical Sciences — Delhi, New Delhi, India (enrolling)
- Pacific Medical College and Hospital — Udaipur, Rajasthan, India (enrolling)
- Kainos Super Speciality Hopsital — Rohtak, Haryana, India
- Amrita Institute of Medical Sciences — Ernākulam, Kerala, India
- Sir H.N Reliance Foundation Hospital — Mumbai, Maharashtra, India
- S.P. Medical College and AG of Hospitals — Bikaner, Rajasthan, India
Full record on ClinicalTrials.gov
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