NCT07042100 · Sun Pharma Advanced Research Company Limited
A Study to Test the Safety and Tolerability of SBO-154 in Patients With Advanced Solid Tumors.
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
- Scottsdale, Arizona
- Santa Monica, California
- New Haven, Connecticut
- Hinsdale, Illinois
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 3, 2026 · Source of record for eligibility and locations