Safety and tolerability of SBO-154 for people with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, multi-center trial enrolls adults with locally recurrent or metastatic solid tumors who have exhausted or cannot receive standard therapies. Part 1 uses dose-escalation across multiple dose levels (DL1–DL5) to identify the highest tolerated dose(s) and observe dose-limiting toxicities. Part 2 continues to monitor safety of the selected dose(s) in specific advanced cancer types. Safety monitoring includes regular clinical assessments and laboratory testing to track adverse events and tolerability.

Why it matters

Who can join: the full rules

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 of ≥3 months.

Exclusion Criteria:

1. Any major surgery, as determined by the Investigator, within 4 weeks of SBO-154 administration.
2. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination.
3. Known or suspected history of significant drug abuse as judged by the Investigator.
4. Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
5. Known or suspected history of excessive intake of alcohol in the 12 months prior to study entry.
6. 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).
7. 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.
8. Received an investigational agent within 30 days or 5 half-lives- whichever is shorter prior to SBO-154 administration.

Where it's running

• Honorhealth Research Institute
  Scottsdale, Arizona, United States Recruiting
• Sarcoma Oncology Research Center
  Santa Monica, California, United States Recruiting
• Yale University - Yale Cancer Center
  New Haven, Connecticut, United States Recruiting
• Hope and Healing Clinical Research LLC
  Hinsdale, Illinois, United States Recruiting
• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• Scientia Clinical Research
  Randwick, New South Wales, Australia Recruiting

Study contacts

• Study coordinator: Dr. Sandeep Inamdar
• Email: clinical.trials@sparcmail.com
• Phone: 91-22-66455645

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.