Safety and tolerability of SBO-154 for people 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

This trial tests whether the experimental drug SBO-154 is safe and tolerable for adults with advanced solid tumors who have not responded to or cannot take standard treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 177 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sun Pharma Advanced Research Company Limited (Industry-sponsored)
• Locations: 11 sites (Scottsdale, Arizona and 10 other locations)
• Trial ID: NCT07042100 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with locally recurrent or metastatic solid tumors (excluding sarcomas) that have relapsed or progressed after standard treatment, who can give informed consent and have an expected life expectancy of at least three months, are ideal candidates.

Not a fit: Patients with uncontrolled infections requiring IV antibiotics, significant organ dysfunction, recent major surgery within four weeks, active significant substance abuse, or those with sarcomas are unlikely to benefit or may be ineligible.

Why it matters

Potential benefit: If successful, SBO-154 could provide a new treatment option for people with advanced solid tumors who have limited or no standard therapies available.

How similar studies have performed: Dose-escalation Phase 1 trials are the standard first step for new cancer drugs and similar early-phase trials have sometimes identified safe doses and early signs of activity, though results vary and SBO-154 is being tested here primarily for safety.

Eligibility criteria

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 this trial is running

Scottsdale, Arizona and 10 other locations

• 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 (Not_yet_recruiting)
• Hope And Healing Cancer Services, Llc — Hinsdale, Illinois, United States (Recruiting)
• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
• Scientia Clinical Research — Randwick, New South Wales, Australia (Recruiting)
• Sunshine Coast University Private Hospital — Birtinya, Queensland, Australia (Recruiting)
• Cancer Research South Australia — Adelaide, South Australia, Australia (Recruiting)
• Tata Memorial hospital — Mumbai, Maharashtra, India (Not_yet_recruiting)
• Noble Hospital Pvt. Ltd. — Pune, Maharashtra, India (Recruiting)
• All India Institute for Medical Sciences — Delhi, New Delhi, India (Recruiting)

Study contacts

• Study coordinator: Dr. Sandeep Inamdar

Conditions Advanced Solid Tumors