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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence of dose-limiting toxicities — Twenty-one days from the initiation of the first dose of SBO-154 (3 weeks) Applicable to Part 1 only
Incidence of treatment-related serious adverse events — Throughout the study: from the start of study drug to 30 days post the last dose of study drug.
Incidence of treatment-related adverse events — Throughout the study: from the start of study drug to 30 days post the last dose of study drug.
Trial sites (16)
Facility
City
Region
Status
Honorhealth Research Institute
Scottsdale
Arizona
Recruiting
Sarcoma Oncology Research Center
Santa Monica
California
Recruiting
Yale University - Yale Cancer Center
New Haven
Connecticut
Recruiting
Hope and Healing Clinical Research LLC
Hinsdale
Illinois
Recruiting
MD Anderson Cancer Center
Houston
Texas
Recruiting
Scientia Clinical Research
Randwick
New South Wales
Recruiting
Sunshine Coast University Private Hospital
Birtinya
Queensland
Recruiting
Cancer Research South Australia
Adelaide
South Australia
Recruiting
Kainos Super Speciality Hopsital
Rohtak
Haryana
Not Yet Recruiting
Amrita Institute of Medical Sciences
Ernākulam
Kerala
Not Yet Recruiting
Sir H.N Reliance Foundation Hospital
Mumbai
Maharashtra
Not Yet Recruiting
Tata Memorial hospital
Mumbai
Maharashtra
Recruiting
Noble Hospital Pvt. Ltd.
Pune
Maharashtra
Recruiting
All India Institute for Medical Sciences
Delhi
New Delhi
Recruiting
S.P. Medical College and AG of Hospitals
Bikaner
Rajasthan
Not Yet Recruiting
Pacific Medical College and Hospital
Udaipur
Rajasthan
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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