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NCT07042100
A Study to Test the Safety and Tolerability of SBO-154 in Patients With Advanced Solid Tumors.
Conditions: Advanced Solid Tumors
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 177
Sponsor: Sun Pharma Advanced Research Company Limited
Location: Honorhealth Research Institute Scottsdale Arizona
Summary
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 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.
Source: ClinicalTrials.gov (NCT07042100). StuddyBuddy aggregates publicly available trial information.
