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Recruiting Phase 1 NCT07042100

A Study to Test the Safety and Tolerability of SBO-154 in Patients With Advanced Solid Tumors.

Phase 1 – testing safety in a small group of people
Conditions: Advanced Solid Tumors

Sponsor: Sun Pharma Advanced Research Company Limited

trial.available_in: БГ
Overview
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.
Description
This study has two parts. In Part 1, the goal to evaluate the safety and tolerability along with the highest dose that can be tolerated, or the dose(s) which can be chosen for further evaluation. In Part 2, the focus is on evaluating the safety of SBO-154 in specific types of advanced cancers.
Who can participate
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.
Locations 3
Australia (1)
Scientia Clinical Research
Randwick , New South Wales
India (1)
Tata Memorial hospital
Mumbai , Maharashtra
NOT_YET_RECRUITING
United States (1)
Honorhealth Research Institute
Scottsdale , Arizona
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
12.08.2025
Completion date
01.08.2030
Registry ID
NCT07042100
Source
anzctr
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