A Study to Test the Safety and Tolerability of SBO-154 in Patients With Advanced Solid Tumors.
NCT ID: NCT07042100
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
177 participants
INTERVENTIONAL
2025-08-12
2030-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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SBO-154
Dose level (DL)1
Administered IV every 3 weeks
DL2
Administered IV every 3 weeks
DL3
Administered IV every 3 weeks
DL4
Administered IV every 3 weeks
DL5
Administered IV every 3 weeks
Interventions
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Dose level (DL)1
Administered IV every 3 weeks
DL2
Administered IV every 3 weeks
DL3
Administered IV every 3 weeks
DL4
Administered IV every 3 weeks
DL5
Administered IV every 3 weeks
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Sun Pharma Advanced Research Company Limited
INDUSTRY
Responsible Party
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Locations
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Honorhealth Research Institute
Scottsdale, Arizona, United States
Sarcoma Oncology Research Center
Santa Monica, California, United States
Yale University - Yale Cancer Center
New Haven, Connecticut, United States
Hope And Healing Cancer Services, Llc
Hinsdale, Illinois, United States
MD Anderson Cancer Center
Houston, Texas, United States
Scientia Clinical Research
Randwick, New South Wales, Australia
Sunshine Coast University Private Hospital
Birtinya, Queensland, Australia
Cancer Research South Australia
Adelaide, South Australia, Australia
Tata Memorial hospital
Mumbai, Maharashtra, India
Noble Hospital Pvt. Ltd.
Pune, Maharashtra, India
All India Institute for Medical Sciences
Delhi, New Delhi, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SBO-154-25-01
Identifier Type: -
Identifier Source: org_study_id
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