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Clinical Trials in India / NCT07042100
Recruiting Phase 1

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

NCT07042100 · tracked via the Priya Life Science India tracker
Sponsor
Sun Pharma Advanced Research Company Limited
Phase
Phase 1
Started
2025-08-12
Last updated
2026-07-28

Condition(s) studied

Advanced Solid Tumors

Investigational drug(s) / intervention(s)

Dose level (DL)1DL2DL3DL4DL5

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

Study 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

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)

Trial sites (16)

FacilityCityRegionStatus
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.

View NCT07042100 on ClinicalTrials.gov ↗ ← All trials in India