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NCT07042100PHASE1Recruiting

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

Sun Pharma Advanced Research Company Limited

Start Date

8/12/2025

Completion Date

8/1/2030

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.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

BIOLOGICAL

Dose level (DL)1

BIOLOGICAL

DL2

BIOLOGICAL

DL3

BIOLOGICAL

DL4

BIOLOGICAL

DL5

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Conditions

Advanced Solid Tumors

Locations

Honorhealth Research Institute

Scottsdale, Arizona 85258

United States

Sarcoma Oncology Research Center

Santa Monica, California 90403

United States

Yale University - Yale Cancer Center

New Haven, Connecticut 06510

United States

Hope and Healing Clinical Research LLC

Hinsdale, Illinois 60521

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

Scientia Clinical Research

Randwick, New South Wales 2031

Australia

Sunshine Coast University Private Hospital

Birtinya, Queensland 4557

Australia

Cancer Research South Australia

Adelaide, South Australia 5000

Australia

Kainos Super Speciality Hopsital

Rohtak, Haryana 124001

India

Amrita Institute of Medical Sciences

Ernākulam, Kerala 682041

India

Sir H.N Reliance Foundation Hospital

Mumbai, Maharashtra 400004

India

Tata Memorial hospital

Mumbai, Maharashtra 400012

India

Noble Hospital Pvt. Ltd.

Pune, Maharashtra 411013

India

All India Institute for Medical Sciences

Delhi, New Delhi 110029

India

S.P. Medical College and AG of Hospitals

Bikaner, Rajasthan 334003

India

Pacific Medical College and Hospital

Udaipur, Rajasthan 313001

India