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

Sun Pharma Advanced Research (SPARC)

Status and phase

Not yet enrolling

Phase 1

Conditions

Advanced Solid Tumors

Treatments

Biological: DL3

Biological: DL2

Biological: Dose level (DL)1

Biological: DL5

Biological: DL4

Study type

Interventional

Funder types

Industry

Identifiers

NCT07042100

SBO-154-25-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

177 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.
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.
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.
Has a life expectancy of ≥3 months.

Exclusion criteria

Any major surgery, as determined by the Investigator, within 4 weeks of SBO-154 administration.
Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination.
Known or suspected history of significant drug abuse as judged by the Investigator.
Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
Known or suspected history of excessive intake of alcohol in the 12 months prior to study entry.
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).
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.
Received an investigational agent within 30 days or 5 half-lives- whichever is shorter prior to SBO-154 administration.