Recruiting
Phase 1

SBO-154

Sponsor:

Sun Pharma Advanced Research Company Limited

Code:

NCT07042100

Conditions

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dose level (DL)1

DL2

DL3

DL4

DL5

Study Details

Brief 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.

Conditions

Advanced Solid Tumors

Study ID

NCT07042100

Start date

Aug 12, 2025

Status verified date

Jul, 2026

Completion date

Aug, 2030

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

177 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SBO-154

Interventions

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

Primary outcome measure

  • Incidence of dose-limiting toxicities [ Time Frame: Twenty-one days from the initiation of the first dose of SBO-154 (3 weeks) ]
  • Incidence of treatment-related serious adverse events [ Time Frame: Throughout the study: from the start of study drug to 30 days post the last dose of study drug. ]
  • Incidence of treatment-related adverse events [ Time Frame: Throughout the study: from the start of study drug to 30 days post the last dose of study drug. ]

Central Contacts and Locations

Central contacts

Locations

Honorhealth Research Institute

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

Sarcoma Oncology Research Center

Recruiting

Santa Monica, California, United States, 90403

Contacts

Yale University - Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Hope and Healing Clinical Research LLC

Recruiting

Hinsdale, Illinois, United States, 60521

Contacts

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

More Information

Sponsor

Sun Pharma Advanced Research Company Limited

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sun Pharma Advanced Research Company Limited on 2026-07-28.