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NCT Number: NCT07042100

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Scientia Clinical Research, Randwick, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dose level (DL)1

Biological

Administered IV every 3 weeks

DL2

Biological

Administered IV every 3 weeks

DL3

Biological

Administered IV every 3 weeks

DL4

Biological

Administered IV every 3 weeks

DL5

Biological

Administered IV every 3 weeks

Primary outcomes

  1. Incidence of dose-limiting toxicities

    Time frame: Twenty-one days from the initiation of the first dose of SBO-154 (3 weeks)

    Applicable to Part 1 only

  2. 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.

  3. 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.

Secondary outcomes

  1. To evaluate the overall response rate (i.e., the percentage of participants who achieved a best response of Complete Response (CR) or Partial Response (PR), per RECIST v1.1)

    Time frame: Time Frame: Assessed every 6 weeks from the date of first study drug administration until the date of first documented disease progression, or death, whatever comes first; assessed for an average of 12 months.

  2. To evaluate the duration of response (i.e., the time from the initial response (CR or PR) to the time of progression of disease (PD) or death, per RECIST v1.1)

    Time frame: Time Frame: Assessed every 6 weeks from the date of first study drug administration until the date of first documented disease progression, or death, whatever comes first; assessed for an average of 12 months.

  3. To evaluate the disease control rate (i.e., the percentage of participants who achieved a best response of CR, PR, or remained stable disease (SD), per RECIST v1.1)

    Time frame: Time Frame: Assessed every 6 weeks from the date of first study drug administration until the date of first documented disease progression, or death, whatever comes first; assessed for an average of 12 months.

  4. To evaluate the time to response (i.e., the time from treatment start to the time-point where a best response of CR or PR was achieved, per RECIST v1.1)

    Time frame: Time Frame: Assessed every 6 weeks from the date of first study drug administration until the date of first documented disease progression, or death, whatever comes first; assessed for an average of 12 months.

  5. To evaluate the progression-free survival (i.e., the time from treatment start to the time of PD or death, per RECIST v1.1)

    Time frame: Time Frame: Assessed every 6 weeks from the date of first study drug administration until the date of first documented disease progression, or death, whatever comes first; assessed for an average of 12 months.

  6. Incidences of anti-drug antibodies (ADA)

    Time frame: Survival Follow-up: Upto 1 yr

  7. Incidences of titer antibodies

    Time frame: Survival Follow-up: Upto 1 yr

  8. Incidences of neutralizing antibodies

    Time frame: Survival Follow-up: Upto 1 yr

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Sandeep Inamdar

CONTACT

[email protected]

91-22-66455645

Sponsors and collaborators

Lead sponsor

Sun Pharma Advanced Research Company Limited

Industry

Registry information

Official study title

A Phase 1, Multicentre, Open-label, Multiple-dose Study to Determine Safety, Tolerability, and Preliminary Efficacy of SBO-154 in Subjects With Advanced Solid Tumors

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Jun 27, 2025
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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