NCT07042100

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
177

participants targeted

Target at P75+ for phase_1

Timeline
52mo left

Started Aug 2025

Longer than P75 for phase_1

Geographic Reach
3 countries

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Aug 2025Aug 2030

First Submitted

Initial submission to the registry

May 28, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 27, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

August 12, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2030

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

May 28, 2025

Last Update Submit

January 19, 2026

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

  • Incidence of dose-limiting toxicities

    Applicable to Part 1 only

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

  • Incidence of treatment-related serious adverse events

    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

    Throughout the study: from the start of study drug to 30 days post the last dose of study drug.

Secondary Outcomes (8)

  • 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: 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.

  • 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: 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.

  • 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: 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.

  • 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: 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.

  • 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: 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 more secondary outcomes

Study Arms (1)

SBO-154

EXPERIMENTAL
Biological: Dose level (DL)1Biological: DL2Biological: DL3Biological: DL4Biological: DL5

Interventions

Dose level (DL)1BIOLOGICAL

Administered IV every 3 weeks

SBO-154
DL2BIOLOGICAL

Administered IV every 3 weeks

SBO-154
DL3BIOLOGICAL

Administered IV every 3 weeks

SBO-154
DL4BIOLOGICAL

Administered IV every 3 weeks

SBO-154
DL5BIOLOGICAL

Administered IV every 3 weeks

SBO-154

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Honorhealth Research Institute

Scottsdale, Arizona, 85258, United States

RECRUITING

Sarcoma Oncology Research Center

Santa Monica, California, 90403, United States

RECRUITING

Yale University - Yale Cancer Center

New Haven, Connecticut, 06510, United States

NOT YET RECRUITING

Hope And Healing Cancer Services, Llc

Hinsdale, Illinois, 60521, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Scientia Clinical Research

Randwick, New South Wales, 2031, Australia

RECRUITING

Sunshine Coast University Private Hospital

Birtinya, Queensland, 4557, Australia

RECRUITING

Cancer Research South Australia

Adelaide, South Australia, 5000, Australia

RECRUITING

Tata Memorial hospital

Mumbai, Maharashtra, 400012, India

NOT YET RECRUITING

Noble Hospital Pvt. Ltd.

Pune, Maharashtra, 411013, India

RECRUITING

All India Institute for Medical Sciences

Delhi, New Delhi, 110029, India

RECRUITING

Central Study Contacts

Dr. Sandeep Inamdar

CONTACT

91-22-66455645clinical.trials@sparcmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2025

First Posted

June 27, 2025

Study Start

August 12, 2025

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2030

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

AU(3)IN(3)US(5)