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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07042100




Registration number
NCT07042100
Ethics application status
Date submitted
28/05/2025
Date registered
27/06/2025
Date last updated
4/07/2025

Titles & IDs
Public title
A Study to Test the Safety and Tolerability of SBO-154 in Patients With Advanced Solid Tumors.
Scientific 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
Secondary ID [1] 0 0
SBO-154-25-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Dose level (DL)1
Treatment: Other - DL2
Treatment: Other - DL3
Treatment: Other - DL4
Treatment: Other - DL5

Experimental: SBO-154 -


Treatment: Other: Dose level (DL)1
Administered IV every 3 weeks

Treatment: Other: DL2
Administered IV every 3 weeks

Treatment: Other: DL3
Administered IV every 3 weeks

Treatment: Other: DL4
Administered IV every 3 weeks

Treatment: Other: DL5
Administered IV every 3 weeks
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of dose-limiting toxicities
Timepoint [1] 0 0
Twenty-one days from the initiation of the first dose of SBO-154 (3 weeks)
Primary outcome [2] 0 0
Incidence of treatment-related serious adverse events
Timepoint [2] 0 0
Throughout the study: from the start of study drug to 30 days post the last dose of study drug.
Primary outcome [3] 0 0
Incidence of treatment-related adverse events
Timepoint [3] 0 0
Throughout the study: from the start of study drug to 30 days post the last dose of study drug.
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
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.
Secondary outcome [2] 0 0
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)
Timepoint [2] 0 0
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.
Secondary outcome [3] 0 0
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)
Timepoint [3] 0 0
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.
Secondary outcome [4] 0 0
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)
Timepoint [4] 0 0
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.
Secondary outcome [5] 0 0
To evaluate the progression-free survival (i.e., the time from treatment start to the time of PD or death, per RECIST v1.1)
Timepoint [5] 0 0
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.
Secondary outcome [6] 0 0
Incidences of anti-drug antibodies (ADA)
Timepoint [6] 0 0
Survival Follow-up: Upto 1 yr
Secondary outcome [7] 0 0
Incidences of titer antibodies
Timepoint [7] 0 0
Survival Follow-up: Upto 1 yr
Secondary outcome [8] 0 0
Incidences of neutralizing antibodies
Timepoint [8] 0 0
Survival Follow-up: Upto 1 yr

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2030
Actual
Sample size
Target
177
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
SPARC Investigative Site - Birtinya
Recruitment postcode(s) [1] 0 0
4557 - Birtinya
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas
Country [2] 0 0
India
State/province [2] 0 0
Maharashtra
Country [3] 0 0
India
State/province [3] 0 0
New Delhi

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sun Pharma Advanced Research Company Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dr. Sandeep Inamdar
Address 0 0
Country 0 0
Phone 0 0
91-22-66455645
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07042100