Dose level (DL)1
BiologicalAdministered IV every 3 weeks
NCT Number: NCT07042100
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Scientia Clinical Research, Randwick, New South Wales, Australia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered IV every 3 weeks
Administered IV every 3 weeks
Administered IV every 3 weeks
Administered IV every 3 weeks
Administered IV every 3 weeks
Time frame: Twenty-one days from the initiation of the first dose of SBO-154 (3 weeks)
Applicable to Part 1 only
Time frame: Throughout the study: from the start of study drug to 30 days post the last dose of study drug.
Time frame: Throughout the study: from the start of study drug to 30 days post the last dose of study drug.
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.
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.
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.
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.
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.
Time frame: Survival Follow-up: Upto 1 yr
Time frame: Survival Follow-up: Upto 1 yr
Time frame: Survival Follow-up: Upto 1 yr
Contact information is provided by the study sponsor or research team.
Sun Pharma Advanced Research Company Limited
Industry
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
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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