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
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.
Detailed description
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.
Arms & interventions
- BiologicalDose level (DL)1
Administered IV every 3 weeks
- BiologicalDL2
Administered IV every 3 weeks
- BiologicalDL3
Administered IV every 3 weeks
- BiologicalDL4
Administered IV every 3 weeks
- BiologicalDL5
Administered IV every 3 weeks
Outcome measures
Primary
Incidence of dose-limiting toxicities
Applicable to Part 1 only
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.
Secondary
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.
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.
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.
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.
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.
Incidences of anti-drug antibodies (ADA)
Time frame: Survival Follow-up: Upto 1 yr
Incidences of titer antibodies
Time frame: Survival Follow-up: Upto 1 yr
Incidences of neutralizing antibodies
Time frame: Survival Follow-up: Upto 1 yr
Eligibility criteria
Study locations (5)
Honorhealth Research Institute
Scottsdale, Arizona, 85258
Sarcoma Oncology Research Center
Santa Monica, California, 90403
Yale University - Yale Cancer Center
New Haven, Connecticut, 06510
Hope and Healing Clinical Research LLC
Hinsdale, Illinois, 60521
MD Anderson Cancer Center
Houston, Texas, 77030