Health Condition 1: C801- Malignant (primary) neoplasm, unspecified
Conditions
Interventions
Intervention1: SBO-154: Administered intravenously at a dose ranging from 0.3-2.5mg/kg once every 3 weeks as long as a subject continues to derive clinical benefit from the study or discontinues the s
Sponsors
Sun Pharma Advanced Research Company Limited
Eligibility
Inclusion criteria
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 and be accessible for followup. 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 or more
Exclusion criteria
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. 3. Known or suspected history of significant drug abuse as judged by the Investigator examination. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of dose-limiting toxicities (Applicable to Part 1 only) 2. Incidence of treatment-related serious adverse events 3. Incidence of treatment-related adverse eventsTimepoint: From baseline until 30 days after last dose of SBO-154 or longer if required | — |
Secondary
| Measure | Time frame |
|---|---|
| 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: From baseline to end of trial, at intervals of 6-12 weeks after the first dose of SBO-154;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: From baseline to end of trial, at intervals of 6-12 weeks after the first dose of SBO-154 ;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: From baseline to end of trial, at intervals of 6-12 weeks after the first dose of SBO-154;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: From baseline to end of trial, at intervals of 6-12 weeks after the first dose of SBO-154 ;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: From baseline to end of trial, at intervals of 6-12 weeks after the first dose of SBO-154;Incidences of ADA, titer and neutralizing antibodiesTimepoint: Survival Follow-up: Upto 1 yr | — |
Countries
Australia, India, United States of America
Contacts
Public ContactDr Sandeep Inamdar
Sun Pharma Advanced Research Limited
Outcome results
None listed