Advanced Solid Tumors
Conditions
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.
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.
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
Sponsors
Sun Pharma Advanced Research Company Limited
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of dose-limiting toxicities | Twenty-one days from the initiation of the first dose of SBO-154 (3 weeks) | Applicable to Part 1 only |
| 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
| 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) | 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. |
| Incidences of anti-drug antibodies (ADA) | Survival Follow-up: Upto 1 yr |
| Incidences of titer antibodies | Survival Follow-up: Upto 1 yr |
| Incidences of neutralizing antibodies | Survival Follow-up: Upto 1 yr |
Countries
Australia, India, United States
Contacts
CONTACTDr. Sandeep Inamdar
Outcome results
None listed