A Study to Test the Safety and Tolerability of SBO-154 in Patients With Advanced Solid Tumors.
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- 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.
- 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.
- 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.
- Has a life expectancy of ≥3 months.
Exclusion criteria
- Any major surgery, as determined by the Investigator, within 4 weeks of SBO-154 administration.
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination.
- Known or suspected history of significant drug abuse as judged by the Investigator.
- Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
- Known or suspected history of excessive intake of alcohol in the 12 months prior to study entry.
- 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).
- 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.
- Received an investigational agent within 30 days or 5 half-lives- whichever is shorter prior to SBO-154 administration.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1
Study ID
NCT07042100
Intervention or treatment
BIOLOGICAL: Dose level (DL)1
BIOLOGICAL: DL2
BIOLOGICAL: DL3
BIOLOGICAL: DL4
BIOLOGICAL: DL5
Conditions
- Advanced Solid Tumors
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Research sites nearby
Closest Location:
SPARC Investigative Site
Select from list below to view details:
SPARC Investigative Site
Birtinya, Queensland, Australia
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Who is running the clinical trial?
Sun Pharma Advanced Research Company Limited
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: SBO-154
| Biological: Dose level (DL)1, Biological: DL2, Biological: DL3, Biological: DL4, Biological: DL5 |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicities | Applicable to Part 1 only | Twenty-one days from the initiation of the first dose of SBO-154 (3 weeks) |
| Incidence of treatment-related serious adverse events | Not Specified | 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 | Not Specified | Throughout the study: from the start of study drug to 30 days post the last dose of study drug. |
Secondary Outcome
| Measure | Description | 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) | Not Specified | 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) | Not Specified | 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) | Not Specified | 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) | Not Specified | 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) | Not Specified | 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) | Not Specified | Survival Follow-up: Upto 1 yr |
| Incidences of titer antibodies | Not Specified | Survival Follow-up: Upto 1 yr |
| Incidences of neutralizing antibodies | Not Specified | Survival Follow-up: Upto 1 yr |
References
Clinical Trials Gov: A Study to Test the Safety and Tolerability of SBO-154 in Patients With Advanced Solid Tumors.Other trials to consider
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