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Tests treatment safety and results for Advanced Solid Tumors
Official title A Study to Test the Safety and Tolerability of SBO-154 in Patients With Advanced Solid Tumors.
ClinicalTrials.gov ID: NCT07042100
What this study is testing
What is Dose level (DL)1?
Dose level (DL)1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Willing and able to give written and dated informed consent (or legally acceptable representative/ impartial witness when applicable) and is...
- Willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions (in the Investigator's...
- Has locally recurrent or metastatic disease (except sarcomas) which has relapsed or progressed following local standard treatment, or for which no...
- Has a life expectancy of ≥3 months.
You likely can't join if
- 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 people with...
See the full eligibility 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.
- 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 people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Santa Monica, California, United States
- New Haven, Connecticut, United States
- Hinsdale, Illinois, United States
- Houston, Texas, United States
- Randwick, New South Wales, Australia
- Birtinya, Queensland, Australia
- Adelaide, South Australia, Australia
- Rohtak, Haryana, India
- Ernākulam, Kerala, India
- Mumbai, Maharashtra, India
- Pune, Maharashtra, India
- Delhi, New Delhi, India
- Udaipur, Rajasthan, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Santa Monica, California, United States; New Haven, Connecticut, United States; Hinsdale, Illinois, United States; Houston, Texas, United States; Randwick, New South Wales, Australia and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.