177 Participants Needed

SBO-154 for Cancer

Recruiting at 3 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Sun Pharma Advanced Research Company Limited
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SBO-154 for individuals with advanced cancers that haven't responded to standard treatments. The main goal is to determine the safety of SBO-154 and its behavior in the body. This trial may suit those whose cancer has returned or spread after other treatments and who can manage the trial visits and procedures. Participants should have a life expectancy of at least three months to join. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that SBO-154 is likely to be safe for humans?

Research has shown that SBO-154 is being tested in patients with advanced cancers who haven't responded to or can't tolerate standard treatments. This Phase 1 study marks the first trial of SBO-154 in humans, so detailed safety information isn't available yet.

The main goal of this phase is to assess patient tolerance to SBO-154 and identify any side effects. As a Phase 1 study, researchers are still gathering basic safety information, so the full safety picture remains unclear. However, these studies are closely monitored to protect participants and promptly manage any side effects.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about SBO-154 because it introduces a novel approach to cancer treatment. Unlike traditional chemotherapy that targets rapidly dividing cells indiscriminately, SBO-154 works by specifically targeting cancer cell signaling pathways, which may lead to fewer side effects and improved effectiveness. This precision in targeting could result in better outcomes for patients, offering hope for a more effective and patient-friendly cancer therapy.

What evidence suggests that SBO-154 might be an effective treatment for cancer?

Initial findings suggest that SBO-154 might offer hope for patients with advanced cancers. Earlier studies have shown positive results, leading to SBO-154's inclusion in this clinical trial. Researchers are exploring this treatment for its potential to help those who haven't benefited from standard therapies. While detailed information is still being gathered, the main focus is on whether SBO-154 can effectively target and treat solid tumors. Scientists are interested in its unique approach and how it could make a difference for patients with limited options.13456

Are You a Good Fit for This Trial?

This trial is for patients with advanced solid tumors who have not responded to or can't tolerate standard treatments. Participants must expect to live at least 3 more months, be willing and able to consent, follow the study plan, and attend all visits. They cannot join if they've had major surgery recently, uncontrolled infections needing IV drugs, a history of significant alcohol or drug abuse, certain viral infections (HIV/HCV), or are pregnant.

Inclusion Criteria

Has a life expectancy of ≥3 months
My cancer has returned or worsened after standard treatment, or there is no standard treatment available.
I can and will sign a consent form and can participate in the whole study.
See 1 more

Exclusion Criteria

I do not have an infection needing IV treatment.
Known or suspected history of excessive intake of alcohol in the 12 months prior to study entry
Received an investigational agent within 30 days or 5 half-lives- whichever is shorter prior to SBO-154 administration
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Evaluation of safety, tolerability, and determination of the highest dose that can be tolerated

3 weeks
Multiple visits (in-person)

Treatment Part 2

Evaluation of the safety of SBO-154 in specific types of advanced cancers

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • SBO-154
Trial Overview The trial tests SBO-154's safety and tolerability across multiple dose levels (DL1-DL5) in people with advanced cancers. It's a Phase 1 study conducted at various centers where participants receive escalating doses of SBO-154 to determine how well it is tolerated.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: SBO-154Experimental Treatment5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sun Pharma Advanced Research Company Limited

Lead Sponsor

Trials
33
Recruited
4,600+

Citations

A Study to Test the Safety and Tolerability of SBO-154 in ...Study Overview. 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 ...
A Study to Test the Safety and Tolerability of SBO-154 in ...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 ...
SPARC Submits IND Application for SBO-154 to USFDAThese studies demonstrated favorable results, setting the stage for the upcoming clinical trials.
Sun Pharma's SBO-154: A New Hope for Advanced ...The purpose is to evaluate its effectiveness in treating advanced solid tumors. This is an interventional study with a sequential intervention ...
SBO-154 for CancerThis 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 ...
A Study to Test the Safety and Tolerability of SBO-154 in ...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 ...
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