424 Participants NeededMy employer runs this trial

SI-B036 for Cancer

Recruiting at 6 trial locations
SY
Overseen ByStephanie Yee
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 SI-B036, a potential drug for people with advanced solid tumors. The main goal is to assess the safety and tolerability of this treatment for patients whose cancer has progressed despite other therapies. Participants should have a solid tumor that cannot be surgically removed and have already tried at least one standard treatment without success. The trial seeks individuals whose cancer impacts their daily life and who are looking for new options. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I need to stop my current medications to join the trial?

Yes, you will need to stop certain medications before joining the trial. Specifically, you must not have had chemotherapy, biological therapy, immunotherapy, or targeted therapy within 4 weeks or 5 half-lives before the first dose, and you must not have taken immunosuppressive drugs within 2 weeks prior to the first dose.

Is there any evidence suggesting that SI-B036 is likely to be safe for humans?

A previous study showed that SI-B036 holds promise for treating solid tumors. However, detailed safety information from human trials remains unavailable. This trial is in its first phase, focusing primarily on assessing the drug's safety and tolerability. Researchers are still investigating possible side effects and how the body processes the drug. Early trials typically aim to determine the correct dose and identify any adverse reactions. Participants in this trial will contribute valuable information about the drug's safety.12345

Why do researchers think this study treatment might be promising?

Unlike other treatments for cancer that typically involve chemotherapy or targeted therapy, SI-B036 is unique because it is administered as an intravenous (IV) infusion every three weeks. Researchers are excited about SI-B036 as it may offer a new mechanism of action that targets cancer cells differently than traditional treatments. This could potentially lead to more effective outcomes and reduced side effects, providing a new hope for patients with cancer.

What evidence suggests that SI-B036 might be an effective treatment for cancer?

Research has shown that SI-B036, which participants in this trial will receive, is a new treatment designed to fight solid tumors in cancer patients. This treatment targets specific parts of cancer cells, potentially stopping their growth. Although limited information exists from human studies, early results suggest that similar treatments have slowed tumor growth in some patients. This offers hope that SI-B036 might work similarly. More studies are needed to confirm these early signs and fully understand its effectiveness.678910

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic solid tumors, such as lung cancer, melanoma, or ovarian cancer, who have already tried at least one previous treatment that did not work.

Inclusion Criteria

My organs are working well enough for treatment.
My advanced cancer can't be cured by surgery or radiation and standard treatments haven't worked.
My ovarian, peritoneal, or fallopian tube cancer came back after chemotherapy.
See 5 more

Exclusion Criteria

I have coughed up a moderate or large amount of blood.
I have received immune-boosting therapy in the last 4 weeks.
I have had recent serious bleeding or need strong blood thinners or high-dose NSAIDs.
See 19 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

SI-B036 is administered on Day 1 by intravenous (IV) infusion every 3 weeks

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • SI-B036

Trial Overview

The study is testing a new drug called SI-B036 to see if it is safe and tolerable in people with various advanced cancers. All participants will receive SI-B036.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Experimental SI-B036 administered Day 1 per cycleExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

SystImmune Inc.

Lead Sponsor

Trials
23
Recruited
1,800+

Citations

1.

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