RecruitingPhase 1interventionalRules rewrite

Phase 1: testing SI-B036 for Locally Advanced /Metastatic Solid Tumors

The objective of the study is to measure the whether it is safe and how hard side effects are to live with of SI-B036 in participants with solid tumors who have received at least one prior line of therapy for advanced disease.

Official registry: https://clinicaltrials.gov/study/NCT07857616 · SystImmune Inc. · enrollment listed as 424

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are SI-B036. The registry lists allocation as na. The objective of the study is to measure the whether it is safe and how hard side effects are to live with of SI-B036 in participants with solid tumors who have received at least one prior line of therapy for advanced disease.

They plan to enroll about 424 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

SI-B036-ST-101: A Multicenter, Open-Label, Phase 1/1b, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SI-B036 in Adult Patients With Advanced/Metastatic Solid Tumors That Are Refractory to Standard Therapies

Interventions: SI-B036

Primary outcome (registry wording): Participants with Dose-Limiting Toxicities

Who it is for (from inclusion criteria)

Ages 18 Years to any
Toxicity of previous antitumor therapy has returned to level ≤1 as defined by National Cancer Institute (NCI) Common Terminology Criteria for side effects (CTCAE) V6.0
Has no serious cardiac dysfunction and left ventricular ejection fraction ≥50%
Has adequate organ function before enrollment
PART C Additional who can join (Dose Expansion Only)
For Melanoma: histologically confirmed unresectable or metastatic melanoma with prior treatment with an immune checkpoint inhibitor regimen and documented disease progression following such therapy

Who the registry excludes

Received systemic immunostimulatory therapy within 4 weeks prior to the first dose or is still within 5 half-lives of the treatment (whichever is longer)
Received immunosuppressive drugs within 2 weeks prior to the first dose. The use of topical, inhaled, and locally injected steroids is permitted
Participants with history of severe heart disease within 6 months before enrollment
Other malignant tumors were diagnosed within 5 years prior to the first administration
For the dose escalation portion of the study only, participants with a primary diagnosis of lung cancer are excluded
Participants with a thromboembolic event (eg, deep vein thrombosis \[DVT\] or pulmonary embolism \[PE\]), stroke, or transient ischemic attack (TIA) within 6 months before screening
Active autoimmune diseases and inflammatory diseases. For autoimmune conditions that are active but stable and low-grade on systemic therapy, discussion with the medical monitor is required prior to screening

Public study contact (from the registry)

Stephanie Yee

425-453-6841

stephanie.yee@systimmune.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

7 listed

Yale Cancer Center — New Haven, Connecticut (not_yet_recruiting)
Florida Cancer Specialists Lake Nona — Orlando, Florida (recruiting)
Florida Cancer Specialists Sarasota — Sarasota, Florida (recruiting)
OU Health Stephenson Cancer Center — Oklahoma City, Oklahoma (not_yet_recruiting)
Sarah Cannon Research Institute - Oncology Partners — Nashville, Tennessee (recruiting)
Mary Crowley Cancer Research — Dallas, Texas (recruiting)
MD Anderson — Houston, Texas (not_yet_recruiting)

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FAQ about this NCT record

Is NCT07857616 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07857616?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07857616?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary