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New treatment option for Squamous Cell Cancer of Head and Neck (SCCHN)
Official title SLV-154 Treatment of Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06771219
What this study is testing
What is SLV-154?
SLV-154 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for squamous cell cancer of head and neck (scchn).
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 dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-154 across a range of dose levels when administered to subjects with metastatic solid tumors.
- 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
- Men or women (as appropriate for cancer type) of age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Histologically or cytologically confirmed diagnosis of solid tumor as documented in medical records with the primary history comprising one of the...
- SCCHN
- NSCLC
You likely can't join if
- Malignancy involving the central nervous system unless brain metastases have been previously treated with radiotherapy, have been stable for ≥4...
- Presence of another cancer with disease manifestations or therapy that could adversely affect subject safety or longevity, create the potential for...
- Uncontrolled ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infection) at the time of start of study...
- Significant cardiovascular event or comorbidity.
- Significant screening ECG abnormalities.
- Pregnancy or breastfeeding.
See the full eligibility criteria
- Men or women (as appropriate for cancer type) of age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Histologically or cytologically confirmed diagnosis of solid tumor as documented in medical records with the primary history comprising one of the following:
- SCCHN
- NSCLC
- SCLC
- Breast cancer
- Cervical cancer
- Endometrial cancer
- Ovarian cancer
- Urothelial cancer
- Sarcoma
- Thyroid cancer
- Presence of metastatic disease that has progressed during or following previous treatment.
- Presence of radiographically measurable disease.
- Prior receipt of commercially available therapies that are indicated for the subject's cancer and have demonstrated survival benefit for that indication.
- Availability of tumor tissue from a fresh tumor biopsy obtained by a core needle, excisional, or incisional biopsy; or punch biopsy (for cutaneous disease); or archival tumor sample from a previous biopsy.
- Availability of computed tomography (CT) or magnetic resonance imaging (MRI) of chest, abdomen, and pelvis, and/or fluorodeoxyglucose (FDG) positron emission tomography (PET)/CT (if appropriate for tumor type) (with PET...
- Completion of all previous therapy (including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, or investigational therapy) for the treatment of cancer ≥1 week before the start of study drug...
- Adequate hematological profile.
- Adequate coagulation profile.
- Adequate hepatic profile.
- Adequate renal function.
- Negative viral serology or adequate therapy for human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection.
- For female people of childbearing potential, a negative serum pregnancy test.
- For female people of childbearing potential, willingness to use a protocol-recommended method of contraception from the start of the screening period until ≥6 months after the final dose of study therapy.
- For male people who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception, willingness to use a protocol-recommended method of contraception from...
- Willingness and ability of the subject to comply with scheduled visits, the drug administration plan, protocol-specified laboratory tests, other study procedures (including required tumor biopsy/aspirations and/or...
- Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the...
- Malignancy involving the central nervous system unless brain metastases have been previously treated with radiotherapy, have been stable for ≥4 weeks, and do not require corticosteroids.
- Presence of another cancer with disease manifestations or therapy that could adversely affect subject safety or longevity, create the potential for drug-drug interactions, or compromise the interpretation of study...
- Uncontrolled ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infection) at the time of start of study therapy.
- Significant cardiovascular event or comorbidity.
- Significant screening ECG abnormalities.
- Pregnancy or breastfeeding.
- Major surgery within 4 weeks before the start of study therapy.
- Use of a strong inhibitor or inducer of CYP3A4 or CYP1A2.
- Use of a drug known to prolong the QT interval within 7 days prior to the start of study drug administration.
- Concurrent participation in another therapeutic or imaging clinical trial.
- Other conditions likely to interfere with a subject's ability to participate in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Newport Beach, California, United States
- St Louis, Missouri, United States
- East Brunswick, New Jersey, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Seattle, Washington, United States
- Tacoma, Washington, United States
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 Newport Beach, California, United States; St Louis, Missouri, United States; East Brunswick, New Jersey, United States; New York, New York, United States; Cleveland, Ohio, United States; Houston, Texas, United States and 3 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.