Treatment of metastatic solid tumors with SLV-154

A Phase 1 Dose-Escalation Study of SLV-154 in Subjects With Metastatic Solid Tumors

This study is testing a new treatment called SLV-154 for people with advanced solid tumors, like certain types of lung and breast cancer, to see how safe it is and how well it works.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Solve Therapeutics (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 9 sites (Newport Beach, California and 8 other locations)
• Trial ID: NCT06771219 on ClinicalTrials.gov

What this trial studies

This Phase 1 dose-escalation study evaluates the safety and efficacy of SLV-154 in patients with metastatic solid tumors, including various types of cancer such as squamous cell carcinoma of the head and neck, non-small cell lung cancer, and breast cancer. The study employs a Bayesian optimal interval design to determine the maximum tolerated dose and recommended dosing regimen for SLV-154, which will be administered intravenously in repeated 3-week cycles. The trial aims to assess pharmacokinetics, pharmacodynamics, and immunogenicity, with treatment continuing until disease progression or discontinuation.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed metastatic solid tumors that have progressed after previous treatments.

Not a fit: Patients with non-metastatic disease or those who have not received prior therapies that demonstrate survival benefit may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with metastatic solid tumors who have limited treatment alternatives.

How similar studies have performed: Other studies have shown promise with similar dose-escalation approaches in treating metastatic cancers, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Men or women (as appropriate for cancer type) of age ≥18 years.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
3. Histologically or cytologically confirmed diagnosis of solid tumor as documented in medical records with the primary history comprising one of the following:

   1. SCCHN
   2. NSCLC
   3. SCLC
   4. Breast cancer
   5. Cervical cancer
   6. Endometrial cancer
   7. Ovarian cancer
   8. Urothelial cancer
   9. Sarcoma
   10. Thyroid cancer
4. Presence of metastatic disease that has progressed during or following previous treatment.
5. Presence of radiographically measurable disease.
6. Prior receipt of commercially available therapies that are indicated for the subject's cancer and have demonstrated survival benefit for that indication.
7. 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.
8. 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 from base of the skull to mid-thigh, if performed) within 35 days before study drug administration.
9. 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 administration.
10. Adequate hematological profile.
11. Adequate coagulation profile.
12. Adequate hepatic profile.
13. Adequate renal function.
14. Negative viral serology or adequate therapy for human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection.
15. For female subjects of childbearing potential, a negative serum pregnancy test.
16. For female subjects 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.
17. For male subjects 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 the start of study therapy until ≥6 months after the final dose of study therapy and to refrain from sperm donation from the start of study therapy until ≥12 months after administration of the final dose of study therapy.
18. 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 radiographic studies), and study restrictions.
19. 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 therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.

Exclusion Criteria:

1. 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.
2. 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 results.
3. Uncontrolled ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infection) at the time of start of study therapy.
4. Significant cardiovascular event or comorbidity.
5. Significant screening ECG abnormalities.
6. Pregnancy or breastfeeding.
7. Major surgery within 4 weeks before the start of study therapy.
8. Use of a strong inhibitor or inducer of CYP3A4 or CYP1A2.
9. Use of a drug known to prolong the QT interval within 7 days prior to the start of study drug administration.
10. Concurrent participation in another therapeutic or imaging clinical trial.
11. Other conditions likely to interfere with a subject's ability to participate in the study.

Where this trial is running

Newport Beach, California and 8 other locations

• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (Recruiting)
• Washington University — St Louis, Missouri, United States (Recruiting)
• Astera Cancer Care — East Brunswick, New Jersey, United States (Recruiting)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
• Oncology Consultants — Houston, Texas, United States (Recruiting)
• Mays Cancer Center; University of Texas Health San Antonio — San Antonio, Texas, United States (Recruiting)
• University of Washington / Fred Hutchinson Cancer Center — Seattle, Washington, United States (Recruiting)
• Northwest Medical Specialties, PLLC — Tacoma, Washington, United States (Recruiting)

Study contacts

• Study coordinator: Hong Ren, MD

Conditions Squamous Cell Cancer of Head and Neck; NSCLC; SCLC; Cervical Cancer Metastatic; Breast Cancer Metastatic; Endometrial Cancer; Ovarian Cancer; Urothelial Cancer