SLV-324 for adults with metastatic solid tumors

A Phase 1 Dose-Escalation Study of SLV-324 in Subjects With Metastatic Solid Tumors

This will try SLV-324 given by IV infusion to see if it's safe and can shrink or slow metastatic solid tumors in adults who have progressed after standard treatments.

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: 7 sites (Newport Beach, California and 6 other locations)
• Trial ID: NCT07108114 on ClinicalTrials.gov

What this trial studies

This Phase 1, dose‑escalation study gives SLV-324 by intravenous infusion in repeated cycles to adults with metastatic solid tumors. A Bayesian optimal interval (BOIN) design will guide dose escalation with a target dose‑limiting toxicity rate of 27% to identify a maximum tolerated dose and a recommended dosing regimen. The trial will collect safety, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy data across an estimated maximum of ~70 participants. Treatment continues until disease progression or discontinuation for other reasons.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with histologically confirmed metastatic solid tumors that have progressed after available standard therapies, have measurable disease, an ECOG performance status of 0–2, and can provide tumor tissue and attend visits at a study site.

Not a fit: Patients whose disease is controlled by approved treatments, who cannot tolerate IV infusions or required biopsy procedures, or who have major organ dysfunction or other exclusionary conditions are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, SLV-324 could become a new treatment option that shrinks tumors or delays progression for some patients whose metastatic disease has progressed after approved therapies.

How similar studies have performed: Phase 1 dose‑escalation designs are a common first step for new oncology agents and have sometimes identified effective drugs, but SLV-324 itself has limited prior clinical data available.

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.
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 6 other locations

• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (Recruiting)
• Washington University — St Louis, Missouri, United States (Recruiting)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (Recruiting)
• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
• Mays Cancer Center; University of Texas Health San Antonio — Houston, Texas, United States (Recruiting)
• University of Washington / Fred Hutchinson Cancer Center — Seattle, Washington, United States (Recruiting)

Study contacts

• Study coordinator: Hong Ren, MD

Conditions Metastatic Solid Tumors