SLV-324 Treatment of Metastatic Solid Tumors

NCT07108114 | Recruiting Phase 1 FDA Drug

• 1 other identifier: SLV-324-01Tx
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 7

Brief Summary

This is a Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-324 across a range of dose levels when administered to subjects with metastatic solid tumors.

Conditions

Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (1)

• MTD or RDR

  Determination of the MTD (maximum tolerated dose) and/or RDR (recommended dosing regimen) for SLV-324

  Through the duration of treatment, up to approximately 18 months

Secondary Outcomes (14)

• SLV-324 Administration as Assessed by Prescribing Records

  Through the duration of treatment, up to approximately 18 months

• SLV-324 Safety

  Up to approximately 18 months.

• Evaluation of use of supportive care and other concomitant medications

  Through the duration of treatment, up to approximately 18 months

• SLV-324 Pharmacokinetics: Maximum Concentration (Cmax)

  Varying timepoints through the duration of treatment, up to approximately 18 months

• Immunogenicity

  Varying timepoints through the duration of treatment, up to approximately 18 months

Study Arms (1)

SLV-324 intravenous (IV infusion)

EXPERIMENTAL

SLV-324 will be administered at different dose levels in dose-escalation cohorts and at the RDR in dose expansion cohorts

Drug: SLV-324 intravenous (IV infusion)

Interventions

SLV-324 intravenous (IV infusion) DRUG

SLV-324 will be administered as an IV infusion

SLV-324 intravenous (IV infusion)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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.
• 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 from base of the skull to mid-thigh, if performed) within 35 days before study drug administration.
• 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.
• 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 subjects of childbearing potential, a negative serum pregnancy test.

You may not qualify if:

• 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 results.
• 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.

Sponsors & Collaborators

• Solve Therapeutics: lead

Study Sites (7)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

RECRUITING

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Mays Cancer Center; University of Texas Health San Antonio

Houston, Texas, 78229, United States

RECRUITING

University of Washington / Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Interventions

Infusions, Intravenous

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

Central Study Contacts

Hong Ren, MD

CONTACT

425-894-2558; hren@solvetx.com

Langdon L Miller, MD

CONTACT

908-906-6471; lmiller@solvetx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In this study, a BOIN design with a target DLT rate for the MTD of 27% and an estimated maximum sample size of \~70 subjects will be used to guide the dose escalation and determine the RDR of SLV-324.

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 6, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)