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Metastatic Solid TumorsPhase 1NCT07108114

SLV-324 Treatment of Metastatic Solid Tumors

A Phase 1 study testing SLV-324 intravenous (IV infusion) in people with Metastatic Solid Tumors, run by Solve Therapeutics at 7 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Solid Tumors
What is being tested?
SLV-324 intravenous (IV infusion)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
7 sitesUnited States
Study dates
25 Aug 2025to Aug 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Hong Ren, MD contact

425-894-2558

hren@solvetx.com

Langdon L Miller, MD contact

908-906-6471

lmiller@solvetx.com

7 sites in 1 country

United States7 sites, 7 recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Megan Boland, 216-286-3379, Megan.Boland@UHhospitals.org

    Kelsi Wood, Kelsi.Wood@uhhospitals.org

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Rabia Khan, 713-563-4667, RKhan@mdanderson.org

    Recruiting

  • Mays Cancer Center; University of Texas Health San Antonio

    Houston, Texas, 78229

    Daruka Mahadevan, MD, 210-450-1000, mahadevand@uthscsa.edu

    Daruka Mahadevan, MD

    Recruiting

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

    Cindy Do, BSN, RN, 949-764-4624, cindy.do@hoag.org

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Dajah White-Dumpson, 215-728-4798, Dajah.White-Dumpson@fccc.edu

    Shannon Fabrie, shannon.fabrie@fccc.edu

    Recruiting

  • University of Washington / Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    University of Washington/Fred Hutchinson Cancer Center Phase 1 Clinical Trials, 206-606-7551, phase1clinicaltrial@fredhutch.org

    Recruiting

  • Washington University

    St Louis, Missouri, 63110

    Sara Mitchum, 314-273-8602, saram@wustl.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

A Bayesian optimal interval (BOIN) design with a target dose-limiting toxicity (DLT) rate for the maximum tolerated dose (MTD) of 27% and an estimated maximum sample size of ~70 subjects will be used to guide the dose escalation and determine the recommended dosing regimen (RDR) of SLV-324.

SLV-324 will be administered intravenously (IV) in repeated cycles. Treatment will continue until progressive disease or discontinuation.

Being tested
SLV-324 intravenous (IV infusion)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SLV-324 intravenous (IV infusion)Drug

    SLV-324 will be administered as an IV infusion

Study groups in NCT07108114
Study groupRoleWhat they receive
SLV-324 intravenous (IV infusion)ExperimentalSLV-324 will be administered at different dose levels in dose-escalation cohorts and at the RDR in dose expansion cohorts
Receives: Drug: SLV-324 intravenous (IV infusion)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD or RDR

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

    Measured: Through the duration of treatment, up to approximately 18 months

Secondary outcomes (14)

  1. SLV-324 Administration as Assessed by Prescribing Records

    Number of infusions prescribed and administered, body-weight-adjusted and total doses administered, duration of infusions, and number of infusion delays or interruptionsSLV-324 administration as assessed by prescribing records

    Measured: Through the duration of treatment, up to approximately 18 months

  2. SLV-324 Safety

    Collection of type, frequency, severity, timing of onset, duration, and relationship to study drug of any treatment-emergent adverse events (TEAEs), laboratory abnormalities, vital sign/oxygen saturation abnormalities, adverse electrocardiogram (ECG) findings, DLTs (dose-limiting toxicities), serious adverse events (SAEs), or adverse events (AEs) leading to interruption, modification, or discontinuation of study drug administration.

    Measured: Up to approximately 18 months.

  3. Evaluation of use of supportive care and other concomitant medications

    Type, frequency, and timing of use of supportive care and other concomitant medications

    Measured: Through the duration of treatment, up to approximately 18 months

  4. SLV-324 Pharmacokinetics: Maximum Concentration (Cmax)

    Cmax of SLV-324 antibody-drug conjugate, total antibody, and free payload

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

  5. Immunogenicity

    Measurement of changes in titers of circulating SLV-324-reactive antibodies (as assessed using immunoassay methods)

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

  6. Objective Response Rate (ORR)

    ORR assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR).

    Measured: Through the duration of treatment, up to approximately 18 months

  7. Time to Response (TTR)

    TTR: interval from the start of study drug administration to the first documentation of objective tumor regression.

    Measured: Up to approximately 36 months

  8. Duration of Response (DOR)

    DOR: interval from the first documentation of objective tumor regression to the earlier of the first documentation of disease progression or death from any cause.

    Measured: Up to approximately 36 months.

  9. Progression-free Survival (PFS)

    PFS: interval from the start of study drug administration to the earlier of the first documentation of disease progression or death from any cause

    Measured: Up to approximately 36 months

  10. Time to Treatment Failure (TTF)

    TTF: interval from the start of study drug administration to the earliest of the first documentation of disease progression, the permanent cessation of study drug due to an AE, or death from any cause

    Measured: Up to approximately 36 months

  11. Overall Survival (OS)

    OS: interval from the start of study drug administration to death from any cause.

    Measured: Up to approximately 36 months

  12. SLV-324 Pharmacokinetics: Time to Maximum Concentration (Tmax)

    Tmax of SLV-324 antibody-drug conjugate, total antibody, and free payload

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

  13. SLV-324 Pharmacokinetics: Area Under the Curve (AUC)

    AUC of SLV-324 antibody-drug conjugate, total antibody, and free payload

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

  14. SLV-324 Pharmacokinetics: half-life ( t1/2)

    t1/2 of SLV-324 antibody-drug conjugate, total antibody, and free payload

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2025
  2. Study start25 Aug 2025
  3. Primary completionMay 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
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.
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07108114
Sponsor's protocol ID
SLV-324-01Tx
Status last verified
Feb 2026
First submitted
24 Jul 2025
Last updated
23 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Generation of a clinical study report (CSR) and publication of results are planned but the sponsor does not currently intend to share individual participant data with other researchers.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SLV-324 intravenous (IV infusion) in people with Metastatic Solid Tumors, run by Solve Therapeutics at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hong Ren, MD (425-894-2558, hren@solvetx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD or RDR (time frame: Through the duration of treatment, up to approximately 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07108114.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.

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