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RecruitingNCT07108114Updated Feb 23, 2026

SLV-324 Treatment of Metastatic Solid Tumors

A Phase 1 interventional study of SLV-324 intravenous (IV infusion) in Metastatic Solid Tumors, sponsored by Solve Therapeutics. Recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-23.

Sponsored by Solve Therapeutics · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 1 month later.
Phase
Phase 1
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Metastatic Solid Tumors
03

In context

Lead sponsor

Solve Therapeutics is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    SLV-324 intravenous (IV infusion)

    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

  • DrugSLV-324 intravenous (IV infusion)

    SLV-324 will be administered as an IV infusion

06

What researchers measure

Primary outcomes

  1. MTD or RDR

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

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

Secondary outcomes

  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

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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).

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: Up to approximately 36 months

  11. Overall Survival (OS)

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

07

Study locations

7 of 7 sites recruiting
  • 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
    • Daruka Mahadevan, MD · Contact · mahadevand@uthscsa.edu · 210-450-1000
    • Daruka Mahadevan, MD · Principal investigator
    Recruiting
  • University of Washington / Fred Hutchinson Cancer Center
    Seattle, Washington 98109, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07108114
Lead sponsor
Solve Therapeutics
Responsible party
Sponsor
First posted
Aug 6, 2025
Start date
Aug 25, 2025
Primary completion
May 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Feb 23, 2026

Study contacts

Hong Ren, MD
Contact
hren@solvetx.com
425-894-2558
Langdon L Miller, MD
Contact
lmiller@solvetx.com
908-906-6471

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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