SLV-154 Treatment of Metastatic Solid Tumors

January 22, 2026 updated by: Solve Therapeutics

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

This is a Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-154 across a range of dose levels when administered to subjects with metastatic solid tumors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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-154.

SLV-154 will be administered intravenously (IV) in repeated 3-week cycles. Treatment will continue until progressive disease or discontinuation.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoag Memorial Hospital Presbyterian
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
        • Contact:
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
      • Houston, Texas, United States, 77030
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Mays Cancer Center; University of Texas Health San Antonio
        • Principal Investigator:
          • Daruka Mahadevan
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • University of Washington / Fred Hutchinson Cancer Center
        • Contact:
      • Tacoma, Washington, United States, 98405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Level 1
0.75 mg/kg
Drug: SLV-154
SLV-154
Experimental: Dose Level 2
1.5 mg/kg
Drug: SLV-154
SLV-154
Experimental: Dose Level 3
3.0 mg/kg
Drug: SLV-154
SLV-154
Experimental: Dose Level 4
5.0 mg/kg
Drug: SLV-154
SLV-154
Experimental: Dose Level 5
7.5 mg/kg
Drug: SLV-154
SLV-154
Experimental: Dose Level 6
10.0 mg/kg
Drug: SLV-154
SLV-154
Experimental: Dose Level 7
12.5 mg/kg
Drug: SLV-154
SLV-154
Experimental: Dose Level 8
15.0 mg/kg
Drug: SLV-154
SLV-154

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MTD and/or RDR
Time Frame: Through the duration of treatment, up to approximately 18 months
Determination of the MTD (maximum tolerated dose) and/or RDR (recommended dosing regimen) for SLV-154
Through the duration of treatment, up to approximately 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SLV-154 administration
Time Frame: Through the duration of treatment, up to approximately 18 months
SLV-154 drug administration as assessed by prescribing records
Through the duration of treatment, up to approximately 18 months
Evaluation of use of concomitant medications
Time Frame: Through the duration of treatment, up to approximately 18 months
Type, frequency, and timing of use of supportive care and other concomitant medications
Through the duration of treatment, up to approximately 18 months
Immunogenicity
Time Frame: Varying timepoints through the duration of treatment, up to approximately 18 months
Measurement of changes in titers of circulating SLV 154-reactive antibodies (as assessed using immunoassay methods)
Varying timepoints through the duration of treatment, up to approximately 18 months
Objective Response Rate (ORR)
Time Frame: Through the duration of treatment, up to approximately 18 months
ORR assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria and defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR).
Through the duration of treatment, up to approximately 18 months
Time to Response (TTR)
Time Frame: Up to approximately 36 months
TTR: interval from the start of study drug administration to the first documentation of objective tumor regression
Up to approximately 36 months
Duration of Response (DOR)
Time Frame: Up to approximately 36 months
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
Up to approximately 36 months
Progression-free survival (PFS)
Time Frame: Up to approximately 36 months
PFS: interval from the start of study drug administration to the earlier of the first documentation of disease progression or death from any cause
Up to approximately 36 months
Time to treatment failure (TTF)
Time Frame: Up to approximately 36 months
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
Up to approximately 36 months
Overall survival (OS)
Time Frame: Up to approximately 36 months
OS: interval from the start of study drug administration to death from any cause
Up to approximately 36 months
SLV-154 Safety
Time Frame: Through the duration of treatment, up to approximately 18 months
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; serious adverse events (SAEs); adverse events of special interest (AESIs); or adverse events (AEs) leading to interruption, modification, or discontinuation of study drug administration.
Through the duration of treatment, up to approximately 18 months
SLV-154 Pharmacokinetics
Time Frame: Varying timepoints through the duration of treatment, up to approximately 18 months
Evaluation of the pharmacokinetic profile of SLV-154
Varying timepoints through the duration of treatment, up to approximately 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solve Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

January 3, 2025

First Submitted That Met QC Criteria

January 9, 2025

First Posted (Actual)

January 13, 2025

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLV-154-01Tx

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

A CSR and publication of results is planned but we currently do not intend to share individual participant data with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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