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Een fase 1 dosis-escalatiestudie van SLV 154 bij proefpersonen met gemetastaseerde solide tumoren

18 september 2026 bijgewerkt door: Solve Therapeutics

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

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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. Once the initial RDR is established in the Phase 1a portion of this study, further development in the Phase 1b expansion portion of this study will be considered in patients with specific cancers. In the Phase 1b part of this study, enrollment of each tumor-specific cohort will be performed using a Simon 2-stage optimal design.

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

Studietype

Ingrijpend

Inschrijving (Geschat)

250

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • California
      • Newport Beach, California, Verenigde Staten, 92663
        • Werving
        • Hoag Memorial Hospital Presbyterian
        • Contact:
    • Missouri
      • St Louis, Missouri, Verenigde Staten, 63110
        • Werving
        • Washington University
        • Contact:
    • New Jersey
      • East Brunswick, New Jersey, Verenigde Staten, 08816
    • New York
      • New York, New York, Verenigde Staten, 10065
        • Werving
        • Memorial Sloan Kettering Cancer Center
        • Contact:
    • Ohio
      • Cleveland, Ohio, Verenigde Staten, 44106
        • Werving
        • University Hospitals Cleveland Medical Center
        • Contact:
      • Columbus, Ohio, Verenigde Staten, 43210
        • Werving
        • The James Outpatient Care West Center
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19111
    • Texas
      • Houston, Texas, Verenigde Staten, 77030
        • Werving
        • MD Anderson Cancer Center
        • Contact:
      • Houston, Texas, Verenigde Staten, 77030
      • San Antonio, Texas, Verenigde Staten, 78229
        • Werving
        • Mays Cancer Center; University of Texas Health San Antonio
        • Hoofdonderzoeker:
          • Daruka Mahadevan
        • Contact:
    • Washington
      • Seattle, Washington, Verenigde Staten, 98109
        • Werving
        • University of Washington / Fred Hutchinson Cancer Center
        • Contact:
      • Tacoma, Washington, Verenigde Staten, 98405
        • Werving
        • Northwest Medical Specialties, PLLC
        • Contact:
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

12 jaar en ouder (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Men or women (as appropriate for cancer type) of age ≥12 years.
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  3. Histologically or cytologically confirmed diagnosis of advanced cancer as documented in medical records.
  4. Presence of metastatic or recurrent locally advanced cancer.
  5. Presence of radiographically measurable disease.
  6. Prior receipt of one or more commercially available therapies that are indicated within product labelling or recommended under current guidelines as appropriate treatment for the subject's cancer (unless evolving data support application of SLV-154 in previously untreated subjects with high unmet medical need and inadequate and/or poorly tolerated treatment options).
  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. Unstable malignancy involving the central nervous system.
  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 3 weeks before the start of study therapy.
  8. Use of a strong inhibitor or inducer of CYP3A4 or CYP1A2.
  9. Concurrent participation in another therapeutic or imaging clinical trial.
  10. Other conditions likely to interfere with a subject's ability to participate in the study.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Dose Level 1

0.75 mg/kg
Geneesmiddel: SLV-154

SLV-154
Experimenteel: Dose Level 2

1.5 mg/kg
Geneesmiddel: SLV-154

SLV-154
Experimenteel: Dose Level 3

3.0 mg/kg
Geneesmiddel: SLV-154

SLV-154
Experimenteel: Dose Level 4

4.0 mg/kg
Geneesmiddel: SLV-154

SLV-154
Experimenteel: Dose Level 5

5.0 mg/kg
Geneesmiddel: SLV-154

SLV-154
Experimenteel: Dose Level 6

6.5 mg/kg
Geneesmiddel: SLV-154

SLV-154

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Phase 1a: MTD and/or RDR
Tijdsspanne: 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
Phase 1b: Objective response rate (ORR)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
SLV-154 administration
Tijdsspanne: 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
SLV-154 Safety
Tijdsspanne: 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
Evaluation of use of concomitant medications
Tijdsspanne: 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
SLV-154 Pharmacokinetics
Tijdsspanne: 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
Immunogenicity
Tijdsspanne: 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
Time to Response (TTR)
Tijdsspanne: 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)
Tijdsspanne: 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
4-month progression-free survival (PFS4)
Tijdsspanne: Up to approximately 36 months

PFS4: proportion of subjects who are alive and have not experienced disease progression at 4 months after the start of study drug administration
Up to approximately 36 months
6-month progression-free survival (PFS6)
Tijdsspanne: Up to approximately 36 months

PFS6: proportion of subjects who are alive and have not experienced disease progression at 6 months after the start of study drug administration
Up to approximately 36 months
Time to treatment failure (TTF)
Tijdsspanne: 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)
Tijdsspanne: Up to approximately 36 months

OS: interval from the start of study drug administration to death from any cause
Up to approximately 36 months
Disease benefit ratio (DBR)
Tijdsspanne: Up to approximately 36 months

DBR: proportion of subjects who experience CR, PR, or stable disease with tumor reduction (SDTR)
Up to approximately 36 months
Progression free survival (PFS)
Tijdsspanne: 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
Duration of disease benefit (DDB)
Tijdsspanne: Up to approximately 36 months

DDB: interval from the first documentation of objective tumor regression to the earlier of the first documentation of disease progression or death from any cause in subjects with disease benefit
Up to approximately 36 months
Percent change in tumor dimensions
Tijdsspanne: Up to approximately 36 months

percent change from baseline in the sum of the longest diameters of non-nodal target lesions and the shortest diameters of nodal target lesions
Up to approximately 36 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Solve Therapeutics

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

14 mei 2025

Primaire voltooiing (Geschat)

1 augustus 2027

Studie voltooiing (Geschat)

1 november 2027

Studieregistratiedata

Eerst ingediend

3 januari 2025

Eerst ingediend dat voldeed aan de QC-criteria

9 januari 2025

Eerst geplaatst (Werkelijk)

13 januari 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 september 2026

Laatste update ingediend die voldeed aan QC-criteria

18 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SLV-154-01Tx

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Results will be presented in clinical study reports and publications. Individual participant data will not be shared with other researchers.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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