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Badanie fazy 1 dotyczące zwiększania dawki SLV 154 u pacjentów z przerzutowymi guzami litymi

18 września 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

250

Faza

  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

12 lat i starsze (Dziecko, Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Zadanie sekwencyjne
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Dose Level 1

0.75 mg/kg
Lek: SLV-154

SLV-154
Eksperymentalny: Dose Level 2

1.5 mg/kg
Lek: SLV-154

SLV-154
Eksperymentalny: Dose Level 3

3.0 mg/kg
Lek: SLV-154

SLV-154
Eksperymentalny: Dose Level 4

4.0 mg/kg
Lek: SLV-154

SLV-154
Eksperymentalny: Dose Level 5

5.0 mg/kg
Lek: SLV-154

SLV-154
Eksperymentalny: Dose Level 6

6.5 mg/kg
Lek: SLV-154

SLV-154

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Phase 1a: MTD and/or RDR
Ramy czasowe: 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)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
SLV-154 administration
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Solve Therapeutics

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

14 maja 2025

Zakończenie podstawowe (Szacowany)

1 sierpnia 2027

Ukończenie studiów (Szacowany)

1 listopada 2027

Daty rejestracji na studia

Pierwszy przesłany

3 stycznia 2025

Pierwszy przesłany, który spełnia kryteria kontroli jakości

9 stycznia 2025

Pierwszy wysłany (Rzeczywisty)

13 stycznia 2025

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

22 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

18 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • SLV-154-01Tx

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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