- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02575781
A Study of SAR428926 in Patients With Advanced Solid Tumors
A First-in-human Phase 1 Dose Escalation Study of SAR428926 in Patients With Advanced Solid Tumors
Primary Objectives:
To determine the maximum tolerated dose (MTD) of SAR428926 when administered as a single agent in patients with advanced solid tumors.
To evaluate the anti-tumor response of SAR428926 when administered as a single agent in patients with advanced triple negative breast cancer (TNBC) positive for the protein targeted by SAR428926 To assess the preliminary anti-tumor response of SAR428926 when administered as a single agent in patients with advanced solid tumors positive for the protein targeted by SAR428926
Secondary Objectives:
To determine the overall safety profile of SAR428926 as a single agent. To characterize the pharmacokinetics (PK) profile of SAR428926 and its metabolites.
To identify the recommended Phase 2 dose (RP2D) of SAR428926 as a single agent. To evaluate the immunogenicity of SAR428926. To assess the tumor response and duration of tumor response in all treated patients.
To evaluate the benefit of primary prophylaxis on the occurrence of corneal (keratopathy/keratitis) toxicity (Expansion cohorts).
Przegląd badań
Szczegółowy opis
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 1
Kontakty i lokalizacje
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion criteria :
- Patients with advanced solid tumor with no standard alternative treatment.
- Availability of archived tumor tissue for SAR428926 targeted antigen testing.
- For participants in the Escalation Phase: human epidermal growth factor receptor 2 (HER2) negative breast cancer (BC), gastric cancer, colorectal cancer (CRC), ovarian cancer, prostate cancer and non small-cell lung cancer (NSCLC).
- For participants in the Expansion Phase: patients with TNBC, prostate cancer, CRC, ovarian cancer or NSCLC and positive SAR428926 targeted antigen.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and one lesion amenable to biopsy in expansion cohort only (except for NSCLC patients).
Exclusion criteria:
- Age less than 18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status more than 1.
- New or progressing brain metastases.
- Concurrent treatment with any other anticancer therapy or inadequate wash-out period for prior anticancer therapies, including other experimental anticancer treatment, before first administration of SAR428926, or non resolution of toxicities induced by these anticancer therapies.
- Women of reproductive potential and male subjects with female partners of childbearing potential who are not willing to avoid pregnancy.
- Pregnancy or breast feeding.
- Prior maytansinoid treatments (DM1 or DM4 antibody drug conjugates [ADCs]).
- Unwillingness and inability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
- Significant concomitant illness, including psychiatric condition that, in the opinion of the Investigator or Sponsor, would adversely affect the patient's participation in the study.
- Any surgery within the preceding 3 weeks.
- Known human immunodeficiency virus (HIV) infection or active hepatitis B or C viral infection.
- Poor bone marrow reserve.
- Poor kidney and liver function.
- Previous history of chronic corneal diseases (even if asymptomatic) or unresolved acute non-recurrent corneal conditions. Patients wearing contact lenses who are not willing to stop wearing them for the duration of the study.
- Unresolved signs and symptoms of peripheral neuropathy; Grade 1 is acceptable.
- Abnormal cardiac function defined by a left ventricular ejection fraction (LVEF) <50%.
- Known intolerance to infused protein products including other monoclonal antibodies and ADCs.
- Medical conditions requiring concomitant administration of medications with narrow therapeutic window, metabolized by CYPs and which a dose reduction cannot be considered.
- Medical conditions requiring concomitant administration of strong CYP3A inhibitors, unless it can be discontinued at least two weeks before first administration of SAR428926.
- Other prior neoplasm.
- Contraindications to the use of ophthalmic vasoconstrictor and/or corticosteroid as per package insert of each drug, including the following: increase intraocular pressure, prior or current glaucoma, narrow-angle glaucoma, ongoing eye infection, uncontrolled hypertension, known/suspected allergy to constituents of the preparation (such as sodium bisulfite).
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: SAR428926-Escalating cohort
SAR428926 will be administered intravenously up to disease progression or dose limiting toxicities
|
Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous
|
Eksperymentalny: SAR428926 in triple negative breast cancer-Expansion Cohort 1
SAR428926 will be administered intravenously at maximum tolerated dose (MTD) up to disease progression or unacceptable toxicity
|
Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous
|
Eksperymentalny: SAR428926 in solid tumors-Expansion Cohort 2
SAR428926 will be administered intravenously at the MTD up to disease progression or unacceptable toxicity
|
Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
---|---|
Number of patients with dose limiting adverse events (Escalation cohort)
Ramy czasowe: 4 weeks
|
4 weeks
|
Number of patients with corneal adverse events impacting study treatment (Escalation cohort)
Ramy czasowe: 8 weeks
|
8 weeks
|
Assessment of overall response rate using standard imaging and RECIST v1.1 criteria (Expansion cohort)
Ramy czasowe: Tumor assessment every 2 months until disease progression or up to 36 months, whichever came first
|
Tumor assessment every 2 months until disease progression or up to 36 months, whichever came first
|
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
---|---|
Number of treatment emergent adverse events
Ramy czasowe: Up to 3 years
|
Up to 3 years
|
Assessment of PK parameter: maximum concentration (Cmax)
Ramy czasowe: 2 months
|
2 months
|
Assessment of PK parameter: time to reach maximum concentration (tmax)
Ramy czasowe: 2 months
|
2 months
|
Assessment of PK parameter: trough plasma concentration (Ctrough)
Ramy czasowe: Every 2 weeks until approximately 14 weeks
|
Every 2 weeks until approximately 14 weeks
|
Assessment of PK parameter: area under the plasma concentration curve versus time curve between 1 and 14 days (AUC0-14 day)
Ramy czasowe: 2 months
|
2 months
|
Assessment of PK parameter: mean systemic clearance (CL)
Ramy czasowe: 2 months
|
2 months
|
Assessment of PK parameter: clearance at steady state (CLss)
Ramy czasowe: 2 months
|
2 months
|
Assessment of PK parameter: accumulation ratio on AUC0-14
Ramy czasowe: 2 months
|
2 months
|
Assessment of PK parameter: accumulation ratio on Cmax
Ramy czasowe: 2 months
|
2 months
|
Preliminary tumor response by RECIST v1.1 (Escalation)
Ramy czasowe: 2 months
|
2 months
|
Number of corneal events according to the presence or not of preventive measures
Ramy czasowe: 12 weeks
|
12 weeks
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- TED14147
- 2015-001441-92 (Numer EudraCT)
- U1111-1168-4706 (Inny identyfikator: UTN)
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