Et åbent, multicenter, fase I klinisk studie til evaluering af sikkerheden, effektiviteten og farmakokinetiske egenskaber af SIM1803-1A hos patienter med lokalt avancerede/metastatiske solide tumorer med NTRK-, ROS1- eller ALK-genfusionsmutationer.
This research study is done to test the safety, effectiveness and pharmacokinetic characteristics of SIM1803-1A in patients with locally advanced/metastatic solid tumors with NTRK, ROS1 or ALK gene fusion mutations. The cancer must have a change in a particular gene (NTRK1, NTRK2, NTRK3, ROS1 or ALK). SIM1803-1A is a drug that blocks the actions of these NTRK/ ROS1 /ALK genes in cancer cells and can therefore be used to treat cancer.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
-
Shanghai, Kina
- Shanghai Chest Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Adult patients with a locally advanced or metastatic solid tumor that has progressed or was nonresponsive to available therapies, are unfit for standard chemotherapy or for which no standard or available curative therapy exists；Proof of a malignancy harboring a NTRK、ROS1 or ALK fusion；Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 and a life expectancy of at least 3 month；Adequate hematologic, hepatic, and renal function；Signed informed consent form；
Exclusion Criteria:
- Any contraindications as listed in the local approved product information；Patients with unstable primary central-nervous-system tumors or metastasis, exceptions possible；Pregnancy or lactation；Clinically significant active cardiovascular disease or history of myocardial infarction；Participation in an investigational program with interventions outside of routine clinical practice；Prior treatment with other kinase inhibitor with tropomyosin receptor kinase inhibition；Active uncontrolled systemic bacterial, viral, or fungal infection；Current treatment with a strong CYP3A4 inhibitor or inducer；
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: voksne patienter_Dosis 1
|
SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles. |
|
Eksperimentel: voksne patienter_Dosis 2
|
SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles. |
|
Eksperimentel: voksne patienter_Dosis 3
|
SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles. |
|
Eksperimentel: voksne patienter_Dosis 4
|
SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles. |
|
Eksperimentel: voksne patienter_Dosis 5
|
SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles. |
|
Eksperimentel: voksne patienter_Dosis 6
|
SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles. |
|
Eksperimentel: voksne patienter_Dosis 7
|
SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles. |
|
Eksperimentel: voksne patienter_Dosis 8
|
SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants with adverse events
Tidsramme: 5 years
|
Number of participants with adverse events |
5 years
|
|
Severity of adverse events
Tidsramme: 5 years
|
Severity of adverse events |
5 years
|
|
Maximum tolerated dose
Tidsramme: 5 years
|
Maximum tolerated dose |
5 years
|
|
Recommended dose for dose expansion
Tidsramme: 5 years
|
Recommended dose for dose expansion |
5 years
|
|
Maximum concentration of SIM1803-1A in plasma (Cmax)
Tidsramme: Predose and 0.25, 0.5, 1, 2, 4, 8，12，24and 48 hours after drug administration on Days 1 and 8 of Cycle 1（each cycle is 21 days）
|
Maximum concentration of SIM1803-1A in plasma (Cmax) |
Predose and 0.25, 0.5, 1, 2, 4, 8，12，24and 48 hours after drug administration on Days 1 and 8 of Cycle 1（each cycle is 21 days）
|
|
Area under the concentration-time curve of SIM1803-1A in plasma from time 0 to 24 hours in fasted state (AUC(0-24)_fasted)
Tidsramme: Up to 1 day
|
Area under the concentration-time curve of SIM1803-1A in plasma from time 0 to 24 hours in fasted state (AUC(0-24)_fasted) |
Up to 1 day
|
|
Area under the concentration-time curve of SIM1803-1A in plasma from time 0 to infinity in fasted state (AUC_fasted)
Tidsramme: Up to 3 days
|
Area under the concentration-time curve of SIM1803-1A in plasma from time 0 to infinity in fasted state (AUC_fasted) |
Up to 3 days
|
|
Number of participants with treatment-emergent adverse events (TEAEs)
Tidsramme: Up to 24 weeks
|
Number of participants with treatment-emergent adverse events (TEAEs) |
Up to 24 weeks
|
|
Time to maximum concentration of SIM1803-1A in plasma (Tmax)
Tidsramme: Predose and 0.25, 0.5, 1, 2, 4, 8，12，24and 48 hours after drug administration on Days 1 and 8 of Cycle 1（each cycle is 21 days)
|
Time to maximum concentration of SIM1803-1A in plasma (Tmax) |
Predose and 0.25, 0.5, 1, 2, 4, 8，12，24and 48 hours after drug administration on Days 1 and 8 of Cycle 1（each cycle is 21 days)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Response Rate (ORR)
Tidsramme: Up to 60 months
|
Overall Response Rate (ORR) |
Up to 60 months
|
|
Duration of Response (DOR)
Tidsramme: Up to 60 months
|
Duration of Response (DOR) |
Up to 60 months
|
|
progression-free survival（PFS）
Tidsramme: Up to 60 months
|
progression-free survival（PFS） |
Up to 60 months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: shun lu, Ph.D, Shanghai Chest Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- SIM1803-1A-NTRK-0101
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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