En öppen etikett, multicenter, klinisk fas I-studie för att utvärdera säkerheten, effektiviteten och farmakokinetiska egenskaperna hos SIM1803-1A hos patienter med lokalt avancerade/metastaserande solida tumörer 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.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
-
Shanghai, Kina
- Shanghai Chest Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: vuxna patienter_Dos 1
|
SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles. |
|
Experimentell: vuxna patienter_Dos 2
|
SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles. |
|
Experimentell: vuxna patienter_Dos 3
|
SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles. |
|
Experimentell: vuxna patienter_Dos 4
|
SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles. |
|
Experimentell: vuxna patienter_Dos 5
|
SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles. |
|
Experimentell: vuxna patienter_Dos 6
|
SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles. |
|
Experimentell: vuxna patienter_Dos 7
|
SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles. |
|
Experimentell: vuxna patienter_Dos 8
|
SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of participants with adverse events
Tidsram: 5 years
|
Number of participants with adverse events |
5 years
|
|
Severity of adverse events
Tidsram: 5 years
|
Severity of adverse events |
5 years
|
|
Maximum tolerated dose
Tidsram: 5 years
|
Maximum tolerated dose |
5 years
|
|
Recommended dose for dose expansion
Tidsram: 5 years
|
Recommended dose for dose expansion |
5 years
|
|
Maximum concentration of SIM1803-1A in plasma (Cmax)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall Response Rate (ORR)
Tidsram: Up to 60 months
|
Overall Response Rate (ORR) |
Up to 60 months
|
|
Duration of Response (DOR)
Tidsram: Up to 60 months
|
Duration of Response (DOR) |
Up to 60 months
|
|
progression-free survival（PFS）
Tidsram: Up to 60 months
|
progression-free survival（PFS） |
Up to 60 months
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: shun lu, Ph.D, Shanghai Chest Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- SIM1803-1A-NTRK-0101
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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