A Study of Linperlisib Combination With Camrelizumab in Patients With Solid Tumor
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|ClinicalTrials.gov Identifier: NCT05429398|
Recruitment Status : Not yet recruiting
First Posted : June 23, 2022
Last Update Posted : June 23, 2022
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumor||Drug: Linperlisib Tablet||Phase 1|
The trial can be divided into two parts: dose escalation part and dose expansion part.
Camrelizumab will be administrated intravenously in a predetermined fixed dose(200mgQ3w）in both parts.
In dose escalation part,Linperlisib will be administrated from 40mgQD,60mgQD to 80 mgQD in sequence with the classic "3+3" design.The purposes of this part are figuring out the MTD and RP2D of Linperlisib combination with Camrelizumab in treating patients with advanced solid tumor,and observing the PK characteristics of Linperlisib when using combination with Camrelizumab.
When finishing the dose escalation part,one combination dose of Linperlisib with Carelizumab will be selected to be studied on a wider scale of patients with advantage solid tumor in dose expansion part.Purposes of this part are further observing the PK characteristics of Linperlisib when using combination with Camrelizumab,while observing the preliminary efficacy of Linperlisib when using combination with Camrelizumab.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||118 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-arm, Open-label, Multicenter,Phase I Study of Linperlisib Combination With Camrelizumab in Patients With Advanced Solid Tumor|
|Estimated Study Start Date :||June 30, 2022|
|Estimated Primary Completion Date :||August 31, 2023|
|Estimated Study Completion Date :||May 30, 2024|
Experimental: Linperlisib +Camrelizumab 200mgQ3w
Linperlisib will be administrated orally from 40mgQD, 60mgQD to 80mgQD in sequence during dose excalation part and a selected dose in dose expansion part,for 21 consecutive days as a treatment cycle; Camrelizumab will be administrated intravenously 200mg every 3 weeks in all patients just before the administration of Linperlisib.
Drug: Linperlisib Tablet
Other Name: Camrelizumab for Injection
- DLTs [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) ]dose limited toxicities
- TEAEs [ Time Frame: from day 1after taking the investigational product till 30 days after withdrew from the study ]treatment emergent adverse events
- Drug exposure [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) ]Peak Plasma Concentration (Cmax)
- PK parameters [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) ]Area under the plasma concentration versus time curve (AUC).etc.
- Effectiveness evaluation index [ Time Frame: From date of screening until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months ]ORR、DOR、DCR、TTR、PFS、OS
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05429398
|Contact: Li Zhang, Doctorfirstname.lastname@example.org|
|Principal Investigator:||Li Zhang, Doctor||Cancer Hospital affiliated to Sun Yat-sen University|