Clinical trial NCT05429398: A Study of Linperlisib Combination With Camrelizumab in Patients With Solid Tumor
Official title: A Single-arm, Open-label, Multicenter,Phase I Study of Linperlisib Combination With Camrelizumab in Patients With Advanced Solid Tumor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Solid Tumor
Keywords: PI3K inhibitor
PD-1 inhibitor
advanced solid tumor
Lead sponsor: Shanghai YingLi Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2022-06-23
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It is a single-arm, open-label, multicenter, phase I trial,aiming at exploring the MTD and RP2D of Linperlisib combination with Camrelizumab in treating patients with advanced solid tumor,observing the preliminary efficacy.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 18 years old≦age≦75 years old;
* Histologically or cytologically confirmed locally advanced or metastatic malignant solid tumors；
* Failure of previous standard treatment (sufficient prior treatment and no better treatment than participating in clinical research);
* Qualified basic organ function and body condition;
* The expected survival is greater than 3 months;
* Adequate washout period.

Exclusion Criteria:

* Prior allergy to study drug components;
* Chronic metabolic diseases that are poorly controlled by medication;
* Brain metastases, infection, hemorrhage, autoimmune disease or cardiovascular disease, whichever is in active state;
* Digestive tract diseases that affect absorption of studied drugs.

Primary outcomes:
measure: DLTs
timeFrame: At the end of Cycle 1 (each cycle is 21 days)
measure: TEAEs
timeFrame: from day 1after taking the investigational product till 30 days after withdrew from the study
Secondary outcomes:
measure: Drug exposure
timeFrame: At the end of Cycle 1 (each cycle is 21 days)
measure: PK parameters
timeFrame: At the end of Cycle 1 (each cycle is 21 days)
measure: Effectiveness evaluation index
timeFrame: 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
Other outcomes:
Locations:
Study officials:
affiliation: Cancer Hospital affiliated to Sun Yat-sen University
name: Li Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: