A Study of Linperlisib Combination With Camrelizumab in Patients With Solid Tumor

Shanghai YingLi Pharmaceutical Co. Ltd.118 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

118

Conditions

Advanced Solid Tumor

Interventions

Linperlisib TabletDRUG

1. Linperlisib Tablet Oral administration, once a day, for 21 consecutive days as a treatment cycle; 2. Camrelizumab for Injection 200 mg intravenously every 3 weeks. Camrelizumab should be administered prior to Linperlisib.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

DLTs

dose limited toxicities

Time frame: At the end of Cycle 1 (each cycle is 21 days)

TEAEs

treatment emergent adverse events

Time frame: from day 1after taking the investigational product till 30 days after withdrew from the study

Secondary Outcomes

Drug exposure

Peak Plasma Concentration (Cmax)

Time frame: At the end of Cycle 1 (each cycle is 21 days)

PK parameters

Area under the plasma concentration versus time curve (AUC).etc.

Time frame: At the end of Cycle 1 (each cycle is 21 days)

Effectiveness evaluation index

ORR、DOR、DCR、TTR、PFS、OS

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

Central Contacts

Li Zhang, Doctor

CONTACT

13902282893 zhangli@sysucc.org.cn

Data from ClinicalTrials.gov

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