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

A Single-arm, Open-label, Multicenter,Phase I Study of Linperlisib Combination With Camrelizumab in Patients With Advanced Solid Tumor

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: Linperlisib Tablet

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.

• Study Type: Interventional
• Enrollment (Anticipated): 118
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Li Zhang, Doctor; Phone Number: 13902282893; Email: zhangli@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Linperlisib Tablet Oral administration, once a day, for 21 consecutive days as a treatment cycle;; Camrelizumab for Injection 200 mg intravenously every 3 weeks. Camrelizumab should be administered prior to Linperlisib.; Other Names: Camrelizumab for Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DLTs	dose limited toxicities	At the end of Cycle 1 (each cycle is 21 days)
TEAEs	treatment emergent adverse events	from day 1after taking the investigational product till 30 days after withdrew from the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug exposure	Peak Plasma Concentration (Cmax)	At the end of Cycle 1 (each cycle is 21 days)
PK parameters	Area under the plasma concentration versus time curve (AUC).etc.	At the end of Cycle 1 (each cycle is 21 days)
Effectiveness evaluation index	ORR、DOR、DCR、TTR、PFS、OS	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

Collaborators and Investigators

• Sponsor: Shanghai YingLi Pharmaceutical Co. Ltd.
• Investigators: Principal Investigator: Li Zhang, Doctor, Cancer Hospital affiliated to Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 30, 2022
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): May 30, 2024

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: June 20, 2022
• First Posted (Actual): June 23, 2022

Study Record Updates

• Last Update Posted (Actual): June 23, 2022
• Last Update Submitted That Met QC Criteria: June 20, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: advanced solid tumor; PD-1 inhibitor; PI3K inhibitor
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: YY-20394-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No