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

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05429398
• Other study ID #: YY-20394-013
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 30, 2022
• Est. completion date: May 30, 2024

Study information

• Verified date: June 2022
• Source: Shanghai YingLi Pharmaceutical Co. Ltd.
• Contact: Li Zhang, Doctor
• Phone: 13902282893
• Email: zhangli[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 118
• Est. completion date: May 30, 2024
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai YingLi Pharmaceutical Co. Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DLTs	dose limited toxicities	At the end of Cycle 1 (each cycle is 21 days)
Primary	TEAEs	treatment emergent adverse events	from day 1after taking the investigational product till 30 days after withdrew from the study
Secondary	Drug exposure	Peak Plasma Concentration (Cmax)	At the end of Cycle 1 (each cycle is 21 days)
Secondary	PK parameters	Area under the plasma concentration versus time curve (AUC).etc.	At the end of Cycle 1 (each cycle is 21 days)
Secondary	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