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

Shanghai Yingli Pharmaceutical

Status and phase: Not yet enrolling; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: Linperlisib Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT05429398

YY-20394-013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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118 participants in 1 patient group

Linperlisib +Camrelizumab 200mgQ3w

Experimental group

Description:

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.

Treatment:

Drug: Linperlisib Tablet