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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-30

Study Completion Date

2024-05-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Linperlisib Tablet

Intervention Type DRUG

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.

Interventions

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Linperlisib Tablet

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.

Intervention Type DRUG

Other Intervention Names

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Camrelizumab for Injection

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No