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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05429398
Recruitment Status : Not yet recruiting
First Posted : June 23, 2022
Last Update Posted : June 23, 2022
Sponsor:
Information provided by (Responsible Party):
Shanghai YingLi Pharmaceutical Co. Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: Linperlisib Tablet Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-arm, Open-label, Multicenter,Phase I Study of Linperlisib Combination With Camrelizumab in Patients With Advanced Solid Tumor
Estimated Study Start Date : June 30, 2022
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : May 30, 2024

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
  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.
Other Name: Camrelizumab for Injection




Primary Outcome Measures :
  1. DLTs [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) ]
    dose limited toxicities

  2. TEAEs [ Time Frame: from day 1after taking the investigational product till 30 days after withdrew from the study ]
    treatment emergent adverse events


Secondary Outcome Measures :
  1. Drug exposure [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) ]
    Peak Plasma Concentration (Cmax)

  2. PK parameters [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) ]
    Area under the plasma concentration versus time curve (AUC).etc.

  3. Effectiveness evaluation index [ 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 ]
    ORR、DOR、DCR、TTR、PFS、OS



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05429398


Contacts
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Contact: Li Zhang, Doctor 13902282893 zhangli@sysucc.org.cn

Sponsors and Collaborators
Shanghai YingLi Pharmaceutical Co. Ltd.
Investigators
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Principal Investigator: Li Zhang, Doctor Cancer Hospital affiliated to Sun Yat-sen University
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Responsible Party: Shanghai YingLi Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier: NCT05429398    
Other Study ID Numbers: YY-20394-013
First Posted: June 23, 2022    Key Record Dates
Last Update Posted: June 23, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai YingLi Pharmaceutical Co. Ltd.:
PI3K inhibitor
PD-1 inhibitor
advanced solid tumor
Additional relevant MeSH terms:
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Neoplasms