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

NCT05429398 | Unknown Phase 1

• 1 other identifier: YY-20394-013
• Study Type: interventional
• Target: 118
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Advanced Solid Tumor

Keywords

PI3K inhibitor; PD-1 inhibitor; advanced solid tumor

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Drug exposure

  At the end of Cycle 1 (each cycle is 21 days)

• PK parameters

  At the end of Cycle 1 (each cycle is 21 days)

• Effectiveness evaluation index

  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

Study Arms (1)

Linperlisib +Camrelizumab 200mgQ3w

EXPERIMENTAL

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

Interventions

Linperlisib Tablet 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.

Also known as: Camrelizumab for Injection

Linperlisib +Camrelizumab 200mgQ3w

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai YingLi Pharmaceutical Co. Ltd.: lead

MeSH Terms

Interventions

camrelizumab; Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Li Zhang, Doctor

  Cancer Hospital affiliated to Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Zhang, Doctor

CONTACT

13902282893; zhangli@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: June 23, 2022
• Study Start: June 30, 2022
• Primary Completion: August 31, 2023
• Study Completion: May 30, 2024
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share