A Trial of SHR-1210 in Combination With SHR6390 in Patients With Advanced CRC, NSCLC and HCC

NCT03601598 | Unknown Phase 1

• 1 other identifier: SHR-1210-SHR6390-IIT
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase Ib/II , Open-label , Investigator-initiated Trail of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With SHR6390 (a CDK4/6 Inhibitor) in Patients With Advanced Colorectal Cancer, Non-small Cell Lung Cancer and Hepatocellular Carcinoma. The study was designed in two stages, the first stage was the tolerance observation stage, and the second stage was the curative effect expansion stage. The first part of the study is the Dose-finding Phase designed to establish the safety of SHR-1210 Combination With SHR6390 at different dose Levels(150mg QD or 100mg QD ). The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses . This study aims to evaluate the safety and efficacy of SHR-1210 combination with SHR6390 in the treatment of advanced CRC,NSCLC and HCC.

Conditions

CRC; HCC; NSCLC

Outcome Measures

Primary Outcomes (2)

• MTD /DLT (phase Ib)

  Maximum Tolerated Dose/Dose Limiting Toxicity

  Within four weeks after dosing

• ORR(phase II)

  Overall Response Rate

  from the first drug administration up to two years

Secondary Outcomes (7)

• ORR(phase Ib)

  from the first drug administration up to two years

• Incidence of Treatment-Emergent Adverse Events (phase Ib/II)

  from the first drug administration to within 90 days for the last SHR-1210 dose

• CBR (phase Ib/II)

  from the first drug administration up to last patients treatment for 6 months.

• DoR (phase Ib/II)

  from the first drug administration up to two years

• PFS(phase Ib/II)

  from the first drug administration up to two years

Study Arms (1)

SHR-1210 + SHR6390

EXPERIMENTAL

SHR-1210 was administered 200mg iv every 2 weeks in combination with SHR6390 150mg or 100mg oral daily with 3 weeks on and 1 week off

Drug: SHR-1210; Drug: SHR6390

Interventions

SHR-1210 DRUG

SHR-1210 was administered 200mg iv every 2 weeks

SHR-1210 + SHR6390

SHR6390 DRUG

SHR6390 was administered 150mg or 100mg oral daily with 3 weeks on and 1 week off

SHR-1210 + SHR6390

Eligibility Criteria

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

You may qualify if:

• Subjects voluntarily participate in this study and sign informed consent .
• Men or women aged 18-75 years
• Has confirmed by histology and cytology advanced and/or metastatic colorectal cancer patients, the advanced (Ⅲ B/Ⅳ period) in non-small cell lung cancer，Or patients with advanced hepatocellular carcinoma confirmed histologically or cytologically or clinically，At least one measurable lesion that meets the RECIST v1.1 criteria without local treatment.
• The patients can swallow pills normally.
• ECOG score was 0 or 1.
• Have a life expectancy of at least 12 weeks.
• The functions of vital organs meet the following requirements (excluding the use of any blood components and cytokines during screening) : Neutrophils≥1.5 x 109/L, Hb≥9g/dL; Plt≥90 x 109/L, ALB≥3g/dL, TSH≤ULN(Upper Limit Of Norma), TBIL ≤ 1.25 x ULN, ALT and AST ≤ 1.5 x ULN, AKP≤ 2.5 x ULN, CR≤ 1.5 x ULN
• Female Subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 3 months after the last dose of study treatment.

You may not qualify if:

• Subjects had any active autoimmune disease or history of autoimmune disease.
• Subjects are using immunosuppressive agents, or systemic, or absorptive,local hormone therapy to achieve immunosuppression. It is still in use within 2 weeks before enrollment.
• Subjects with severe allergic reactions to other monoclonal antibodies.
• The subjects had a central nervous system metastases of clinical symptoms.
• Central lung squamous cell carcinoma, or NSCLC with large vascular invasion confirmed by imaging.
• A heart condition or disease that is not well controlled.
• Subjects had active infections.
• Other clinical trials of drugs were used within 4 weeks prior to the first administration.
• The subjects have received other PD-1 antibody therapy or other immunotherapy for PD-1 / PD-L1 or CDK4/6 inhibitor treatment in the past.
• There are other factors lead to patients can not participate in this clinical study by the judgment of the investigator.

Sponsors & Collaborators

• Harbin Medical University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

MeSH Terms

Interventions

camrelizumab

Study Officials

• Yanqiao Zhang, PhD

  Harbin Medical University Cancer Hosptital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanqiao Zhang, PhD

CONTACT

138 4512 0210; yanqiaozhang@126.com

Guangyu Wang, PhD

CONTACT

18249038966; 18249038966@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the hospital

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: July 26, 2018
• Study Start: July 30, 2018
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2020
• Last Updated: July 26, 2018

Record last verified: 2018-07