Pharmaceutical combination of quinoline derivative and PD-1 monoclonal antibody

A PD-1 and drug technology, applied in the field of medicine, can solve problems such as poor curative effect

Pending Publication Date: 2021-06-08
CHIA TAI TIANQING PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The biggest challenge encountered by the predecessors in the process of t

Method used

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  • Pharmaceutical combination of quinoline derivative and PD-1 monoclonal antibody
  • Pharmaceutical combination of quinoline derivative and PD-1 monoclonal antibody
  • Pharmaceutical combination of quinoline derivative and PD-1 monoclonal antibody

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0142] Embodiment 1 clinical research scheme-research standard and end point

[0143] 1.1 Inclusion and exclusion criteria

[0144] Inclusion criteria: Those who meet the following items can be included in this trial

[0145] 1) Meet all the conditions of any of the following cohorts:

[0146] Queue one:

[0147] a) Histopathologically confirmed unresectable or metastatic biliary tract cancer subjects, including intrahepatic cholangiocarcinoma (IHCC), extrahepatic cholangiocarcinoma (EHCC) and gallbladder cancer (GBC);

[0148] b) Previously failed first-line or above-line chemotherapy. The failure of first-line or more chemotherapy was defined as: disease progression during or after the last treatment; or intolerable due to toxic side effects during treatment.

[0149] Queue two:

[0150] Histopathologically confirmed recurrent or metastatic colorectal cancer with MSI-H or dMMR not suitable for surgical resection. No previous systemic therapy for recurrent or metastatic...

Embodiment 2

[0194] Embodiment 2. Clinical trial design

[0195] A single-arm, open, multi-cohort, multi-center phase II clinical trial was adopted.

[0196] 2.1 Sample size

[0197] There are 5 cohorts in this study, and 20-30 cases are enrolled in each cohort (adjusted according to the specific test results).

[0198] 2.2 Image Evaluation Design

[0199] The main efficacy endpoint of this study is ORR, which is evaluated by investigators of each research center. In this study, an independent imaging team was set up to carry out the review of imaging efficacy evaluation.

[0200] 2.3 Dosing regimen design

[0201] The administration objects are all patients recruited from cohort 1 to cohort 5 in Example 1.

[0202] The research was divided into two phases:

[0203] Phase 1 is a single-arm study with a safety lead-in period.

[0204] Patients will receive anlotinib combined with 14C12H1L1 therapy. Every 21 days is a treatment cycle, and safety information is collected to determine ...

Embodiment 3

[0235] Example 3. Collection of Biological Samples

[0236] 3.1 Detection of serum anti-14C12H1L1 antibody (ADA)

[0237] The time point of immunogenicity monitoring is based on the administration time of 14C12H1L1 injection; when the administration of 14C12H1L1 is delayed, blood collection for immunogenicity is delayed accordingly. If it is detected that the subject's ADA is positive, the neutralizing antibody will be tested additionally.

[0238] Collected before administration (-60min) in the 1st, 2nd, 4th, 8th cycle and every 6th cycle thereafter. At the same time, it was collected 30 minutes (±5 minutes) after the infusion of the first cycle and the eighth cycle, and 30 days (±7 days) and 90 days (±7 days) after the last administration. It is necessary to collect 5mL of venous blood each time, put it in a blood collection tube containing coagulation-promoting separation gel, place it at room temperature for 30 minutes, centrifuge it at 3000g for 10 minutes after natural...

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PUM

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Abstract

The invention provides a pharmaceutical composition of a quinoline derivative and a PD-1 monoclonal antibody. The pharmaceutical composition comprises a tyrosine kinase inhibitor and an immune checkpoint inhibitor. The tyrosine kinase inhibitor is a compound as shown in formula I or a pharmaceutically acceptable salt thereof. The pharmaceutical composition has good anti-tumor activity against gastrointestinal tumors, urologic neoplasms or neuroendocrine carcinomas.

Description

technical field [0001] The application belongs to the technical field of medicine, and relates to combined therapy that can be used for antitumor. Specifically, this application relates to the combination of quinoline derivatives and PD-1 monoclonal antibody and its use in anti-gastrointestinal tumors, urinary system tumors, and neuroendocrine tumors. Background technique [0002] Tyrosine kinases are a group of enzymes that catalyze the phosphorylation of protein tyrosine residues. They play an important role in intracellular signal transduction. They are involved in the regulation, signal transmission and development of normal cells, and also with the tumor cells Proliferation, differentiation, migration and apoptosis are closely related. Many receptor tyrosine kinases are associated with the formation of tumors, which can be divided into epidermal growth factor receptor (EGFR), platelet-derived growth factor receptor (PDGFR), vascular endothelial growth factor receptor ...

Claims

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Application Information

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IPC IPC(8): A61K39/395A61K31/4709A61P35/00A61P35/04
CPCA61K31/4709A61K39/39558A61P35/00A61P35/04A61K2300/00
Inventor 葛琪张喜全李百勇王训强金小平于鼎
Owner CHIA TAI TIANQING PHARMA GRP CO LTD
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