A Trial of SHR-1210 in Combination With AIN457 in Patients With MSS CRC（SHR-1210-AIN457）

NCT04298320 | Unknown Phase 1

• 1 other identifier: HZNB001
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase Ib/IIa, Open-label, Investigator-initiated Trail of SHR-1210 (an Anti-PD-1 Inhibitor) in combination with AIN457 for patients with late stage MSS CRC who failed second-line and above treatment. The main purpose of this study is to evaluate the safety, tolerability and RD of SHR-1210 combination with AIN457 as a treatment of MSS CRC.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• DLT (phase Ib)

  Dose Limiting Toxicity

  Within four weeks after dosing

• Incidence of Treatment-Emergent Adverse Events

  adverse events/serious adverse events

  from the first drug administration to within 90 days for the last SHR-1210 and AIN 457 dose

Secondary Outcomes (5)

• ORR

  From the first drug administration up to two years

• BOR

  From the first drug administration up to two years

• DOR

  From the first drug administration up to two years

• DCR

  From the first drug administration up to two years

• PFS

  From the first drug administration up to two years

Study Arms (1)

SHR-1210 + AIN457

EXPERIMENTAL

SHR-1210 was administered 200mg iv every 2 weeks in combination with AIN457 150mg or 300mg ih every 2 weeks

Drug: SHR-1210; Drug: AIN 457

Interventions

SHR-1210 DRUG

SHR-1210 was administered 200mg iv every 2 weeks

SHR-1210 + AIN457

AIN 457 DRUG

AIN457 was administered 150mg or 300mg ih every 2 weeks

SHR-1210 + AIN457

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;
• Patients with advanced colorectal cancer who failed to receive second-line or more standard treatment confirmed by pathology A)At least one measurable lesion that meets the RECIST v1.1 criteria; B)Microsatellite stability (MSS) required;
• ECOG score was 0 or 1;
• Have a life expectancy of at least 12 weeks;
• The functions of vital organs meet the following requirements:
• A) Sufficient bone marrow reserve: neutrophil absolute count ≥ 1.5x109/l, platelet ≥ 90x109 / L, hemoglobin ≥ 9 g / dl; B) Liver: plasma albumin ≥ 2.8g/dl; bilirubin ≤ 1.5 times of upper limit of normal value (ULN); ALT and AST ≤ 2.5uln, if there is liver metastasis, ALT and AST ≤ 5xuln; C) Kidney: serum creatinine ≤ 1.5 times ULN; D) Heart: left ventricular ejection fraction (LVEF) ≥ 50%; E) Coagulation: prothrombin time (PT) \< 1.5 times ULN, INR ≤ 1.5 times ULN, APTT ≤ 1.5 times ULN; F) TSH ≤ ULN (if abnormal, FT3 and FT4 levels should be examined at the same time, if FT3 and FT4 levels are normal, they can be included in the group;
• 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;
• Patients can provide more than 8 pathological sections of previous and / or fresh tissue lesions;
• Volunteer to participate in this clinical trial, willing and able to follow the procedures related to clinical visit and research, understand the research procedures and have signed the informed consent.

You may not qualify if:

• Those who have received anti-IL-17 or IL-23 drug treatment;
• Have received PD-1 antibody treatment or other immunotherapy for PD-1/PD-L1;
• Those who have received chemotherapy, molecular targeted drugs and anti-tumor drugs of traditional Chinese medicine within one month after the first use of the research drug;
• The adverse reactions (except hair loss) caused by previous treatment did not recover to ≤ CTCAE level 1;
• Those who have received radiotherapy and interventional treatment within one month after the first use of the study drug;
• Those who have received major surgery or active ulcer or incomplete wound healing within one month after the first use of the study drug (excluding central vein catheterization, tumor tissue biopsy or nasogastric tube catheterization);
• Those who received live attenuated vaccine within one month after the first use of the study drug or expected to receive live attenuated vaccine treatment during the study period;
• Those who are expected to undergo elective surgery during the study period;
• Those who received transfusion of blood products and injection of hematopoietic colony stimulating growth factor (such as G-CSF, GMCSF, M-CSF) within 14 days after the first use of the study drug;
• Participants in another intervention clinical trial within one month after the first use of the study drug;
• Within 5 years after the first use of the study drug or at the same time with other malignant tumors (except for cured skin basal cell carcinoma, cervical carcinoma in situ and ovarian cancer);
• Patients with active autoimmune disease, or history of immunodeficiency and autoimmune disease, or disease history or syndrome requiring immunosuppressive drug treatment; (such as the following, but not limited to: asthma, idiopathic pulmonary fibrosis, bronchiolitis obliterans, colitis, drug pneumonia, idiopathic or interstitial pneumonia, autoimmune hepatitis, pituitary gland Inflammation, vasculitis, nephritis, uveitis, systemic lupus erythematosus, hyperthyroidism, hypothyroidism; patients with asthma in childhood have been completely relieved, and can be included in adults without any intervention, but asthma patients who need medical intervention with bronchodilator cannot be included);
• Need systemic steroid hormone treatment;
• Intestinal obstruction or fistula occurred within 3 months after the first use of the study drug;
• Those who have ever had serious hypersensitivity reaction (defined as: the patients can't be relieved quickly after symptomatic treatment and / or infusion treatment; relapse after taking effect; leave the sequelae requiring hospitalization treatment); those who have allergic reaction to latex products;

Sponsors & Collaborators

• Yanqiao Zhang: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

camrelizumab; secukinumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Yanqiao Zhang, PhD

  Harbin Medical University Cancer Hosptital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanqiao Zhang, PhD

CONTACT

+86 138 4512 0210; yanqiaozhang@126.com

Study Design

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

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 6, 2020
• Study Start: March 15, 2020
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2023
• Last Updated: March 16, 2020

Record last verified: 2020-03