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Colorectal CancerPhase 1/2NCT04298320

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

A Phase 1/2 study testing SHR-1210 and AIN 457 in people with Colorectal Cancer, run by Yanqiao Zhang.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer
What is being tested?
SHR-1210 and AIN 457
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
15 Mar 2020to 28 Feb 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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);
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  • 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;
  • People with tuberculosis (except old tuberculosis);
  • People infected with HBV or HCV or HIV;
  • There is active infection within 2 weeks after the first use of the study drug, or there is a history of persistent infection, chronic infection or recurrent infection, or there is active skin or soft tissue infection, including cellulitis, erysipelas, pustules, abscesses or fasciitis;
  • Patients with history of inflammatory bowel disease and / or active bowel disease;
  • People with uncontrollable pain;
  • It is known that there is metastasis of central nervous system or meninges;
  • Patients with uncontrollable pleural effusion, peritoneal effusion or pericardial effusion that need clinical intervention, such as those who need periodic repeated drainage or who have had serous effusion drainage recently (within 28 days before the first application);
  • Patients with uncontrollable chronic systemic diseases (such as severe chronic lung, liver, kidney or heart diseases); patients with arrhythmia, myocardial ischemia and long-term drug control; patients with acute myocardial infarction and current congestive heart failure in the previous year; patients with unstable angina or new angina within the last three months;
  • Hypertension patients whose systolic blood pressure is less than or equal to 160mhg and diastolic blood pressure is less than or equal to 100mhg;
  • Patients with known hereditary or acquired bleeding and thrombotic tendency (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism of spleen function, etc.); patients with bleeding tendency or undergoing thrombolysis or anticoagulation treatment; patients with significant clinical bleeding symptoms or clear bleeding tendency within 3 months before screening, such as daily cough/hemoptysis 2.5ml And above, gastrointestinal bleeding, esophageal and gastric varices with bleeding risk, and hemorrhagic gastric ulcer;
  • Those who have had the event of arteriovenous thrombosis within 6 months after the first use of the study drug, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc;
  • The subjects or their partners are or intend to be pregnant, and the subjects are or intend to breastfeed are not eligible for inclusion;
  • Those who have a clear history of neurological or mental disorders (such as depression); those whose objective conditions (including psychological state, family relationship, factors or geographical factors, etc.) make the subjects unable to complete the planned study or other factors that may lead to the forced termination of the study, and those who have combined treatment or laboratory examination abnormalities; 6 Who has a history of alcohol or drug abuse or has any uncontrolled medical condition within six months;
  • According to the judgment of the researchers, there are serious hazards to the safety of the subjects, or the accompanying diseases (such as severe diabetes) that affect the subjects to complete the study;
  • The researcher judged that other subjects did not conform to the enrollment of this experiment.

Trial locations and contacts

No sites are listed yet.

Yanqiao Zhang, PhD contact

+86 138 4512 0210

yanqiaozhang@126.com

About this study

Official title: Phase Ib/IIa Study of SHR-1210 Combined With AIN457 for Patients With Late Stage MSS CRC Who Failed Second-line and Above Treatment

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.

Being tested
SHR-1210, AIN 457
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-1210Drug

    SHR-1210 was administered 200mg iv every 2 weeks

  • AIN 457Drug

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

Study groups in NCT04298320
Study groupRoleWhat they receive
SHR-1210 + AIN457ExperimentalSHR-1210 was administered 200mg iv every 2 weeks in combination with AIN457 150mg or 300mg ih every 2 weeks
Receives: Drug: SHR-1210; Drug: AIN 457

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DLT (phase Ib)

    Dose Limiting Toxicity

    Measured: Within four weeks after dosing

  2. Incidence of Treatment-Emergent Adverse Events

    adverse events/serious adverse events

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

Secondary outcomes (5)

  1. ORR

    Overall Response Rate

    Measured: From the first drug administration up to two years

  2. BOR

    Best Overall Response

    Measured: From the first drug administration up to two years

  3. DOR

    Duration of Response

    Measured: From the first drug administration up to two years

  4. DCR

    Disease Control Rate

    Measured: From the first drug administration up to two years

  5. PFS

    Progression Free Survival

    Measured: From the first drug administration up to two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2020
  2. Study start15 Mar 2020 (estimated)
  3. Primary completion28 Feb 2022 (estimated)
  4. Study completion28 Feb 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04298320
Sponsor's protocol ID
HZNB001
Status last verified
Mar 2020
First submitted
4 Mar 2020
Last updated
16 Mar 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SHR-1210 and AIN 457 in people with Colorectal Cancer, run by Yanqiao Zhang.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yanqiao Zhang, PhD (+86 138 4512 0210, yanqiaozhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT (phase Ib) (time frame: Within four weeks after dosing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04298320.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020.

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