A Study of SHR-A1921 for Injection in Subjects With Advanced Solid Tumours

November 29, 2021 updated by: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

A Phase 1 Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A1921 in Subjects With Advanced Malignant Solid Tumour .

To assess the safety and tolerability of SHR-A1921 in patients with advanced solid tumours, to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and/or recommended phase II dose (RP2D) of SHR-A1921

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Voluntary participation and written informed consent；
  2. Aged 18-75 years (inclusive), males and females;
  3. Consents to provide tumor tissue samples;
  4. Subjects must have histologically or clinically confirmed advanced and/or metastatic malignancies for which failure of standard treatment or lack of effective standard treatment;
  5. At least one measurable lesion according to RECIST v1.1;
  6. ECOG score of 0-1;
  7. Expected survival ≥ 12 weeks;
  8. Adequate bone marrow reserve and organ function ；
  9. For female patients of childbearing potential or male patients with partners of childbearing potential who are not sterilized by surgical operations, they are required to use a medically approved contraceptive measure during the study treatment period and within 3 months after the end of the study treatment; For female patients of childbearing potential who are not sterilized by surgical operations, they must have a negative serum HCG test result within 72 h prior to study enrollment; and they must not be in the lactation period;

Exclusion Criteria:

  1. Known and untreated central nervous system (CNS) or leptomeningeal metastases;
  2. Macrovascular invasion based on imaging;
  3. Cancerous ascites, pleural effusion or pericardial effusion with clinical symptoms;
  4. Has a history of a second malignancy;
  5. History of immunodeficiency disease or organ transplant;
  6. Uncontrolled cardiac diseases or symptoms;
  7. Has a history of non-infectious ILD/pneumonitis that required steroids, or has current ILD/pneumonitis;
  8. Has a history of active chronic enteritis 6 weeks prior to the initiation of the study treatment or intestinal obstruction, gastrointestinal perforation 3 months prior to the initiation of the study treatment;
  9. Has a history of Grade≥2 bleeding 4 weeks prior to the initiation of the study treatment or is current receiving anticoagulation therapy;
  10. Subjects with active hepatitis B or active hepatitis C;
  11. Subjects who have received systemic anti-tumor treatments 4 weeks prior to the initiation of the study treatment.
  12. Has unresolved toxicities from previous anticancer therapy.
  13. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A1921;
  14. Subjects with other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of the patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment group: SHR-A1921
Drug: SHR-A1921
Treatment group: Subjects will receive an intravenous infusion of SHR-A1921 in a dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dose Limited Toxicity (DLT)
Time Frame: 21 Days (first cycle)
21 Days (first cycle)
Maximum Tolerable Dose (MTD)
Time Frame: 21 Days (first cycle)
21 Days (first cycle)
Recommended phase II dose (RP2D)
Time Frame: Screening up to dose escalation and expansion study completion, appropriately to 1 year
Screening up to dose escalation and expansion study completion, appropriately to 1 year
Adverse Events
Time Frame: Screening up to study completion, an average of 1 year
Incidence and grade of adverse events as assessed by CTCAE v5.0
Screening up to study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time to reach maximum concentration (Tmax) of SHR-A1921、total antibody
Time Frame: Screening up to end of treatment, an average of 1 year
Screening up to end of treatment, an average of 1 year
Maximum concentration (Cmax) of SHR-A1921、total antibody
Time Frame: Screening up to end of treatment, an average of 1 year
Screening up to end of treatment, an average of 1 year
Area under the concentration-time curve from time zero to the time of the last quantifiable time point t (AUC0-t) of SHR-A1921、total antibody
Time Frame: Screening up to end of treatment, an average of 1 year
Screening up to end of treatment, an average of 1 year
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-t) of SHR-A1921、total antibody
Time Frame: Screening up to end of treatment, an average of 1 year
Screening up to end of treatment, an average of 1 year
Terminal half-life (t1/2) of SHR-A1921、total antibody
Time Frame: Screening up to end of treatment, an average of 1 year
Screening up to end of treatment, an average of 1 year
Total body clearance (CL) of SHR-A1921、total antibody
Time Frame: Screening up to end of treatment, an average of 1 year
Screening up to end of treatment, an average of 1 year
Volume of distribution at steady state (Vss) of SHR-A1921、total antibody
Time Frame: Screening up to end of treatment, an average of 1 year
Screening up to end of treatment, an average of 1 year
Mean residence time (MRT) of SHR-A1921、total antibody
Time Frame: Screening up to end of treatment, an average of 1 year
Screening up to end of treatment, an average of 1 year
Maximum steady-state drug concentration during a dosage interval (Css, max) of SHR-A1921、total antibody
Time Frame: Screening up to end of treatment, an average of 1 year
Screening up to end of treatment, an average of 1 year
Minimum steady-state drug concentration during a dosage interval (Css, min) of SHR-A1921、total antibody
Time Frame: Screening up to end of treatment, an average of 1 year
Screening up to end of treatment, an average of 1 year
Accumulation ratio (Rac) of SHR-A1921、total antibody
Time Frame: Screening up to end of treatment, an average of 1 year
Screening up to end of treatment, an average of 1 year
Anti-drug antibody(ADA) level of SHR-A1921
Time Frame: Screening up to 90 days after the last dose, an average of 1 year
Screening up to 90 days after the last dose, an average of 1 year
Objective Response Rate (ORR) assessed by site investigator as per RECIST 1.1
Time Frame: Screening up to study completion, an average of 1 year
Screening up to study completion, an average of 1 year
Duration of Response (DoR) assessed by site investigator as per RECIST 1.1
Time Frame: Screening up to study completion, an average of 1 year
Screening up to study completion, an average of 1 year
Disease Control Rate (DCR) assessed by site investigator as per RECIST 1.1
Time Frame: Screening up to study completion, an average of 1 year
Screening up to study completion, an average of 1 year
Progression-Free Survival (PFS) assessed by site investigator as per RECIST 1.1
Time Frame: Screening up to study completion, an average of 1 year
Screening up to study completion, an average of 1 year
Overall Survival (OS)
Time Frame: Screening up to study completion, an average of 1 year
Screening up to study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 31, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHR-A1921-I-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings