A Trial of SHR-A1921 for Injection in Subjects With Advanced Solid Tumors

June 23, 2024 updated by: Atridia Pty Ltd.

An Open-Label, Multi-Center Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of SHR-A1921 for Injection in Subjects With Advanced Solid Tumors

The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of SHR-1921.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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 (Actual)

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.
9

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

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2031
        • Scientia Clinical Research
      • Sydney, New South Wales, Australia, 2109
        • Macquarie Hospital
      • Sydney, New South Wales, Australia, 2170
        • Sydney South West Private Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4101
        • Icon Cancer Centre

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

Description

Inclusion Criteria:

  1. Able and willing to provide a written informed consent
  2. Subjects consented and willing to provide required tumor tissue of sufficient quantity and of adequate tumor tissue content
  3. Male or female
  4. Subjects with clinically or pathologically confirmed advanced (recurrent, unresectable or metastatic) solid tumors who have failed prior standard of care therapy
  5. ECOG performance status of 0-1

Exclusion Criteria:

  1. Has uncontrolled clinically symptomatic pleural effusion, pericardial effusion, carcinomatous ascites
  2. Has untreated brain metastasis, or with concomitant meningeal metastasis or spinal cord compression
  3. Has known history of other documented malignancy
  4. Has known history of acquired immunodeficiency syndrome (AIDS)
  5. Has significant cardiovascular disease that is not well controlled, such as: (1) New York Heart Association (NYHA) Grade ≥ 2 cardiac failure
  6. Has active or prior documented interstitial pneumonia/interstitial lung disease
  7. Has experienced Grade ≥ 2 hemorrhage events within 4 weeks prior to the first dose
  8. Has known active hepatitis B
  9. Has known allergies to SHR-1921 component
  10. Has other potential factors that may interfere with the study results, or result in the premature discontinuation as determined by the investigator.

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: SHR-1921
Drug: SHR-1921
Subject will receive a single dose of SHR-1921 at dose level 1/2/3 on Day of each cycles

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
Number of subjects with adverse events (AEs)
Time Frame: Screening up to study completion, an average of 1 year
To check the numbers of AEs happened during the course of trial.
Screening up to study completion, an average of 1 year
Number of subjects with laboratory tests findings of potential clinical importance
Time Frame: Screening up to study completion, an average of 1 year
To check the Clinically significant and non clinically significant abnormal values during the course of trial.
Screening up to study completion, an average of 1 year
Incidence of vital sign abnormalities e.g. Systolic and Diastolic BP, Pulse rate.
Time Frame: Screening up to study completion, an average of 1 year
To measure the vital signs on regular basis for all study participants
Screening up to study completion, an average of 1 year
Measure ECG
Time Frame: Screening up to study completion, an average of 1 year
Number of subjects with clinically significant abnormal ECG QT Interval
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
Measure Description
Time Frame
Maximum observed plasma concentration (Cmax) of SHR-1921
Time Frame: Screening up to study completion, an average of 1 year
To check what will be the maximum concentration participants will obtained of SHR-1921 in their blood plasma.
Screening up to study completion, an average of 1 year
Area under the concentration-time curve (AUC 0-∞) from time 0 to infinity of SHR-1921
Time Frame: Screening up to study completion, an average of 1 year
To check the drug profile for absorption, distribution, metabolism and excretion for SHR-1921 in participants blood plasma
Screening up to study completion, an average of 1 year
Time to Cmax (Tmax) of SHR-1921
Time Frame: Screening up to study completion, an average of 1 year
To check what time will it take to reach the maximum contraction of SHR-1921 in study participants
Screening up to study completion, an average of 1 year
Clearance of SHR-1921
Time Frame: Screening up to study completion, an average of 1 year
The apparent clearance of SHR-1921(CL/F) of SHR-1921
Screening up to study completion, an average of 1 year
Terminal elimination half-life (t1/2) of SHR-1921
Time Frame: Screening up to study completion, an average of 1 year
To check how much time SHR-1921 will take to eliminate half of it's concentration from participants.
Screening up to study completion, an average of 1 year
Pharmacodynamics ("ADA" ) of SHR-1921.
Time Frame: Screening up to study completion, an average of 1 year
To check the" Anti Drug Antibody" develops in participants against the SHR-1921 through blood sample
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.
Atridia Pty 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 (Actual)

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 1, 2022

Primary Completion (Actual)

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.
April 24, 2024

Study Completion (Actual)

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.
April 24, 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).
October 18, 2022

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.
October 24, 2022

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.
October 26, 2022

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.
June 25, 2024

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.
June 23, 2024

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.
December 1, 2023

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-102-AUS

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.

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