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Completed

NCT Number: NCT05594875

A Trial 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Macquarie Hospital, Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

SHR-1921

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. Measure ECG

    Time frame: Screening up to study completion, an average of 1 year

    Number of subjects with clinically significant abnormal ECG QT Interval

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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

Sponsors and collaborators

Lead sponsor

Atridia Pty Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 26, 2022
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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