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

Primary Purpose

Advanced Solid Tumor

Status
Recruiting
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
SHR-1921
Sponsored by
Atridia Pty Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Scientia Clinical ResearchRecruiting
  • Macquarie Hospital
  • Sydney South West Private Hospital
  • ICON Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SHR-1921

Arm Description

Outcomes

Primary Outcome Measures

Number of subjects with adverse events (AEs)
To check the numbers of AEs happened during the course of trial.
Number of subjects with laboratory tests findings of potential clinical importance
To check the Clinically significant and non clinically significant abnormal values during the course of trial.
Incidence of vital sign abnormalities e.g. Systolic and Diastolic BP, Pulse rate.
To measure the vital signs on regular basis for all study participants
Measure ECG
Number of subjects with clinically significant abnormal ECG QT Interval

Secondary Outcome Measures

Maximum observed plasma concentration (Cmax) of SHR-1921
To check what will be the maximum concentration participants will obtained of SHR-1921 in their blood plasma.
Area under the concentration-time curve (AUC 0-∞) from time 0 to infinity of SHR-1921
To check the drug profile for absorption, distribution, metabolism and excretion for SHR-1921 in participants blood plasma
Time to Cmax (Tmax) of SHR-1921
To check what time will it take to reach the maximum contraction of SHR-1921 in study participants
Clearance of SHR-1921
The apparent clearance of SHR-1921(CL/F) of SHR-1921
Terminal elimination half-life (t1/2) of SHR-1921
To check how much time SHR-1921 will take to eliminate half of it's concentration from participants.
Pharmacodynamics ("ADA" ) of SHR-1921.
To check the" Anti Drug Antibody" develops in participants against the SHR-1921 through blood sample

Full Information

First Posted
October 18, 2022
Last Updated
January 2, 2023
Sponsor
Atridia Pty Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05594875
Brief Title
A Trial of SHR-A1921 for Injection in Subjects With Advanced Solid Tumors
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atridia Pty Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
SHR-1921 single arm study in pt. with Advance solid tumors
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SHR-1921
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SHR-1921
Intervention Description
Subject will receive a single dose of SHR-1921 at dose level 1/2/3 on Day of each cycles
Primary Outcome Measure Information:
Title
Number of subjects with adverse events (AEs)
Description
To check the numbers of AEs happened during the course of trial.
Time Frame
Screening up to study completion, an average of 1 year
Title
Number of subjects with laboratory tests findings of potential clinical importance
Description
To check the Clinically significant and non clinically significant abnormal values during the course of trial.
Time Frame
Screening up to study completion, an average of 1 year
Title
Incidence of vital sign abnormalities e.g. Systolic and Diastolic BP, Pulse rate.
Description
To measure the vital signs on regular basis for all study participants
Time Frame
Screening up to study completion, an average of 1 year
Title
Measure ECG
Description
Number of subjects with clinically significant abnormal ECG QT Interval
Time Frame
Screening up to study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax) of SHR-1921
Description
To check what will be the maximum concentration participants will obtained of SHR-1921 in their blood plasma.
Time Frame
Screening up to study completion, an average of 1 year
Title
Area under the concentration-time curve (AUC 0-∞) from time 0 to infinity of SHR-1921
Description
To check the drug profile for absorption, distribution, metabolism and excretion for SHR-1921 in participants blood plasma
Time Frame
Screening up to study completion, an average of 1 year
Title
Time to Cmax (Tmax) of SHR-1921
Description
To check what time will it take to reach the maximum contraction of SHR-1921 in study participants
Time Frame
Screening up to study completion, an average of 1 year
Title
Clearance of SHR-1921
Description
The apparent clearance of SHR-1921(CL/F) of SHR-1921
Time Frame
Screening up to study completion, an average of 1 year
Title
Terminal elimination half-life (t1/2) of SHR-1921
Description
To check how much time SHR-1921 will take to eliminate half of it's concentration from participants.
Time Frame
Screening up to study completion, an average of 1 year
Title
Pharmacodynamics ("ADA" ) of SHR-1921.
Description
To check the" Anti Drug Antibody" develops in participants against the SHR-1921 through blood sample
Time Frame
Screening up to study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathy You
Phone
: +61 02 9299 043
Email
kathyyou@atridia.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ravi Patel
Phone
+61 0452363506
Email
ravi.patel@atridia.com
Facility Information:
Facility Name
Scientia Clinical Research
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Lemech, Dr
Phone
0293825800
Email
charlotte.lemech@scientiaclinicalresearch.com.au
Facility Name
Macquarie Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Park, Dr
Phone
0298122956
Email
john.park@mqhealth.org.au
Facility Name
Sydney South West Private Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Cooper, Dr
Phone
0423702208
Email
Adam.Cooper@health.nsw.gov.au
Facility Name
ICON Cancer Centre
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jermaine Coward, Dr
Phone
073737473
Email
jim.coward@icon.team

12. IPD Sharing Statement

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

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