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

NCT05594875 | Completed Phase 1 DMC

• 1 other identifier: SHR-A1921-I-102-AUS
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (4)

• Number of subjects with adverse events (AEs)

  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

  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.

  To measure the vital signs on regular basis for all study participants

  Screening up to study completion, an average of 1 year

• Measure ECG

  Number of subjects with clinically significant abnormal ECG QT Interval

  Screening up to study completion, an average of 1 year

Secondary Outcomes (6)

• Maximum observed plasma concentration (Cmax) of SHR-1921

  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

  Screening up to study completion, an average of 1 year

• Time to Cmax (Tmax) of SHR-1921

  Screening up to study completion, an average of 1 year

• Clearance of SHR-1921

  Screening up to study completion, an average of 1 year

• Terminal elimination half-life (t1/2) of SHR-1921

  Screening up to study completion, an average of 1 year

Study Arms (1)

SHR-1921

EXPERIMENTAL

Drug: SHR-1921

Interventions

SHR-1921 DRUG

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

SHR-1921

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Atridia Pty Ltd.: lead

Study Sites (4)

Scientia Clinical Research

Sydney, New South Wales, 2031, Australia

Location

Macquarie Hospital

Sydney, New South Wales, 2109, Australia

Location

Sydney South West Private Hospital

Sydney, New South Wales, 2170, Australia

Location

ICON Cancer Centre

Brisbane, Queensland, 4101, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR-1921 single arm study in pt. with Advance solid tumors

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 26, 2022
• Study Start: December 1, 2022
• Primary Completion: April 24, 2024
• Study Completion: April 24, 2024
• Last Updated: June 25, 2024

Record last verified: 2023-12

Locations

AU (4)