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

NCT ID: NCT05594875

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2024-04-24

Brief Summary

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

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR-1921

Group Type: EXPERIMENTAL

SHR-1921

Intervention Type: DRUG

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

Interventions

SHR-1921

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atridia Pty Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Scientia Clinical Research

Sydney, New South Wales, Australia

Macquarie Hospital

Sydney, New South Wales, Australia

Sydney South West Private Hospital

Sydney, New South Wales, Australia

ICON Cancer Centre

Brisbane, Queensland, Australia

Countries

Australia

Other Identifiers

SHR-A1921-I-102-AUS

Identifier Type: -

Identifier Source: org_study_id