A Trial of SHR-4602 Infusion in Patients With SHR-4602 in Subjects With HER2-expressing or HER2-mutated Locally Advanced or Metastatic Solid Tumors

NCT ID: NCT06560138

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-09-12

Brief Summary

To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-4602 in subjects with HER2-expressing or HER2-mutated locally advanced or metastatic solid tumors.

Conditions

HER2-expressing or HER2-mutated Locally or Metastatic Solid Tumors

Study Design

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

Study Groups

SHR-4602 Dose level 1 : 2.0 mg/kg, Dose level 2 : 2.5mg/kg

Group Type: EXPERIMENTAL

SHR-4602

Intervention Type: DRUG

SHR-4602 will be administered through IV infusion.

Interventions

SHR-4602

SHR-4602 will be administered through IV infusion.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.

2. ECOG PS score 0 or 1

3. Life expectancy ≥ 12 weeks

4. Adequate bone marrow and other vital organ functions

5. Adequate liver function tests

6. HER 2 exprission advanced solid tumor

1. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.

2. ECOG PS score 0 or 1

3. Life expectancy ≥ 12 weeks

4. Adequate bone marrow and other vital organ functions

5. Adequate liver function tests

6. HER 2 exprission advanced solid tumor

Exclusion Criteria

1. Active brain metastases, carcinomatous meningitis/leptomeningeal metastases.

2. Have received surgery (eg. major surgerical treatment for cancer), chemotherapy, molecular targeted therapy, immunotherapy, cell therapy, or radiotherapy within 4 weeks prior to the first dose of investigational drug (palliative radiotherapy within 2 weeks prior to the first dose).

3. Participated in another clinical study with the last dose of study drug received in less than 4 weeks prior to the first dose.

4. Subjects with toxicities and/or complications from prior treatment not recovered to NCI-CTCAE Grade ≤ 1.

5. History of pleural fluid, ascites, or pericardial effusion requiring intervention within 2 weeks prior to the first dose.

6. History of active autoimmune diseases.

7. History of hereditary or acquired bleeding disorders or thrombotic tendency

8. Active hepatitis B (defined as hepatitis B virus surface antigen [HBsAg] positive and serum HBV-DNA copy ≥ 500 IU/mL), hepatitis C

9. History of severe infection within the past 30 days, including but not limited to bacteremia, severe sepsis, pneumonia requiring hospitalization

10. Other malignancies currently or within the past 5 years, except for cured cervical carcinoma in situ

11. Allergy to any component or excipient of the SHR-4602 product,

12. History of severe medical, psychiatric, or social conditions deemed by the investigator to be likely to interfere with a subject's ability to understand, consent, cooperate and participate in the study.

13. Patients with Grade≥2 peripheral neuropathy, except for those with mild symptoms that do not require treatment

• 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 Limited

Randwick, New South Wales, Australia

Macquarie University

Sydney, New South Wales, Australia

Icon Cancer Centre South Brisbane

Brisbane, Queensland, Australia

Cancer Research SA

Adelaide, South Australia, Australia

Peninsula & South Eastern Haematology and Oncology Group

Frankston, Victoria, Australia

Countries

Australia

Other Identifiers

SHR-4602-102

Identifier Type: -

Identifier Source: org_study_id