Status:
WITHDRAWN
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
Lead Sponsor:
Atridia Pty Ltd.
Conditions:
HER2-expressing or HER2-mutated Locally or Metastatic Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
- ECOG PS score 0 or 1
- Life expectancy ≥ 12 weeks
- Adequate bone marrow and other vital organ functions
- Adequate liver function tests
- HER 2 exprission advanced solid tumor
Exclusion
- Inclusion Criteria
- Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
- ECOG PS score 0 or 1
- Life expectancy ≥ 12 weeks
- Adequate bone marrow and other vital organ functions
- Adequate liver function tests
- HER 2 exprission advanced solid tumor
- Exclusion Criteria
- Active brain metastases, carcinomatous meningitis/leptomeningeal metastases.
- 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).
- Participated in another clinical study with the last dose of study drug received in less than 4 weeks prior to the first dose.
- Subjects with toxicities and/or complications from prior treatment not recovered to NCI-CTCAE Grade ≤ 1.
- History of pleural fluid, ascites, or pericardial effusion requiring intervention within 2 weeks prior to the first dose.
- History of active autoimmune diseases.
- History of hereditary or acquired bleeding disorders or thrombotic tendency
- Active hepatitis B (defined as hepatitis B virus surface antigen \[HBsAg\] positive and serum HBV-DNA copy ≥ 500 IU/mL), hepatitis C
- History of severe infection within the past 30 days, including but not limited to bacteremia, severe sepsis, pneumonia requiring hospitalization
- Other malignancies currently or within the past 5 years, except for cured cervical carcinoma in situ
- Allergy to any component or excipient of the SHR-4602 product,
- 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.
- Patients with Grade≥2 peripheral neuropathy, except for those with mild symptoms that do not require treatment
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06560138
Start Date
March 1 2025
End Date
September 12 2026
Last Update
January 7 2025
Active Locations (5)
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1
Scientia Clinical Research Limited
Randwick, New South Wales, Australia, 2031
2
Macquarie University
Sydney, New South Wales, Australia, 2109
3
Icon Cancer Centre South Brisbane
Brisbane, Queensland, Australia, 4101
4
Cancer Research SA
Adelaide, South Australia, Australia, 500