SHR-4602-102
An Open-label, Multi-center Phase I Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-4602 in Subjects With HER2-expressing or HER2-mutated Locally Advanced or Metastatic Solid Tumors
Trial 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.
Receptor status / problem studied:
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.
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
Trial Title
SHR-4602-102
Diagnosis
Advanced solid tumours
Type of trial
Pharmaceutical
Type of treatement
Medical Oncology
Phase
I