Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-24 @ 11:53 AM
NCT ID:
NCT06202261
Eligibility Criteria:
Inclusion Criteria:
* Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0\~1; The expected survival is over 3 months.
* Phase Ib
1. Advanced malignancies confirmed by cytology / histopathology, priority given to subjects with HER2 expression or amplification;
2. Subjects with malignant tumors who have failed standard treatment or lack effective treatment;
3. Confirmed presence of at least one evaluable lesion according to RECIST 1.1 criteria
* Phase II
1. Hormone receptor (HR)-negative, HER2-positive breast cancer confirmed by cytology / histopathology, with evidence of local recurrence or distant metastasis, unsuitable for surgery or radiotherapy for curative purposes:
2. Have not received systemic antitumor therapy for metastatic stage; Systemic use of endocrine therapy is permitted, but not exceed 2 lines;
3. at least one measurable lesion that meets the RECIST 1.1 criteria.
* Major organs are functioning normally.
* Female subjects of reproductive age should agree to use contraceptive methods during the study period and until 6 months after the end of the study; Negative serum pregnancy / urine pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects; Male subjects should agree to use contraception during the study and until six months after the end of the study.
Exclusion Criteria:
* Have occured other malignant tumors within 3 years prior to first dose.
* Unalleviated toxicity above Common Terminology Criteria for Adverse Events (CTCAE) grade 1 due to any prior treatment;
* Received major surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the first dose;
* Long-term unhealed wounds or fractures;
* Arterial/venous thrombosis events occurred within 6 months before the first dose;
* Have a history of psychotropic drug abuse and can't get rid of it or have mental disorders;
* Subject with any severe and/or uncontrolled disease;
* Subjects who have been treated with other antitumor agents such as chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first dose, within 5 half-lives of the drug;
* Have used traditional chinese medicine with anti-tumor indications approved by National Medical Products Administration (NMPA) within 2 weeks before the first dose;
* Severe bone injury due to bone metastasis;
* Subjects with untreated active brain metastases or meningeal metastases or cancerous meningitis;
* In the course of previous HER2-targeted therapy, Left Ventricular Ejection Fractions (LVEF) decreased to \<50% or absolute LVEF decreased \>15%;
* Cumulative doses of anthracyclines exceeded doxorubicin or doxorubicin liposomes \>360 mg/m2;
* Uncontrolled hypercalcemia or symptomatic hypercalcemia requires continued bisphosphonate therapy
* Patients with severe hypersensitivity after the use of monoclonal antibodies;
* Has participated in other antitumor clinical trials within 4 weeks prior to the first dose.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06202261
Study Brief:
Protocol Section:
NCT06202261