Eligible patients must have HER2-positive (IHC 3+/ISH+) advanced breast/gastric cancer unamenable to standard therapy, measurable lesions (RECIST 1.1), ECOG 0-1, adequate organ function, and anthracycline exposure below doxorubicin-equivalent 360mg/m2. Exclusions cover active HBV/HCV/HIV, uncontrolled infections, severe cardiopulmonary diseases (NYHA ≥2, CHF, recent MI), symptomatic CNS metastases, or Grade ≥2 neuropathy.

This trial was conducted in subjects with histologically confirmed HER2-positive breast cancer (having evaluable lesions and an Eastern Cooperative Oncology Group performance status of 0 or 1) using a 3 + 3 design of escalating BAT8001 doses. Patients received BAT8001 intravenously in a 21-day cycle, with dose escalation in 5 cohorts: 1.2, 2.4, 3.6, 4.8, and 6.0 mg/kg. The primary objective was to evaluate the safety and tolerability of BAT8001. Preliminary activity of BAT8001 was also assessed as a secondary objective.

Primary safety endpoints include dose-limiting toxicity (DLT) criteria spanning hematologic, hepatic, cardiac (e.g., LVEF ≤45% with ≥10% decrease) and other organ toxicities (Grade ≥3) assessed over 21 days post-dose. Pharmacokinetic parameters (AUC, Cmax, t1/2) of BAT8001, total antibody, and batansine are evaluated during Cycles 1-4 (21-day cycles), alongside immunogenicity monitoring (ADA/NADA). Maximum tolerated dose (MTD) is determined when ≤1/6 patients experience DLT.

Eligible patients must have HER2-positive (IHC 3+/ISH+) advanced breast/gastric cancer unamenable to standard therapy, measurable lesions (RECIST 1.1), ECOG 0-1, adequate organ function, and anthracycline exposure below doxorubicin-equivalent 360mg/m2. Exclusions cover active HBV/HCV/HIV, uncontrolled infections, severe cardiopulmonary diseases (NYHA ≥2, CHF, recent MI), symptomatic CNS metastases, or Grade ≥2 neuropathy.

This trial was conducted in subjects with histologically confirmed HER2-positive breast cancer (having evaluable lesions and an Eastern Cooperative Oncology Group performance status of 0 or 1) using a 3 + 3 design of escalating BAT8001 doses. Patients received BAT8001 intravenously in a 21-day cycle, with dose escalation in 5 cohorts: 1.2, 2.4, 3.6, 4.8, and 6.0 mg/kg. The primary objective was to evaluate the safety and tolerability of BAT8001. Preliminary activity of BAT8001 was also assessed as a secondary objective.

Primary safety endpoints include dose-limiting toxicity (DLT) criteria spanning hematologic, hepatic, cardiac (e.g., LVEF ≤45% with ≥10% decrease) and other organ toxicities (Grade ≥3) assessed over 21 days post-dose. Pharmacokinetic parameters (AUC, Cmax, t1/2) of BAT8001, total antibody, and batansine are evaluated during Cycles 1-4 (21-day cycles), alongside immunogenicity monitoring (ADA/NADA). Maximum tolerated dose (MTD) is determined when ≤1/6 patients experience DLT.

Inclusion criteria require HER2-positive breast cancer (IHC 3+/FISH+), prior taxane/trastuzumab therapy, measurable lesions (RECIST 1.1), ECOG 0-1, LVEF ≥50%, and contraception for participants of childbearing potential. Exclusion criteria include grade ≥2 neuropathy, active brain metastases, unresolved radiation toxicity, severe cardio-pulmonary diseases, recent myocardial infarction, uncontrolled systemic illness, malabsorption disorders, or intolerance to trastuzumab.

Eligible patients (18-75 years) must have HER2-positive advanced solid tumors (IHC 3+/ISH+) with ECOG 0-1, measurable lesions (RECIST 1.1), and adequate organ function. Exclusions include recent anti-tumor therapy (≤4 weeks), uncontrolled CNS metastases, active autoimmune diseases, severe cardiovascular conditions, or prior anthracycline overdose (doxorubicin >360mg/m2 equivalent).