This is a first-in-human, 2-part study to investigate the safety, tolerability, pharmacokinetics and efficacy of KM257 by itself and combined with selected chemotherapy agents in patients with advanced HER2-positive or expressing cancers.
Able to understand, voluntarily participate and willing to sign the ICF.
Male or female subject >= 18 years and =<75 years.
Histologically or cytologically confirmed advanced solid tumors.
HER2 positive or expressing.
primary CNS tumors (including meningeal tumors), symptomatic or untreated CNS metastases(including meningeal metastases).
Subjects who had other malignancies in the 2 years prior to the first administration of the investigational drug were excluded in Phase Ib, except those who had basal cell carcinoma, breast cancer in situ, or cervical cancer in situ and had no recurrence and metastasis after radical therapy.
Accepted any other anti-tumor drug therapies within 2 weeks before first dose.
Accepted major surgery or radical radiotherapy within 4 weeks before first dose; Accepted palliative radiotherapy within 2 weeks before first dose; Accepted radioactive agents(strontium, samarium, etc.)for therapeutic purposes within 8 weeks before first dose.