To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A13 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).
Age range from 18 to 75 years old (including boundary values), regardless of gender.
Dose escalation and dose expansion stage: Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology and judged by the researcher to be unable to benefit from available standard treatment, or intolerant.
Queue 1: Non-small cell lung cancer (NSCLC) confirmed by histology or cytology, with disease progression and EGFR mutation during or after treatment with third generation TKI and platinum containing therapy.
Queue 2: Breast cancer (BC) confirmed as HER3 positive by histology or cytology after standard treatment failure.
The participant has had other malignant tumors that have not been cured within the past 5 years (excluding malignant tumors that have been clearly cured, such as thyroid cancer, cured basal cell carcinoma of the skin, and cervical carcinoma in situ).
The participant has untreated imaging confirmed central nervous system metastasis.
Meningeal metastases.
Patients with brain metastases who have received systematic or curative brain metastasis treatment (radiotherapy or surgery) in the past, have been confirmed stable by imaging for at least 4 weeks, and have stopped systemic hormone, antiepileptic, convulsive drugs, and other treatments for more than 2 weeks without clinical symptoms can be enrolled.
Shanghai Institute Of Biological Products
Lead sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Collaborator