Brief Summary
This is a multicentre, open-label, first-in-human, phase 1/2 study of IBI133 in subjects with unresectable, locally advancedat a late stage, far along or metastatic solid tumours. Phase 1 section includes three parts, IBI133 dosethe amount of medication taken escalation part, and IBI133 monotherapy dose expansion part. The objective of phase 1 section is to identify MTD/recommended dose for expansion (RDE) of IBI133 monotherapy . The objective of phase 2 section is to further explore efficacy, safety and tolerability of IBI133 monotherapy at RDE in specified tumoura tissue mass that forms from groups of unhealthy cells population. The treatment cycle of the study is defined as every 3 weeks (21 days).
Intervention / Treatment
- Biological: IBI133
Inclusion Criteria:
- Subjects with the ability to understand and give written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. for participation in this trial, including all evaluations and procedures as specified by this protocol;
- Male or female subjects ≥ 18 years old;
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status (PS) of 0 or 1;
- Anticipated life expectancy of ≥ 12 weeks;
- Adequate bone marrowsoft, spongy tissue found in bones that makes blood cells and organ function.
- Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumour that is refractory to or intolerable with standard treatment, or for which no standard treatment is available;