A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors

The subjects with locally advanced or metastatic G/GEJ adenocarcinoma who are supposed to be enrolled into the combination therapy cohorts with CAPOX and CAPOX+nivolumab (Cohort C and G) have previously received systemic chemotherapy; and the subjects in the Cohort G have previously received PD1/PD-L1/CTLA4 antibody treatment. The subjects will be eligible provided that they have completed neoadjuvant or adjuvant chemotherapy at least 6 months prior to the initial dosing of the study; The subjects with locally advanced or metastatic G/GEJ adenocarcinoma who are supposed to be enrolled into the combination therapy cohort with paclitaxel (Cohort D) have previously received taxane drugs.

The subjects who previously received radiotherapy within 4 weeks prior to the initial dosing of the investigational drug (the subjects who previously received local radiotherapy for bone metastases treatment within 4 weeks with the radiotherapy related AE resolved to ≤ Grade 1 will be eligible);

The subjects who previously received other systematic anti-tumor drug therapies within 4 weeks or 5 half-lives prior to the initial dosing of the investigational drug (whichever is shorter); The medication (such as zoledronic acid) for bone metastases related events will not influence on the enrollment;

The subjects who previously received major surgery (exclusive of aspiration biopsy) within 8 weeks prior to the initial dosing of the investigational drug, or who are expected to undergo major surgery, or who are in the conditions such as severe unhealed wound, trauma, and ulcer;