This study is an open-label, dose-escalation and expansion, Phase I clinical study to evaluate the safety, tolerability, PK characteristics and preliminary antitumor activity of WJ47156 monotherapy and in combination with toripalimab in patients with advanced malignant solid tumors. The study consists of two parts, including monotherapy (Part 1) and combination therapy (Part 2).
Male or female, 18 to 75 years old (inclusive) at the time of signing the ICF;
Patients with histologically or cytologically confirmed advanced malignant solid tumors；
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
Life expectancy ≥ 12 weeks;
CNS metastasis；
Pleural effusion, peritoneal effusion or pericardial effusion with clinical symptoms or requiring repeated treatment (e.g., puncture or drainage);
Unable to swallow tablets, intestinal obstruction, or other factors affecting the administration and gastrointestinal absorption of tablets
Having received chemotherapy, immunotherapy or other anti-tumor therapy or other investigational drug within 21 days prior to the first dose, or having received oral fluorouracil, small-molecule targeted drugs or Chinese herbal products for antitumor indications within 14 days prior to the first dose;
Shanghai Junshi Bioscience Co., Ltd.
Lead sponsor
Sponsor GmbH
Collaborator