Brief Summary
This study is an open-label phase I study to evaluate the safety, pharmacokinetics, and anti-tumor activity of SSGJ-709 as a single agent in patients with advancedat a late stage, far along malignancies.
Intervention / Treatment
- Drug: SSGJ-709
Inclusion Criteria:
- Minimum life expectancy of 3 months;
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) Performance status (PS) score of 0-1;
- Locally advanced or metastatic malignantcancerous, may grow and spread to other areas of the body tumors confirmed by histopathology or cytology; preferred tumor types for enrollment include head and neck squamous cell carcinomacancer arising from tissues that line organs, non-small cell lung cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs, esophageal squamous cell carcinoma or adenocarcinomacancer arising from mucus-producing glands in organs, gastric or gastroesophageal junction adenocarcinoma, colorectalrelating to the colon or rectum in the large bowel/intestine adenocarcinoma, hepatocellular carcinoma, urothelial carcinoma, and clear cell renal cell carcinoma. Subjects with other tumor types may be enrolled after discussion with the sponsor；
- Subject who have failed, or has been intolerant to standard therapy, or has been considered lack standard of care for a given tumor type, and who is not able to complete surgical resectionsurgical removal of tissue or part/all of an organ and receive curative concurrent/sequential chemoradiotherapy；
- Having at least one measurable tumor lesion as the target lesion assessed per RECIST v1.1；
- The subject has adequate hematological and organ functions；