A Phase 1 Study of SSGJ-709 in Patients With Advanced Malignant Tumors

NCT 07016490

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 advanced malignancies.

Intervention / Treatment 

  • Drug: SSGJ-709

Inclusion Criteria:

  • Minimum life expectancy of 3 months;
  • Eastern Cooperative Oncology Group (ECOG) Performance status (PS) score of 0-1;
  • Locally advanced or metastatic malignant tumors confirmed by histopathology or cytology; preferred tumor types for enrollment include head and neck squamous cell carcinoma, non-small cell lung cancer, esophageal squamous cell carcinoma or adenocarcinoma, gastric or gastroesophageal junction adenocarcinoma, colorectal 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 resection 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;

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