A Phase 1 Study of SSGJ-709 in Patients With Advanced Malignant Tumors
ConditionAdvanced Malignant Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShenyang Sunshine Pharmaceutical Co., LTD.
About this trial
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.
Eligibility criteria
Qualifiers
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；
Disqualifiers
Presence of brainstem, meningeal metastases, spinal cord metastases or compression；
Presence of active central nervous system (CNS) metastases；
Subjects with pleural effusion, pericardial effusion, or ascites that are clinically symptomatic or require repeated drainage；
Subjects with other malignant tumors within 3 years prior to screening；
Trial design
Treatments tested in this trial
- SSGJ-709
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Shenyang Sunshine Pharmaceutical Co., LTD.
Lead sponsor
Macquarie University, Australia
Collaborator
Source ClinicalTrials.gov