A Phase 1 interventional study of SSGJ-612 in Advanced Malignant Tumors, sponsored by Shenyang Sunshine Pharmaceutical Co., LTD.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-07-25.
Sponsored by Shenyang Sunshine Pharmaceutical Co., LTD. · Phase 1, Interventional, and Treatment
This study is an open-label phase I study to evaluate the safety, pharmacokinetics, and antitumor activity of SSGJ-612 in patients with advanced malignant solid tumors expressing HER2.
The clinical trial consists of two phases. In the dose escalation stage, the accelerated titration method combined with the traditional "3+3" design will be adopted, to evaluate the safety and dose-limiting toxicity (DLT), and to determine the maximum tolerated dose (MTD) or the maximum dose of administration (MAD). In the dose expansion phase, several safe and effective dose levels of SSGJ-612 will be expanded and further evaluated in larger groups of participants.
Shenyang Sunshine Pharmaceutical Co., LTD. is the lead sponsor of 39 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In dose escalation phase, participants will receive one of the five increasing dose levels of SSGJ-612 respectively, intravenously (IV). During or after dose escalation, any dose levels that does not exceed the MTD can be expanded.
Drug: SSGJ-612
Intravenous injection
Incidence and severity of Adverse Events (AEs)
Adverse Events (AEs) refers to all adverse medical events that occur in patients after they receive the investigational drug and do not necessarily have a causal relationship with the investigational drug. AEs were evaluated according to CTCAE V5.0.
Time frame: Through study completion, an average of 1 year
Incidence of DLT
Dose-Limiting Toxicity
Time frame: 14 days
ORR assessed by investigators per RECIST v1.1
Objective Response Rate (ORR) is the proportion of patients with Complete Response (CR) or Partial Response (PR), assessed by investigators per RECIST v1.1.
Time frame: Through study completion, an average of 1 year
DoR assessed by investigators per RECIST v1.1
Duration of Response (DoR) is the time between the first onset of CR or PR and the first onset of Disease Progression (PD) (assessed by investigators per RECIST v1.1) or death from any cause.
Time frame: Through study completion, an average of 1 year
DCR assessed by investigators per RECIST v1.1
Disease Control Rate (DCR) is the proportion of patients with CR, PR, and Stable Disease (SD), assessed by investigators per RECIST v1.1.
Time frame: Through study completion, an average of 1 year
TTR assessed by investigators per RECIST v1.1
Time to Response (TTR) is the time from the start of treatment until the date of first documented response (assessed by investigators per RECIST v1.1).
Time frame: Through study completion, an average of 1 year
PFS
Progression-Free Survival (PFS) is the time between first initiation of study treatment to PD (assessed by investigators per RECIST v1.1) or death due to any reason.
Time frame: Through study completion, an average of 1 year
OS
Overall Survival (OS) is defined as the time from the start of treatment with SSGJ-612 until death due to any cause.
Time frame: Through study completion, an average of 1 year
Cmax of SSGJ-612
Peak concentration (Cmax), in single dose period and multiple dose periods.
Time frame: Through study completion, an average of 1 year
Cmin of SSGJ-612
Trough concentration (Cmin), in multiple dose periods.
Time frame: Through study completion, an average of 1 year
Tmax of SSGJ-612
Peak time (Tmax), in single dose period and multiple dose periods.
Time frame: Through study completion, an average of 1 year
T1/2 of SSGJ-612
Elimination phase half-life (T1/2), in single dose period and multiple dose periods.
Time frame: Through study completion, an average of 1 year
AUC0-last
Area under plasma concentration-time curve from 0 to the last quantifiable time point (AUC0-t), in single dose period and multiple dose periods.
Time frame: Through study completion, an average of 1 year
Incidence of ADA and Nab
Number of patients with detectable Anti-drug Antibody (ADA) and Neutralizing Antibodies (NAb).
Time frame: Through study completion, an average of 1 year
The correlation between HER2 expression and efficacy
The correlation between expression level of HER2 in tumor tissues and anti-tumor activity.
Time frame: Through study completion, an average of 1 year
Plan to share: No
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Shenyang Sunshine Pharmaceutical Co., LTD.