Advanced Malignant Tumors
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGSSGJ-612
Intravenous injection
Sponsors
Shenyang Sunshine Pharmaceutical Co., LTD.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily participate in this study, be willing to follow and complete all trial procedures, and sign the informed consent form; 2. Aged ≥18 and ≤75 years old at the time of signing the ICF, regardless of gender; 3. Expected survival ≥3 months; 4. Performance status (PS) score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale; 5. Patients with pathologically or cytologically confirmed locally advanced or metastatic malignant tumors who have failed standard treatment, are intolerant to standard treatment, or have no standard treatment available, and cannot undergo complete surgical resection or receive radical concurrent/sequential chemoradiotherapy; 6. Tumor tissue with HER2 expression; 7. At least one measurable tumor lesion assessed as the target lesion according to RECIST v1.1 criteria, and the lesion is suitable for repeated and accurate measurement.
Exclusion criteria
1. Presence of brainstem, meninges, or spinal cord metastasis, or spinal cord compression; 2. Presence of active central nervous system (CNS) metastatic lesions; 3. Individuals with clinical symptoms or requiring repeated drainage (once a month or more frequently) of pleural effusion, pericardial effusion, or ascites; 4. Primary or secondary immunodeficiency, including positive human immunodeficiency virus (HIV) test; 5. Known active tuberculosis; known active syphilis infection; 6. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 7. Use of any live vaccine or attenuated live vaccine within 4 weeks before the first dose, or plan to receive any live vaccine or attenuated live vaccine during the study; 8. Known severe allergic history to any component of the investigational drug, or history of severe allergic reaction to antibodies; 9. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of Adverse Events (AEs) | Through study completion, an average of 1 year | 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. |
| Incidence of DLT | 14 days | Dose-Limiting Toxicity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DCR assessed by investigators per RECIST v1.1 | Through study completion, an average of 1 year | Disease Control Rate (DCR) is the proportion of patients with CR, PR, and Stable Disease (SD), assessed by investigators per RECIST v1.1. |
| TTR assessed by investigators per RECIST v1.1 | Through study completion, an average of 1 year | 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). |
| PFS | Through study completion, an average of 1 year | 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. |
| OS | Through study completion, an average of 1 year | Overall Survival (OS) is defined as the time from the start of treatment with SSGJ-612 until death due to any cause. |
| Cmax of SSGJ-612 | Through study completion, an average of 1 year | Peak concentration (Cmax), in single dose period and multiple dose periods. |
| ORR assessed by investigators per RECIST v1.1 | Through study completion, an average of 1 year | Objective Response Rate (ORR) is the proportion of patients with Complete Response (CR) or Partial Response (PR), assessed by investigators per RECIST v1.1. |
| Tmax of SSGJ-612 | Through study completion, an average of 1 year | Peak time (Tmax), in single dose period and multiple dose periods. |
| T1/2 of SSGJ-612 | Through study completion, an average of 1 year | Elimination phase half-life (T1/2), in single dose period and multiple dose periods. |
| AUC0-last | Through study completion, an average of 1 year | Area under plasma concentration-time curve from 0 to the last quantifiable time point (AUC0-t), in single dose period and multiple dose periods. |
| Incidence of ADA and Nab | Through study completion, an average of 1 year | Number of patients with detectable Anti-drug Antibody (ADA) and Neutralizing Antibodies (NAb). |
| The correlation between HER2 expression and efficacy | Through study completion, an average of 1 year | The correlation between expression level of HER2 in tumor tissues and anti-tumor activity. |
| Cmin of SSGJ-612 | Through study completion, an average of 1 year | Trough concentration (Cmin), in multiple dose periods. |
| DoR assessed by investigators per RECIST v1.1 | Through study completion, an average of 1 year | 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. |
Countries
China
Contacts
Primary ContactJun Yao, M.D.
Backup ContactCai'e Wang, M.D.
Outcome results
None listed