Clinical trial · Interventional
A Phase I Study of SSGJ-612 in Patients With Advanced Solid Tumors
Phase I Clinical Study on the Safety, Pharmacokinetics and Antitumor Activity of SSGJ-612 in Patients With Advanced Solid Tumors
NCT07032298CI-TRIAL-00092604recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Tumors | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SSGJ-612 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SSGJ-612
- description
- 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.
- interventionNames
- Drug: SSGJ-612
Primary outcomes (2)
- measure
- Incidence and severity of Adverse Events (AEs)
- timeFrame
- Through study completion, an average of 1 year
- description
- 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.
- measure
- Incidence of DLT
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.