Trials / Recruiting
RecruitingNCT07032298
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SSGJ-612 | Intravenous injection |
Timeline
- Start date
- 2025-07-18
- Primary completion
- 2026-04-01
- Completion
- 2026-06-01
- First posted
- 2025-06-23
- Last updated
- 2025-07-25
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07032298. Inclusion in this directory is not an endorsement.