A Study of SIM0689 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
SIM0689 for Injection: SIM0689 for Injection is a Programmed Cell Death Protein 1(PD1) / Vascular Endothelial Growth Factor (VEGF) bispecific antibody.
Study summary
This study will evaluate the safety, of SIM0689 and how the body processes it, how it affects the body, and its early signs of activity against tumors when given alone to Adult Participants with Locally Advanced or Metastatic Solid Tumors. The study has a dose escalation part to find the highest dose that can be given safely, or recommended dose (RD) for SIM0689 when given alone, and a dose expansion part in subjects with specific tumor types treated with SIM0689 as a single agent at RD.
Eligibility
Primary outcome measure(s)
- Dose-limiting toxicity (DLT) (Dose escalation) — at the end of Cycle 1 (each cycle is 28 days)
DLTs will be assessed during the dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria. - Maximum tolerated dose (MTD)and / or Recommended dose (RD) (Dose escalation) — Up to approximately 2 years
The MTD is defined as the dose of SIM0689 with an estimated toxicity rate closest to the target toxicity rate of 27%; RD stands for Recommended Dose, which will be selected based on the evaluation of all available pharmacokinetics, pharmacodynamic, efficacy, safety, and tolerability data - Objective Response Rate (ORR) (Dose expansion) — Up to approximately 2 years
ORR is the proportion of participants with complete response(CR)or partial response (PR) assessed according to RECIST v1.1.
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| Fujian Cancer Hospital | Fuzhou | Fujian | Recruiting |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | Not Yet Recruiting |
| Hunan Cancer Hospital | Changsha | Hunan | Not Yet Recruiting |
| The First Hospital of China Medical University | Shenyang | Liaoning | Not Yet Recruiting |
| Cancer Hospital of Shandong First Medical University | Jinan | Shandong | Not Yet Recruiting |
| The First Affiliated Hospital, Zhejiang University school of Medicine | Hangzhou | Zhejiang | Recruiting |
More Jiangsu Simcere Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07660432 on ClinicalTrials.gov ↗ ← All trials in China