Trials / Recruiting
RecruitingNCT07348211
First in Human Study of SIM0610 in Solid Tumors
An Open-Label, Multicenter, First-in-Human Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SIM0610 in Adult Subjects With Locally Advanced/Metastatic Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 260 (estimated)
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, open-label, first-in-human (FIH) study to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic profile, and preliminary antitumor activity of SIM0610 in subjects with locally advanced/metastatic solid tumors. Accelerated titration (ATD) and Bayesian optimal interval design (BOIN) will be used to guide dose escalation in part1, the preliminary anti-tumor effect of SIM0610 will to be further evaluated in part 2.
Conditions
- Advanced Solid Tumours
- Non-Small Cell Lung Cancer
- Colorectal Cancer
- Head and Neck Squamous Cell Carcinoma
- Hepatocellular Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SIM0610 for Injection | intravenous infusion |
| DRUG | SIM0610 for Injection | intravenous infusion |
Timeline
- Start date
- 2026-01-19
- Primary completion
- 2027-12-01
- Completion
- 2029-07-01
- First posted
- 2026-01-16
- Last updated
- 2026-01-23
Locations
7 sites across 1 country: China
Source: ClinicalTrials.gov record NCT07348211. Inclusion in this directory is not an endorsement.