Trials / Recruiting
RecruitingNCT07390838
A Study of SH009 Injection in Patients With Advanced Solid Tumors.
An Open, Multicenter, Phase I Clinical Study on the Safety, Efficacy, and Pharmacokinetics of SH009 Injection in Patients With Advanced Solid Tumors.
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Evaluate the efficacy and safety of SH009 injection therapy for patients with advanced solid tumors
Detailed description
Based on the obtained data from the dose escalation phase of the Phase I clinical trial, select safe and effective tumor indications (including but not limited to gastric cancer, liver cancer, head and neck tumors, breast cancer, non-small cell lung cancer, esophageal cancer, etc.) and dose levels for dose expansion studies. Further evaluate efficacy, safety, and pharmacokinetics to provide a basis for determining the recommended dose for Phase II clinical trials.
Conditions
- Liver Cancer (Locally Advanced or Metastatic)
- Lung Cancer (NSCLC)
- Head and Neck Cancer Squamous Cell Carcinoma
- Breast Cancer (Locally Advanced or Metastatic)
- Esophageal Cancer
- Gastric Cancer (GC)
- Solid Tumor Malignancies
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SH009 | The dosage of SH009 is 40 mg/kg QW with a treatment cycle of 28 days |
Timeline
- Start date
- 2025-05-16
- Primary completion
- 2026-12-30
- Completion
- 2028-12-30
- First posted
- 2026-02-05
- Last updated
- 2026-02-05
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07390838. Inclusion in this directory is not an endorsement.