An Open-label Phase Ib, Study, to Determine Safety of Oral AL3810 in Patients With Locally Advanced or Metastatic Gastric, Hepatocellular or Nasopharyngeal Carcinoma
Overview
- Phase
- Phase 1
- Intervention
- AL3810
- Conditions
- Advanced Solid Tumor
- Sponsor
- Haihe Biopharma Co., Ltd.
- Enrollment
- 60
- Locations
- 6
- Primary Endpoint
- AE
- Last Updated
- 8 years ago
Overview
Brief Summary
This project intends to make a study of personalized medicine evaluation system establishment for liver cancer, gastric cancer and nasopharynx cancer to provide strong support for the development of Precision Medicine and personalized medicine for the patients of high-incidence-rates cancer in China.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
gastric carcinoma
20 gastric carcinoma patients were randomly divided into two groups: 4W on or 3w on/1w off, oral AL3810
Intervention: AL3810
hepatocellular carcinoma
20 hepatocellular carcinoma patients were randomly divided into two groups: 4W on or 3w on/1w off, oral AL3810
Intervention: AL3810
Nasopharyngeal carcinoma
20 Nasopharyngeal carcinoma patients were randomly divided into two groups: 4W on or 3w on/1w off, oral AL3810
Intervention: AL3810
Outcomes
Primary Outcomes
AE
Time Frame: through study completion, an average of 1 year
the number of patients with grade 3 and 4 AE according to CTC AE 4.03
Secondary Outcomes
- ORR(through study completion, an average of 1 year)
- AUC(up to 3 cycles(28 days/cycle))
- Cmax(up to 3 cycles(28 days/cycle))
- DoR(through study completion, an average of 1 year)
- DCR(through study completion, an average of 1 year)
- PFS(through study completion, an average of 1 year)