NCT04360317

Safety of the Combination of SH003 and Docetaxel in Patients With Solid Cancer

Phase I Study to Evaluate the Maximum Tolerated Dose of the Combination of SH003 and Docetaxel in Patients With Solid Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Kyunghee University Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The study is designed as a single Group, Dose Elevating trial which evaluates safety to confirm the final maximum tolerated dose by the combination of oral administration of SH003 to docetaxel administered patients. Firstly, 3 subjects is recruited and administered for 21 days for the starting dose of 2,400 mg / day. If no DLT occurs, raise the dose to a secondary dose of 3,600 mg / day. If DLT occurs, additional 3 subjects are recruited and administered for 2,400mg / day. After, If two or more of the six subjects shows DLT, stop the capacity increase, whereas if DLT occurs in less than 1 person, increase the dose to 3,600 mg / day. Next, 3 subjects is recruited and administered for 21 days for a dose of 3,600 mg / day. If no DLT occurs, raise the dose to 4,800 mg / day. If DLT occurs, 3 subjects are additionally recruited and administered for 3,600 mg / day. After, If two or more of the six subjects shows DLT, stop the capacity increase, whereas if DLT occurs in less than 1 person, increase the dose to 4,800 mg / day. Finally, 3 subjects is recruited and administered for a dose of 4,800 mg / day. If no DLT occurs, complete the study. If DLT occurs, additional 3 subjects are recruited and administered for 4,800mg / day and complete the study after observation.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Combination of SH003 and Docetaxel	Combination of SH003 and Docetaxel

Timeline

• Start date: 2020-06-01
• Primary completion: 2021-05-01
• Completion: 2021-08-01
• First posted: 2020-04-24
• Last updated: 2020-04-24