NCT03994484

Study of Dosage Exploration and Pharmacokinetics for HA121-28 Tablets

Pharmacokinetics of Single and Multiple Doses of HA121-28 Tablets and Exploration of Maximum Tolerated Dose in Patients With Advanced Solid Tumor in PhaseⅠClinical Trial

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

There are 2 phases in this study: Phase 1 (dose escalation) and Phase 2 (dose expansion). The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of HA121-28 tablets that can be given to patients with advanced cancer. The goal of Phase 2 of this study is to learn if the dose of HA121-28 tablets found in Phase 1 can help to control advanced cancer. The safety of HA121-28 tablets will be studied in both phases of the study.

Detailed description

If participants are found to be eligible to take part in this study, they will be assigned to a study group based on when they join this study. Up to 8 groups of up to 20 participants will be enrolled in Phase 1 of the study, and up to 3 groups of up to 24 participants will be enrolled in Phase 2. If participant is enrolled in Phase 1, the dose of HA121-28 tablets they receive will depend on when they join this study. The first group of participants will receive the lowest dose level of HA121-28 tablets. Each new group will receive a higher dose of HA121-28 tablets than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of HA121-28 tablets is found. If participant is enrolled in Phase 2, they will receive HA121-28 tablets at the low, medium and high doses to select the recommended dose for phase Ⅱ clinical trials.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	HA121-28 tablets	Participants will receive oral HA121-28 at a starting dose of 25 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
DRUG	HA121-28 tablets	Participants will receive oral HA121-28 at a dose of 50 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
DRUG	HA121-28 tablets	Participants will receive oral HA121-28 at a dose of 100 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
DRUG	HA121-28 tablets	Participants will receive oral HA121-28 at a dose of 200 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
DRUG	HA121-28 tablets	Participants will receive oral HA121-28 at a dose of 300 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
DRUG	HA121-28 tablets	Participants will receive oral HA121-28 at a dose of 450 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
DRUG	HA121-28 tablets	Participants will receive oral HA121-28 at a dose of 600 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
DRUG	HA121-28 tablets	Participants will receive oral HA121-28 at a dose of 800 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle

Timeline

• Start date: 2018-10-10
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2019-06-21
• Last updated: 2022-02-10

Locations

1 site across 1 country: China