NCT03544905

Study to Evaluate the Safety, Tolerate, Pharmacokinetics and Preliminary Efficacy of CYH33

A Multi-center, Open-label, Single Arm, Dose Escalation and Dose Extension Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CYH33 in Advanced Solid Tumors Patients.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Haihe Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a Multi-center, Open-label, single arm, Dose Escalation and Dose Extension Phase 1 Study to Evaluate the Safety , Tolerability, Pharmacokinetics and Preliminary Efficacy of CYH33 in Advanced Solid Tumors Patients.

Detailed description

This study includes Phase Ia and Phase Ib. In the dose climbing part of phase Ia, the safety, tolerance and pharmacokinetics characteristics of CYH33 in patients with advanced solid tumors who failed to receive standard treatment, did not tolerate or did not have standard treatment at present will be observed to determine MTD; Before determining MTD, select safe and highly reliable and effective dose levels for simultaneous expansion. Phase Ia dose expansion includes patients with advanced solid tumors who have failed to undergo standard treatment, who are intolerant of PIK3CA gene mutation, or who do not have standard treatment at present, to further evaluate safety, tolerance and initial efficacy. In Phase Ib, the safety and preliminary efficacy of CYH33 on patients with advanced breast cancer, ovarian cancer, endometrial cancer, cervical cancer, head and neck squamous cell carcinoma, esophageal and gastroesophageal junction squamous cell carcinoma, ovarian clear cell carcinoma and other solid tumors with PIK3CA gene mutation who have failed, are intolerant or do not have standard treatment at present will be evaluated.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	CYH33 for tablet	1mg; 5mg; 10mg; 20mg; 30mg; 50mg; 75mg; 100mg; 130mg; 160mg; 200mg; 240mgBID or QD(Decided by SMC accroding to the safty and PK data)

Timeline

• Start date: 2018-07-05
• Primary completion: 2024-12-04
• Completion: 2024-12-04
• First posted: 2018-06-04
• Last updated: 2025-04-22

Locations

30 sites across 1 country: China