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

Advanced Solid Tumors Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03544905
• Other study ID #: CYH33-101
• Status: Recruiting
• Phase: Phase 1
• Start date: July 5, 2018
• Est. completion date: March 31, 2024

Study information

• Verified date: January 2023
• Source: Haihe Biopharma Co., Ltd.
• Contact: Ruihua Xu, M.D
• Phone: 86-20-87343804
• Email: ruihxu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• main inclusion:

1. Evidence of a personally signed informed consent document;

2. Male and/or female subjects above the ages of 18 years;

3. Locally advanced or metastatic solid tumor patients who have failed or relapsed on current standard of care for Phase 1a;

4. Subject may provide Tumor tissue section(at least 8 pieces) if they agree;

5. ECOG performance score 0-1;

6. Life expectancy = 12 weeks;

7. At least 1 measurable target lesion on the baseline scan as per RECIST 1.1

Exclusion Criteria:

• main criteria:

1. prior received anti-tumor treatment, including anticancer drugs for the treatment within 28 days of first dose of study treatment;

2. Prior or concomitant other malignant tumor;

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

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)

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Haihe Biopharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MTD(Max tolerance does)	To evaluate the MTD in patients with advanced solid tumor	35 days