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.

Haihe Biopharma Co., Ltd.30 sites in 1 country206 target enrollmentJuly 5, 2018

ConditionsAdvanced Solid Tumors

InterventionsCYH33 for tablet

DrugsCYH33 for tablet

Overview

Phase: Phase 1
Intervention: CYH33 for tablet
Conditions: Advanced Solid Tumors
Sponsor: Haihe Biopharma Co., Ltd.
Enrollment: 206
Locations: 30
Primary Endpoint: MTD(Max tolerance does)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 5, 2018

End Date

December 4, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Haihe Biopharma Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•main inclusion:
•Evidence of a personally signed informed consent document;
•Male and/or female subjects above the ages of 18 years;
•Locally advanced or metastatic solid tumor patients who have failed or relapsed on current standard of care for Phase 1a;
•Subject may provide Tumor tissue section(at least 8 pieces) if they agree;
•ECOG performance score 0-1;
•Life expectancy ≥ 12 weeks;
•At least 1 measurable target lesion on the baseline scan as per RECIST 1.1

Exclusion Criteria

•main criteria:
•prior received anti-tumor treatment, including anticancer drugs for the treatment within 28 days of first dose of study treatment;
•Prior or concomitant other malignant tumor;