A Phase 2 interventional study of CYH33 in Ovarian Cancer and Recurrent Cancer, sponsored by Haihe Biopharma Co., Ltd.. Active, not recruiting at 36 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by Haihe Biopharma Co., Ltd. · Phase 2, Interventional, and Treatment
The purpose of this study is to determine the treatment efficacy of CYH33 monotherapy in patients with recurrent or persistent ovarian, fallopian tube or primary peritoneal clear cell carcinoma harboring PIK3CA hotspot mutation, who received prior systemic anti-tumor treatment.
The purpose of this study is to determine whether treatment with single agent CYH33 significantly improves ORR compared to historical efficacy data in patients with recurrent/persistent ovarian clear cell carcinoma (OCCC) harboring PIK3CA hotspot mutations who received prior systemic anti-tumor treatment.
Main Inclusion Criteria:
Main Exclusion Criteria:
Patients are ineligible for this study if they meet any of the following criteria:
40mg daily
Drug: CYH33
a Selective PI3Kα Inhibitor
Tumor ORR in patients with PIK3CA hotspot mutations.
Tumor ORR per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 in patients with PIK3CA hotspot mutations.
Time frame: through study completion, an average of 1 year
PFS
PFS by BIRC using RECIST v1.1
Time frame: through study completion, an average of 1 year
OS
OS in each of the PIK3CA mutation status cohort
Time frame: through study completion, an average of 2 year
genetic and protein biomarker alterations
genetic and protein biomarker alterations that can impact PI3K signaling pathway
Time frame: through study completion, an average of 1 year
Safety and tolerability
type, incidence, duration, severity and seriousness of adverse events (AEs)
Time frame: through study completion, an average of 1 year
DLT (Dose Limiting Toxicity) in Japanese patients
Number and proportion of patients who experienced DLT during the first 28-day of treatment in Japanese patients in safety run-in study.
Time frame: 4 weeks
Peak Plasma Concentration (Cmax)
Pharmacokinetics parameters
Time frame: 4weeks
Area under the plasma concentration versus time curve (AUC)
Pharmacokinetics parameters
Time frame: 4weeks
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Haihe Biopharma Co., Ltd.