A Study to Evaluate the Efficacy and Safety of CYH33 in Patients With Recurrent/Persistent Ovary Clear Cell Carcinoma

Phase 2

• Conditions: Ovarian Cancer; Recurrent Cancer
• Interventions: Drug: CYH33

• Registration Number: NCT05043922
• Lead Sponsor: Haihe Biopharma Co., Ltd.

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-08-13
• Study First Submitted: 2021-08-30
• Study First Submitted QC: 2021-09-05
• Study First Posted: 2021-09-14
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-09-02
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 86

Inclusion Criteria

1. Female patients ≥ 18 years of age
2. Provide informed consent voluntarily.
3. Patients must have histologically or cytologically confirmed recurrent or persistent ovarian, fallopian tube, or peritoneum clear cell carcinoma.
4. Patients with recurrent/persistent ovary, fallopian tube or primary peritoneal clear cell carcinoma, who have identified PIK3CA status.
5. Patients must have failed standard chemotherapy.
6. ECOG-PS ≤ 1.
7. Patient must have adequate organ and bone marrow function measured within 28 days of screening.

Main

Exclusion Criteria

Patients are ineligible for this study if they meet any of the following criteria:

1. Patient has received any anticancer therapy
2. Patients who had prior treatment with any PI3K, mTOR or AKT inhibitor.
3. Radical radiation therapy within 4 weeks prior to the first dose of the investigational product or received local palliative radiation therapy for bone metastases within 2 weeks.
4. Any toxicities from prior treatment that have not recovered to baseline.
5. Patients who have been treated with any hematopoietic colony-stimulating growth factors ≤ 2 weeks prior to starting study drug.
6. Patients who have symptomatic CNS metastasis.
7. Major surgery or had significant traumatic injury within 28 days prior to the first dose of the investigational product or has not recovered from major side effects.
8. Known HIV infection with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunity infection within the past 12 months; active hepatitis B and hepatitis C.
9. History of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis.
10. Patients with clinically significant cardiovascular disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CYH33	CYH33	40mg daily

Primary Outcome Measures

Name	Time	Method
Tumor ORR in patients with PIK3CA hotspot mutations.	through study completion, an average of 1 year	Tumor ORR per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 in patients with PIK3CA hotspot mutations.

Secondary Outcome Measures

Name	Time	Method
OS	through study completion, an average of 2 year	OS in each of the PIK3CA mutation status cohort
genetic and protein biomarker alterations	through study completion, an average of 1 year	genetic and protein biomarker alterations that can impact PI3K signaling pathway
PFS	through study completion, an average of 1 year	PFS by BIRC using RECIST v1.1

Trial Locations

Locations (36)

Beijing Obstetrics and Gynecology Hospital, Capital Medical University; 🇨🇳 Beijing, China

Chinese PLA General Hospital; 🇨🇳 Beijing, China

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, China

The Southwest Hospital of AMU; 🇨🇳 Chongqing, China

Sun Yat-sen University Cancer Center; 🇨🇳 Guangdong, China

The First Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangdong, China

The First Affiliated Hospital of Hainan Medical College; 🇨🇳 Haikou, China

The Third People's Hospital of Hainan Province; 🇨🇳 Hainan, China

The First Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, China

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