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

Haihe Biopharma

Status and phase: Active, not recruiting; Phase 2

Conditions: Recurrent Cancer; Ovarian Cancer

Treatments: Drug: CYH33

Study type: Interventional

Funder types: Industry

Identifiers

NCT05043922

CYH33-G201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

93 participants in 1 patient group

CYH33

Experimental group

Description:

40mg daily

Treatment:

Drug: CYH33