FP-208 recruits patients with clear cell kidney cancer, breast cancer, ovarian cancer, and endometrial cancer

Image: Pexels | Written by: Medical Companion Travel Content Team

Original articles, please do not reprint without permission

Beijing Fulong Kangtai Biotechnology Co., Ltd. has targeted the development of mTORC1/mTORC2 dual inhibitor FP-208 based on new targets and new mechanisms, the chemical structure of which is the first in the world, is a new anti-tumor drug with independent intellectual property rights, and its mTOR inhibitory activity is about 10 times stronger than PI3Ka, but the inhibition of PI3Kb, g and d subtypes is very weak.

The unique chemical structure of FP-208 makes it both water-soluble (5 mg/ml) and high oral utilization, which can be used both for oral and intravenous administration. In foreign countries, mTORC1/mTORC2 inhibitors have entered a number of Phase II clinical trials. Domestic patients who want to use mTORC1/mTORC2 inhibitors for free can participate in this clinical trial.

Renal clear cell carcinoma is a common type of kidney cancer, accounting for 70% to 80% of kidney cancer, and cancer cells are often arranged in flakes, cords or tubes. It is more common in people around the age of 60, with more men than women. Patients may have no obvious clinical symptoms in the early stages or only fever, fatigue and other symptoms. As the tumor increases in size, discomfort such as hematuria, pain in the renal area, and the mass can be reached. Renal clear cell carcinoma can be definitively diagnosed with clinical symptoms and adjunctive tests such as urography, renal ultrasound, renal CT, or magnetic resonance imaging.

Breast cancer is a malignant tumor that occurs in the glandular epithelial tissue of the breast and develops from the breast tissue. 99% of breast cancers occur in women, compared to only 1% of men. Breast cancer has become a major public health problem in the current society, its cause is not yet fully understood, the study found that there is a certain regularity in the incidence of breast cancer, and women with high risk factors for breast cancer are prone to breast cancer. In February 2021, WHO cancer experts said that breast cancer had become the most common cancer in the world among the cancers diagnosed in 2020.

Ovarian cancer is a malignant tumor of the ovarian tumor, which refers to the malignant tumor that grows on the ovary, of which 90% to 95% is the primary cancer of the ovaries, and the other 5% to 10% is the primary cancer metastasis to the ovaries in other parts. Due to the lack of symptoms in the early stage of ovarian cancer, even if there are symptoms are not specific, and the role of screening is limited, early diagnosis is more difficult, 60% to 70% of the time of treatment is advanced, and the effect of advanced cases is not good. Therefore, although the incidence of ovarian cancer is lower than that of cervical cancer and endometrial cancer, which ranks third in gynecological malignancy, the mortality rate exceeds the sum of cervical cancer and endometrial cancer, ranking first in gynecological cancer and is the biggest disease that seriously threatens women's health.

Endometrial cancer is an epithelial tumor that occurs in the endometrium. During the fertility period, the endometrium is regularly thickened every month, then it becomes thinner when menstruation comes, and the next menstrual cycle will be regularly thickened. So it is a kind of tissue that is changing, and if a malignant tumor occurs in this tissue, it is called endometrial cancer. Endometrial cancer is not a particularly common tumor in the female reproductive system. Endometrial cancer has also tended to increase in incidence in recent years, accounting for about 7% of female tumors and about 30% of female reproductive system tumors.

01

Experimental drug

FP-208

02

Indications

Clear cell kidney cancer, breast cancer, ovarian cancer and endometrial cancer

03

Purpose of the test

The main objective is to assess the safety and pharmacokinetic profile of FP-208 in patients with advanced solid tumors, and the secondary purpose is to initially assess antitumor activity and explore the relationship between the biomarker pS6 drug and efficacy.

04

Main selection criteria

1. Between the ages of 18 and 65 (including the boundary between the two ends), gender is not limited

2. Patients with advanced solid tumors who have been confirmed by histology or cytology, failed standard therapy or have no standard treatment plan, including but not limited to kidney cancer, breast cancer, neuroendocrine tumor, sarcoma, liver cancer and ovarian cancer

3. ECOG stamina score 0 or 1

4. Expected survival time of more than 3 months

5. Ability to use oral tablets of the drug

6. According to the RECIST 1.1 standard, with tumor lesions that can be evaluated or measured

05

Primary exclusion criteria

1. Have received any anti-tumor therapy or any surgical procedure within 28 days before the first administration

2. Participated in other therapeutic clinical trials within 30 days prior to the first administration

3. Those who have received strong or moderate inhibitors or inducers of the cytochrome metabolic enzyme CYP3A4 21 days before the first administration or 5 elimination half-life

4. Patients who have received strong or moderate inhibitors or inducers of the cytochrome metabolic enzyme CYP3A4 21 days before the first administration or 5 elimination half-life

5. Patients who are known to be allergic to FP-208 or similar drugs (PI3K inhibitors or mTOR inhibitors) or to other components of FP-208

06

【Location of the main research center (the specific start-up situation is subject to the later consultation)】

Beijing

Participating in clinical trials can receive free treatment for new therapies, and patients interested in participating in this clinical trial can consult a medical companion. Note: Whether you can finally join the group needs to be determined by the doctor.