A Study of TQB2450 Combined With Anlotinib in Subjects With Gynecological Cancer

NCT ID: NCT04236362

Last Updated: 2021-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-27
• Study Completion Date: 2022-05-30

Brief Summary

This is a single-arm, open-label, phase Ib clinical trial to evaluate the efficacy and safety of TQB2450 combined with anlotinib in subjects with gynecological cancer, including 34 ovarian cancer，34 endometrial cancer，22 cervical cancer.

Conditions

Gynecological Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQB2450+Anlotinib

TQB2450 1200 mg IV on Day 1 of each 21-day cycle plus Anlotinib capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)

Group Type: EXPERIMENTAL

TQB2450

Intervention Type: DRUG

TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.

Anlotinib

Intervention Type: DRUG

A multi-target receptor tyrosine kinase inhibitor

Interventions

TQB2450

TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.

Intervention Type: DRUG

Anlotinib

A multi-target receptor tyrosine kinase inhibitor

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Understood and signed an informed consent form;

2. 18 years and older, male or female, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, life expectancy ≥ 3 months;

3. Histologically confirmed, unresectable recurrent/metastatic advanced gynecologic cancer, including ovarian, endometrial, and cervical cancer;

4. Subjects have received at least 1 line platinum-containing chemotherapy (minimum of 4 cycles of platinum-containing treatment) after tumor reduction, and meet any of the following：Platinum-resistant or refractory patients, including patients who have progressed or relapsed during previous platinum-containing chemotherapy regimens or within 6 months after the end of platinum-containing chemotherapy;

5. At least one measurable lesion according to the RECIST 1.1;

6. The main organs function are normally;

7. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.

Exclusion Criteria

1. Has other non-epithelial ovarian tumors or borderline ovarian epithelial tumors;

2. Other malignant tumors that have appeared or are currently present within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors;

3. Has previously received immune drugs such as PD-1 / PD-L1, CTLA-4 or other tyrosine kinase inhibitors such as anlotinib hydrochloride;

4. Has received bevacizumab within 28 days before the first dose;

5. Has received chemotherapy, surgery, radiotherapy, the last treatment from the first dose less than 4 weeks, or oral targeted drugs for less than 5 half-lives, or oral fluorouracil pyridine drugs for less than 14 days, mitomycin C and nitrosourea for less than 6 weeks;

6. Expect to use any active vaccine against infectious diseases (such as influenza vaccine, chickenpox vaccine, etc.) within 28 days before the first dose or during the study period;

7. Patients diagnosed with immunodeficiency or undergoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose> 10mg / day prednisone or other effective hormones) and continue to use it within 2 weeks before the first dose;

8. Active autoimmune diseases that require systemic treatment have occurred within 2 years before the first dose;

9. Subjects known to be allergic to the study drug or any of its excipients or have experienced a severe allergic reaction to other monoclonal antibodies;

10. Has uncontrollable symptoms of brain metastases, spinal cord compression, cancerous meningitis;

11. Has any bleeding or bleeding event ≥ CTC AE Grade 3 or unhealed wounds, ulcers or fractures within 4 weeks before the first dose;

12. Has clinically significant thyroid dysfunction before the first dose;

13. Has multiple factors affecting oral medication;

14. Has any severe acute complications before the first dose;

15. Has participated in other anti-tumor intervention clinical trials within 4 weeks before the first medication;

16. According to the judgement of the researchers, there are other factors that may lead to the termination of the study. For example, other serious diseases including mental disorders need to be treated together, serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subjects, or the collection of data and samples.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The General Hospital of the People's Liberation Army

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Cancer Hospital of Chongqing University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Site Status: RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

First Hospital of Qinhuangdao

Qinhuangdao, Hebei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xin Huang

Role: CONTACT

huangxin@sysucc.org.cn

020-87343014

Facility Contacts

Shunchang Jiao

Role: primary

jiaosc@vip.sina.com

13801380677

Qi Zhou

Role: primary

qizhou9128@163.com

13708384529

Liu Chang

Role: primary

44025660@qq.com

Xin Huang

Role: primary

huangxin@sysucc.org.cn

020-87343014

Jin Haihong

Role: primary

jhh660625@sina.com

References

Lan CY, Zhao J, Yang F, Xiong Y, Li R, Huang Y, Wang J, Liu C, Bi XH, Jin HH, Meng J, Zhao WH, Zhang L, Wang YF, Zheng M, Huang X. Anlotinib combined with TQB2450 in patients with platinum-resistant or -refractory ovarian cancer: A multi-center, single-arm, phase 1b trial. Cell Rep Med. 2022 Jul 19;3(7):100689. doi: 10.1016/j.xcrm.2022.100689.

Reference Type: DERIVED

PMID: 35858589 (View on PubMed)

Other Identifiers

TQB2450-Ib-10

Identifier Type: -

Identifier Source: org_study_id