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

A Phase Ib, Single Arm, Open-label Study of TQB2450 Combined With Anlotinib in Subjects With Relapsed / Refractory Gynecological Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Gynecological Cancer
• Intervention / Treatment: Drug: TQB2450; Drug: Anlotinib

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100039
      • Recruiting
      • The General Hospital of the People's Liberation Army
      • Contact: Shunchang Jiao; Phone Number: 13801380677; Email: jiaosc@vip.sina.com
      • Principal Investigator: Shunchang Jiao
  • Chongqing
    • Chongqing, Chongqing, China, 400030
      • Recruiting
      • Cancer Hospital of Chongqing University
      • Principal Investigator: Qi Zhou
      • Contact: Qi Zhou; Phone Number: 13708384529; Email: qizhou9128@163.com
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • Recruiting
      • The First Hospital of Lanzhou University
      • Contact: Liu Chang; Email: 44025660@qq.com
      • Principal Investigator: Liu Chang
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Sun yat-sen University Cancer Center
      • Contact: Xin Huang; Phone Number: 020-87343014; Email: huangxin@sysucc.org.cn
      • Principal Investigator: Xin Huang
  • Hebei
    • Qinhuangdao, Hebei, China, 066000
      • Recruiting
      • First Hospital of Qinhuangdao
      • Contact: Jin Haihong; Email: jhh660625@sina.com
      • Principal Investigator: Jin Haihong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: 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.; Drug: Anlotinib; A multi-target receptor tyrosine kinase inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR)	up to 96 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival (PFS)	PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.	up to 96 weeks
Duration of Response (DOR)	Time from tumor first assessment to CR or PR to first assessment to PD (Progressive Disease) or death from any cause	up to 96 weeks
Disease control rate（DCR）	Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).	up to 96 weeks
Overall Survival (OS)	OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.	up to 120 weeks

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): May 30, 2022

Study Registration Dates

• First Submitted: January 18, 2020
• First Submitted That Met QC Criteria: January 21, 2020
• First Posted (Actual): January 22, 2020

Study Record Updates

• Last Update Posted (Actual): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 10, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: TQB2450-Ib-10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No