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

NCT04236362 | Unknown Phase 1

• 1 other identifier: TQB2450-Ib-10
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR)

  up to 96 weeks

Secondary Outcomes (4)

• Progression free survival (PFS)

  up to 96 weeks

• Duration of Response (DOR)

  up to 96 weeks

• Disease control rate（DCR）

  up to 96 weeks

• Overall Survival (OS)

  up to 120 weeks

Study Arms (1)

TQB2450+Anlotinib

EXPERIMENTAL

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; Drug: Anlotinib

Interventions

TQB2450 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.

TQB2450+Anlotinib

Anlotinib DRUG

A multi-target receptor tyrosine kinase inhibitor

TQB2450+Anlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understood and signed an informed consent form;
• years and older, male or female, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, life expectancy ≥ 3 months;
• Histologically confirmed, unresectable recurrent/metastatic advanced gynecologic cancer, including ovarian, endometrial, and cervical cancer;
• 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;
• At least one measurable lesion according to the RECIST 1.1;
• The main organs function are normally;
• 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.

You may not qualify if:

• Has other non-epithelial ovarian tumors or borderline ovarian epithelial tumors;
• 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;
• Has previously received immune drugs such as PD-1 / PD-L1, CTLA-4 or other tyrosine kinase inhibitors such as anlotinib hydrochloride;
• Has received bevacizumab within 28 days before the first dose;
• 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;
• 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;
• 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;
• Active autoimmune diseases that require systemic treatment have occurred within 2 years before the first dose;
• 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;
• Has uncontrollable symptoms of brain metastases, spinal cord compression, cancerous meningitis;
• Has any bleeding or bleeding event ≥ CTC AE Grade 3 or unhealed wounds, ulcers or fractures within 4 weeks before the first dose;
• Has clinically significant thyroid dysfunction before the first dose;
• Has multiple factors affecting oral medication;
• Has any severe acute complications before the first dose;
• Has participated in other anti-tumor intervention clinical trials within 4 weeks before the first medication;

Sponsors & Collaborators

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

Study Sites (5)

The General Hospital of the People's Liberation Army

Beijing, Beijing Municipality, 100039, China

RECRUITING

Cancer Hospital of Chongqing University

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

First Hospital of Qinhuangdao

Qinhuangdao, Hebei, 066000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 35858589 DERIVED

MeSH Terms

Interventions

anlotinib

Central Study Contacts

Xin Huang

CONTACT

020-87343014; huangxin@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2020
• First Posted: January 22, 2020
• Study Start: February 27, 2020
• Primary Completion: December 31, 2021
• Study Completion: May 30, 2022
• Last Updated: January 12, 2021

Record last verified: 2021-01

Locations

CN (5)