Clinical Trials /

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

NCT04236362

Description:

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.

Related Conditions:
  • Fallopian Tube Carcinoma
  • Malignant Ovarian Epithelial Tumor
  • Primary Peritoneal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of TQB2450 Combined With Anlotinib in Subjects With Ovarian Cancer
  • Official Title: A Phase Ib, Single Arm, Open Study of TQB2450 Combined With Anlotinib in Subjects With Relapsed / Refractory Ovarian Cancer

Clinical Trial IDs

  • ORG STUDY ID: TQB2450-Ib-10
  • NCT ID: NCT04236362

Conditions

  • Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Interventions

DrugSynonymsArms
TQB2450TQB2450+Anlotinib
AnlotinibTQB2450+Anlotinib

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
TQB2450+AnlotinibExperimentalTQB2450 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)
  • TQB2450
  • Anlotinib

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. Diagnosed with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal
             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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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

Secondary Outcome Measures

Measure:Progression free survival (PFS)
Time Frame:up to 96 weeks
Safety Issue:
Description:PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Measure:Duration of Response (DOR)
Time Frame:up to 96 weeks
Safety Issue:
Description:Time from tumor first assessment to CR or PR to first assessment to PD (Progressive Disease) or death from any cause
Measure:Disease control rate(DCR)
Time Frame:up to 96 weeks
Safety Issue:
Description:Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).
Measure:Overall Survival (OS)
Time Frame:up to 120 weeks
Safety Issue:
Description: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.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Last Updated

January 21, 2020