Study of TQB2450 Combined With Anlotinib in Patients With Advanced Solid Tumors

  • STATUS
    Recruiting
  • days left to enroll
    86
  • participants needed
    22
  • sponsor
    Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Updated on 23 January 2021

Summary

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. As a novel multitarget tyrosine kinase inhibitor for tumor angiogenesis and proliferative signalinganlotinib is approved for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have undergone progression or recurrence after 2 lines of systemic chemotherapy. The Phase III study showed that the Overall Survival (OS), Progression-Free Survival (PFS) and Overall Response Rate (ORR) were significantly better than placebo group.

Details
Condition Advanced Solid Tumors
Treatment Anlotinib, TQB2450
Clinical Study IdentifierNCT03897283
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically or cytologically confirmed advanced or metastatic solid tumor that is failure or absence of standard therapy with measurable lesion
18-70 years oldEastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy 3 months
The main organs function are normally, the following criteria are met
routine blood testshemoglobin (Hb) 90g/L (no blood transfusion and blood
products within 14 days); absolute neutrophil count (ANC) 1.5109/L; platelets
(PLT) 100109/L
Blood biochemical examination: alanine transaminase (ALT) and aspartate
aminotransferase (AST) 2.5ULN (when the liver is invadedAST 5ULN); total
bilirubin (TBIL) 1.5ULN (Gilbert syndrome patientsTBIL 3ULN)serum creatinine
(Cr) 1.5ULNor calculated creatinine clearance (CrCl) 60 ml/min
Coagulation function: activated partial thromboplastin time (APTT)
international normalized ratio (INR) prothrombin time (PT) 1.5ULN
left ventricular ejection fraction (LVEF) measured by the Cardiac
echocardiography 50%
\. 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
\. Understood and signed an informed consent form

Exclusion Criteria

Prior therapy with anlotinib, anti-programmed cell death (PD)-1, anti-PD-L1 or other immunotherapy against PD-1/PD-L1
Severe hypersensitivity occurs after administration of other monoclonal antibodies
Has diagnosed and/or treated additional malignancy within 5 years prior to randomization. Exceptions include cured basal cell carcinoma of skin and carcinoma in situ of cervix
Has any active autoimmune disease or history of autoimmune disease, such as autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis, asthma patients who need bronchiectasis for medical intervention; Subjects with the vitiligo without systemic treatment, psoriasis, alopecia, well-controlled type I diabetes mellitus, hypothyroidism stable on hormone replacement will not be excluded from this study
Immunosuppressive therapy with immunosuppressive agents or systemic or absorbable local hormones (dosage > 10 mg/day prednisone or other therapeutic hormones) is required for the purpose of immunosuppression, and is still in use for 2 weeks after the first administration
Has multiple factors affecting oral medication, such as inability to swallow, post-gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc
Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
Has spinal cord compression which was not cured or relieved through surgery and/or radiotherapy, or diagnosed spinal cord compression after treatment showed no clinical evidence of disease stabilization prior to randomization 1 week
Has any bleeding or bleeding events grade 3 or with unhealed wounds, ulcerative , or fractures within 4 weeks prior to the first administration
Has known central nervous system (CNS) metastases and/or carcinomatous meningitis. subjects with treated brain metastases may participate provided the following criteria are met Has no evidence of new or enlarging brain metastases at least two weeks after treatment of brain metastases Has stopped using corticosteroid before randomization, or used less than 10 mg prednisone or steady dose at least two weeksIf the patient is found to have active or new untreated or asymptomatic CNS metastases during the screening period, radiotherapy and/or operation for CNS metastatic lesion must be performed
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
Has adverse events caused by previous therapy except alopecia that did not recover to grade 1
Has major surgical procedurebiopsy or obvious traumatic injury within 28 days before randomization
Has arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident including transient ischemic attack, deep vein thrombosis and pulmonary embolism
Has drug abuse history that unable to abstain from or mental disorders
Patients with any serious and/or uncontrollable disease, including
Has poor blood pressure control, systolic blood pressure 150 mmHg, diastolic blood pressure 90 mmHg
Thrombotic events, ischemic attacks, myocardial infarction, grade 2 congestive heart failure or arrhythmias requiring treatment including QTc 480ms occurred within 6 months of first administration
Severe active or uncontrolled infections grade 2
Has known clinical history of liver diseases, including viral hepatitis, known carriers of hepatitis B virus (HBV) must exclude active HBV infection, that is, HBV DNA positive > 1 104 copies/mL or > 2000 IU/mL, known hepatitis C virus infection (HCV) and HCV RNA positive > 1 103 copies/mL, or other decompensated hepatitis and chronic hepatitis, which require antiviral treatment
HIV positive
Poor control of diabetes mellitus, fasting blood-glucose grade 2
Urinary routine indicated that urinary protein ++ and confirmed 24-hour urinary protein quantification > 1.0 g
Has vaccinated with vaccines or attenuated vaccines within 4 weeks prior to first administration
Has participated in other anticancer drug clinical trials within 4 weeks
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
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