A Study to Evaluate the Efficacy and Safety of Anti-PD-1 Antibody AK105 in Patients With Selected Advanced Solid Tumors

  • STATUS
    Recruiting
  • days left to enroll
    30
  • participants needed
    150
  • sponsor
    Akeso
Updated on 23 January 2021
measurable disease
solid tumor
advanced malignant solid tumor

Summary

This is a multi-center, multi-cohort, open-label, phase Ib/II study to evaluate the efficacy, safety, PK characteristics, immunogenicity and potential biomarkers of AK105 monotherapy in the patients with selected advanced solid tumors.

Details
Condition Pulmonary Disease, Lung Neoplasm, HEPATOCELLULAR CARCINOMA, Bronchial Neoplasm, Solid Tumors, Solid Tumor, Solid Neoplasm, Solid Tumour, Lung Cancer, Lung Disease, liver cell carcinoma, carcinoma lung, lung carcinoma
Treatment AK105
Clinical Study IdentifierNCT04172506
SponsorAkeso
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Written and signed informed consent
Aged over 18 and less than 75 years at the time of signing the informed consent form, both female and male
ECOG PS is 0-1
The expected survival time is 3months
Histologically or cytologically confirmed selected advanced solid tumor
Subject must have at least one measurable lesion according to RECIST Version1.1
Available archived tumor tissue sample to allow for correlative biomarker studies. In the setting where archival material is unavailable or unsuitable for use, the subject must consent and undergo fresh tumor biopsy
Adequate organ function
Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception from Day 1 and for 120 days after the last dose of investigational product
Nonsterilized males who are sexually active with a female partner of childbearing potential must use highly effective method of contraception from Day 1 and for 120 days after the last dose of investigational product
Be willing and able to comply with scheduled visits, treatment regimens, laboratory tests and other requirements for the study

Exclusion Criteria

Had received experimental drug or used experimental device in the past within 4 weeks prior to the first dose of study drug
Receipt of last radiotherapy or any anti-tumor treatment [chemotherapy, targeted therapy, immunotherapy, Chinese patent drugs with antitumor indications, or immunomodulators or tumor embolization] within 4 weeks prior to the first dose of study drug
Had received any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, etc.), or any other antibody or drug therapy for T cell co-stimulatory or checkpoint pathways (such as ICOS, CD40, CD137, GITR, OX40 antibody or drug), immunocytotherapy, therapeutic antibody, etc.)
Patients with active, known or suspected autoimmune disease, or a medical history of autoimmune disease, with the exceptions of the following: vitiligo, alopecia, Grave disease, psoriasis or eczema not requiring systemic treatment within the last 2 years, hypothyroidism (caused by autoimmune thyroiditis) only requiring steady doses of hormone replacement therapy and type I diabetes only requiring steady doses of insulin replacement therapy, or completely relieved childhood asthma that requires no intervention in adulthood, or primary diseases that will not relapse unless triggered by external factors
Active or previously recorded inflammatory bowel diseases (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea)
Patients with a condition requiring systemic treatment with either corticosteroid (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration
Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
Large surgical procedures (defined by researchers as open biopsy, severe trauma, etc.) were performed within 28 days prior to the first dose of study drug
Known history of interstitial lung disease
Patients with untreated chronic hepatitis B or HBV DNA exceeding 1000IU/mL or active hepatitis C. Patients with HCV antibody positive are eligible to participate in the study if the results of HCV RNA test show negative
Patients with active tuberculosis (TB)
History of known primary immunodeficiency virus infection or positive HIV testing
Severe infections within 4 weeks prior to the first dose of study drug, including but not limited to complications, sepsis or severe pulmonary infections requiring hospitalization
Patients with meningeal metastasis, spinal cord compression, pia mater disease or active brain metastasis. Patients who meet one of the following requirements may be enrolled: a). No central nervous system metastasis symptoms and signs, such as neurological dysfunction, epilepsy or other central nervous system metastasis before admission. No edema around the lesion found by imaging examination, and no brain metastasis more than 1.5 cm in length. b). Patients with central nervous system metastasis had received treatment and achieved asymptomatic status (e.g. without neurological dysfunction, epilepsy or other typical central nervous system metastasis symptoms and signs)
Patients with pleural effusion, pericardial effusion or ascites that could not be controlled stably by repeated drainage or other methods as judged by the investigator
Receipt of live, attenuated vaccination within 30 days prior to the first dose of study treatment, or plan to receive live, attenuated vaccine during the study
Known history of sever hypersensitivity reaction to other monoclonal antibodies
Known history of allergy or hypersensitivity to AK105 or any of its components
Any conditions that, in the investigator's opinion, may put subjects treated with the study drug at risks, or interfere with the evaluation of study drug or subject safety, or the interpretation of results
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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