Assessment of Safety and Preliminary Clinical Efficacy with BAT6005 in Advanced Malignant Solid T… (NCT05116709) | Clinical Trial Compass
CompletedPhase 1
Assessment of Safety and Preliminary Clinical Efficacy with BAT6005 in Advanced Malignant Solid Tumors
China28 participantsStarted 2021-11-12
Plain-language summary
This research design for center, increasing openness, dose and dose extension phase I clinical trials, research the main evaluation BAT6005 injection single drug in patients with advanced malignant solid tumors in the safety, tolerability and PK characteristics, to explore the maximum tolerated dose and preliminary antitumor efficacy, provide the basis for subsequent clinical trials recommended dose.
Part I: single drug dose escalation study. Part TWO: dose extension study.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age: ≥18 years old, gender: male or female;
✓. The expected survival was assessed as at least 3 months;
✓. ECOG (Eastern Oncology Collaboration group) physical status score requirement: 0 or 1;
✓. Patients with locally advanced or metastatic malignant solid tumors confirmed by histology or cytology without standard therapy, failure of standard therapy, or inapplicable standard therapy;
✓. According to RECIST 1.1, there must be evaluable tumor focus in dose increase stage, and at least one measurable tumor focus in dose expansion stage;
✓. Fertile women must have a negative serum pregnancy test within 7 days prior to the first dose and be willing to use an effective method of birth control/contraception to prevent pregnancy during the study period up to 6 months after the last dose.Male patients must agree to use an effective contraceptive method for the duration of the study until 6 months after the study's last dosing;Postmenopausal women must be amenorrhea for at least 12 months before they are considered infertile;
Exclusion criteria
✕. Prior treatment with anti-TiGit monoclonal antibody or anti-TiGit active double antibody;
✕. Had received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks prior to the first use of the study drug
✕. Received other unmarketed investigational drugs or treatments within 4 weeks prior to the first use of the investigational drug;
. Received live/attenuated vaccine and mRNA vaccine within 4 weeks prior to screening or plan to receive live/attenuated vaccine and mRNA vaccine during the study period;
✕. Pregnant or lactating women;
✕. Patients whose AE caused by previous anti-tumor therapy did not recover to CTCAE 5.0≤ 1;
✕. Patients with cerebral parenchymal metastasis or meningeal metastasis with clinical symptoms, judged by the investigator to be unsuitable for inclusion;
✕. Patients who underwent major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first use of the study drug, or who required elective surgery during the study period;