Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BAT8008 for Injection
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBio-Thera Solutions
About this trial
Objectives:To evaluate the safety and tolerability of BAT8008 for injection in patients with advanced solid tumors, explore the maximum tolerated dose (MTD), and provide the recommended dose for subsequent clinical trials.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years old, both sexes;
Voluntarily sign the informed consent;
Patients with advanced or metastatic epithelial-derived solid tumors that have been histopathologically or cytologically confirmed, have failed or not been treated with standard therapy, have been intolerant to or have refused standard therapy.
According to RECIST1.1, there is at least one measurable tumor lesion;
Disqualifiers
Within 4 weeks before the first administration of the study drug, he has received experimental drug treatment or participated in clinical research of medical devices;
Have received other anti-tumor treatment within 4 weeks before the first administration of the study drug, such as chemotherapy, radiotherapy (palliative radiotherapy should be completed within 2 weeks before the first administration), targeted therapy/immunotherapy (at least 4 weeks or at least 5 half-life, whichever is shorter), hormone therapy (except alternative therapy);
Within 2 weeks before the first administration of the study drug, he has received the treatment of traditional Chinese medicine, Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) with anti-tumor effect;
Before the first administration of the study drug, AE (CTCAE5.0) caused by previous anti-tumor treatment was still greater than grade 1, except for the following conditions: a. alopecia; B pigmentation; c. The distal toxicity caused by chemotherapy and radiotherapy can not be further recovered after judgment;
Trial design
Design model
Sequential
Treatments tested in this trial
BAT8008 for Injection
DrugIntravenous infusion, once every 2 weeks (Q2W). It is recommended that the infusion time of the first cycle should be ≥ 3 hours. If no infusion reaction occurs, the subsequent circulation can be completed within 1-2 hours.
Treatment groups
182 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Group A: A/0.8mg/kgExperimental treatment 1 intervention
Group B: B/1.2mg/kgExperimental treatment 1 intervention
Group C: C/2.4mg/kgExperimental treatment 1 intervention
Group D: D/3.6mg/kgExperimental treatment 1 intervention
Group E: E/4.8mg/kgExperimental treatment 1 intervention
Group F: F/6.0mg/kgExperimental treatment 1 intervention
Group G: G/7.2mg/kgExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose limiting toxicity (DLT)
DLT was defined as grade 3 or higher toxicity associated with the investigational product that occurred within 21 days of the subject's initial administration
Time frame
At the end of Cycle 1( first cycle is 21 days, subsequent cycles are 14 days)2
Maximum tolerated dose (MTD)
MTD was defined as exploration in a dose group observed ≤1/6 of subjects during the DLT evaluation period to the highest dose level of DLT.
Time frame
At the end of Cycle 1( first cycle is 21 days, subsequent cycles are 14 days)Secondary outcomes
1
AUC(0-inf)after cycle 6 administration
The area under the concentration-time curve extrapolated from time 0 to infinity
Time frame
91 days after first dose of BAT8008Other outcomes
1
Presence of ADA/nentralizing antibodies（NAbs）
presence of anti-drug antibody/ nentralizing antibodies
Time frame
91 days after first dose of BAT8008Sponsors and contacts
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Source ClinicalTrials.gov