NCT05879627
Terminated
Phase 1
A Multicenter, Open Phase I Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetics of BAT8007 for Injection in Patients With Advanced Solid Tumors
Bio-Thera Solutions1 site in 1 country93 target enrollmentJanuary 17, 2023
Overview
- Phase
- Phase 1
- Intervention
- BAT8007 for injection
- Conditions
- Advanced Solid Tumors
- Sponsor
- Bio-Thera Solutions
- Enrollment
- 93
- Locations
- 1
- Primary Endpoint
- Dose limiting toxicity (DLT)
- Status
- Terminated
- Last Updated
- 19 days ago
Overview
Brief Summary
A multicenter, open phase I clinical study to evaluate the safety, tolerance and pharmacokinetics of BAT8007 for injection in patients with advanced solid tumors.
Detailed Description
This is a multicenter, open, dose increasing and dose expanding Phase I clinical study. About 169\~292 patients will be enrolled from research centers in China, the United States, Australia, etc. In the dose increasing stage, accelerated titration and "3+3" dose increasing design were used to explore the safety, tolerance and PK characteristics of BAT8007 for injection in patients with advanced solid tumors. During the dose increasing test, select the appropriate dose according to the previous study data for the extended study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 to 75 years old (including the boundary value), regardless of gender;
- •Sign the informed consent form voluntarily;
- •Dose-climbing studies: cytologically or histologically confirmed patients with advanced solid tumors who failed standard therapy, had no standard therapy, were intolerant to standard therapy, or refused to receive standard therapy; Dose-expansion studies: Patients with cytologically or histologically confirmed locally advanced/metastatic urothelial carcinoma or other advanced or metastatic solid tumors with cytologically or histologically confirmed failure of standard therapy or intolerance to standard therapy (at least first-line systemic antitumor therapy).
- •Patients in the dose increasing study must have an evaluable tumor focus, and patients in the dose expanding study must have at least one measurable tumor focus (according to RECIST 1.1 standard);
- •The physical status score of the East American Cooperative Oncology Group (ECOG) is required to be 0 or 1;
- •The investigator assessed that the expected survival period was ≥ 12 weeks;
- •Prepare sufficient organ and bone marrow reserve function, and the definition is as follows: blood routine test (no blood component, cell growth factor support treatment and no drug to correct the number of blood cells within 14 days before the first administration), absolute neutrophil count (ANC) ≥ 1.5 × 109/L platelet count ≥ 90 × 109/L hemoglobin ≥ 90g/L coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (those not receiving anticoagulation therapy) can be included in patients receiving oral anticoagulation therapy with INR of 2-3; Subjects currently receiving intravenous or subcutaneous anticoagulation therapy must be excluded. Liver function: total bilirubin (TBIL) generally ≤ 1.5 × ULN； Hepatocellular carcinoma, liver metastasis ≤ 2 × ULN alanine aminotransferase (ALT), aspartate aminotransferase (AST) generally ≤ 2.5 × ULN； Hepatocellular carcinoma, liver metastasis ≤ 5 × ULN Renal function: serum creatinine ≤ 1.5 × ULN or serum creatinine clearance\>60ml/min (Cockcroft Gault formula is adopted, see appendix)
- •Female patients with fertility must have negative serum pregnancy test within 7 days before the first administration and be willing to take effective birth control/contraception methods to prevent pregnancy during the study period until 6 months after the last administration. Male patients must agree to take effective contraceptive methods during the study period until 6 months after the last administration of the drug; Postmenopausal women must be amenorrhoea for at least 12 months before they are considered infertile;
- •We must agree to abide by the epidemic prevention regulations of the host country and region against COVID-19 novel coronavirus, and minimize the exposure to COVID-19 from the screening period to the end of the study (28 days of safety follow-up);
- •Able to understand the test requirements, willing and able to follow the test and follow-up procedures.
Exclusion Criteria
- •Within 4 weeks before the first administration of the study drug, he received experimental drug treatment;
- •Subjects who have received previous treatment with Nectin-4 or related target research drugs (not limited to antibody, ADC, etc.);
- •Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first use of the study drug, except for the following: ① Nitrosourea or mitomycin C within 6 weeks before the first use of the study drug; ② Oral fluorouracil and small molecule targeted drugs were taken 2 weeks before the first use of the study drug or within 5 half lives of the drug (whichever is longer); ③ Within 2 weeks before the first use of the investigational drug, the systematic treatment of traditional Chinese medicine/Chinese patent medicine with clear anti-tumor effect and drugs with immunomodulatory effect (including but not limited to thymosin, interferon, interleukin, etc.); ④ Palliative radiotherapy was performed within 2 weeks before the first use of the study drug;
- •After receiving any topoisomerase I inhibitor (such as irinotecan) in the past, there has been a drug related or unknown AE ≥ 3 levels (using CTCAE version 5.0 for grading);
- •Before the first administration of the study drug, AE (CTCAE version 5.0) caused by previous anti-tumor treatment was still greater than grade 1, except for the following circumstances: a. alopecia; B pigmentation; c. The distal neurotoxicity caused by chemotherapy and radiotherapy can not be further recovered after judgment; d. Stable hypothyroidism after hormone replacement therapy;
- •Patients who have undergone major surgery or have not recovered from surgery within 4 weeks before the first administration of the study drug, or have experienced significant trauma, or need to undergo elective surgery during the trial. Note: Those who have undergone minor surgery ≥ 28 days before screening must have fully recovered from the surgery before the first administration, except for the indwelling operation at the intravenous infusion port;
- •Have a history of allograft cell or solid organ transplantation;
- •Primary central nervous system tumor or symptomatic central nervous system metastasis (meningeal metastasis with or without symptoms must be excluded). Patients with asymptomatic or symptomatic central nervous system metastasis who have reached clinical control but are judged by the researcher to be stable can be included, but the following conditions must be met simultaneously: a The clinical symptoms were stable ≥ 4 weeks before the first administration; b. No evidence of progression of central nervous system disease was found in brain MRI enhancement within 4 weeks before the first administration; c. The antiepileptic drugs have been stopped at least 2 weeks before the first medication;
- •In the dose expansion study, there were other active malignant tumors within 3 years before the first administration. Except for locally cured tumors (such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer or breast cancer in situ);
- •The following cardiovascular diseases occurred within 6 months before the first drug use: symptomatic heart failure with NYHA grade of 2 or above, left ventricular ejection fraction (LVEF)\<50%, unstable arrhythmia or unstable angina pectoris, myocardial infarction requiring treatment, pulmonary embolism Uncontrolled hypertension (this protocol is defined as systolic blood pressure \> 160mmHg and/or diastolic blood pressure \> 100mmHg after treatment, although the optimal antihypertensive treatment is used, and it is evaluated by the researcher as clinically significant). Note: 3 times of 12 lead ECG suggested that QTc interval extension\>450 ms (male) or\>470 ms (female) should be excluded; The patients with atrial fibrillation or paroxysmal supraventricular tachycardia that must be treated can be considered to be included after the investigator has assessed that the condition is stable;
Arms & Interventions
Cohort 7
BAT8007 for Injection does according to protocol (frequency: Q3W)
Intervention: BAT8007 for injection
Cohort 8
BAT8007 for Injection does according to protocol (frequency: Q3W)
Intervention: BAT8007 for injection
Cohort 1
BAT8007 for Injection does according to protocol (frequency: Q3W)
Intervention: BAT8007 for injection
Cohort 2
BAT8007 for Injection does according to protocol (frequency: Q3W)
Intervention: BAT8007 for injection
Cohort 3
BAT8007 for Injection does according to protocol (frequency: Q3W)
Intervention: BAT8007 for injection
Cohort 4
BAT8007 for Injection does according to protocol (frequency: Q3W)
Intervention: BAT8007 for injection
Cohort 5
BAT8007 for Injection does according to protocol (frequency: Q3W)
Intervention: BAT8007 for injection
Cohort 6
BAT8007 for Injection does according to protocol (frequency: Q3W)
Intervention: BAT8007 for injection
Outcomes
Primary Outcomes
Dose limiting toxicity (DLT)
Time Frame: A minimum of 21 days after first dose of BAT8007
number of subjects who experience DLT events during 21 days. Toxicity will be graded according to NCI CTCAE, Version 5.0.
Adverse Events (AEs)
Time Frame: AE needs continuous monitoring and evaluation from the first administration to 28 days after the last administration or before receiving new anti-tumor treatment.
Incidence of treatment -related AEs as assessed by NCI CTCAE, Version 5.0.
Secondary Outcomes
- Anti-drug antibodies (ADA)(up to Cycle 3, each cycle is 14 days)
- neutralizing antibodies (NAb)(up to Cycle 3, each cycle is 14 days)
- Cmax(up to Cycle 3, each cycle is 14 days)
- Tmax (Time to reach maximum serum concentration)(up to Cycle 3, each cycle is 14 days)
- T1/2 (terminal half-life)(up to Cycle 3, each cycle is 14 days)
- Systemic Clearance (CL)(up to Cycle 3, each cycle is 14 days)
Study Sites (1)
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