To Evaluate the Safety, Tolerance and Pharmacokinetics of BAT8007 for Injection in Patients With Advanced Solid Tumors

NCT05879627 | Terminated Phase 1

• 1 other identifier: BAT-8007-001-CR
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Dose limiting toxicity (DLT)

  number of subjects who experience DLT events during 21 days. Toxicity will be graded according to NCI CTCAE, Version 5.0.

  A minimum of 21 days after first dose of BAT8007

• Adverse Events (AEs)

  Incidence of treatment -related AEs as assessed by NCI CTCAE, Version 5.0.

  AE needs continuous monitoring and evaluation from the first administration to 28 days after the last administration or before receiving new anti-tumor treatment.

Secondary Outcomes (6)

• 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

Study Arms (8)

Cohort 1

EXPERIMENTAL

BAT8007 for Injection does according to protocol (frequency: Q3W)

Drug: BAT8007 for injection

Cohort 2

EXPERIMENTAL

BAT8007 for Injection does according to protocol (frequency: Q3W)

Drug: BAT8007 for injection

Cohort 3

EXPERIMENTAL

BAT8007 for Injection does according to protocol (frequency: Q3W)

Drug: BAT8007 for injection

Cohort 4

EXPERIMENTAL

BAT8007 for Injection does according to protocol (frequency: Q3W)

Drug: BAT8007 for injection

Cohort 5

EXPERIMENTAL

BAT8007 for Injection does according to protocol (frequency: Q3W)

Drug: BAT8007 for injection

Cohort 6

EXPERIMENTAL

BAT8007 for Injection does according to protocol (frequency: Q3W)

Drug: BAT8007 for injection

Cohort 7

EXPERIMENTAL

BAT8007 for Injection does according to protocol (frequency: Q3W)

Drug: BAT8007 for injection

Cohort 8

EXPERIMENTAL

BAT8007 for Injection does according to protocol (frequency: Q3W)

Drug: BAT8007 for injection

Interventions

BAT8007 for injection DRUG

Intravenous infusion: once every three weeks.The infusion time in the first cycle is recommended to be ≥ 90 minutes. If no infusion reaction occurs, the subsequent cycle can be completed within 30\~120 minutes.

Also known as: Recombinant all human anti Nectin-4 monoclonal antibody for injection Exatecan conjugate

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7; Cohort 8

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Suffering from any other disease, physical examination or laboratory examination results, which are not suitable for the use of the study drug according to the judgment of the investigator;
• Subjects who had previously suffered from non infectious pneumonia/pulmonary inflammation requiring glucocorticoid treatment, or currently suffered from interstitial lung disease (ILD), or failed to rule out ILD/pulmonary inflammation through imaging examination during the screening period;
• Untreated or under treatment tuberculosis subjects, including but not limited to tuberculosis; Those who have been treated with standardized anti tuberculosis treatment and confirmed to be cured by researchers can be included;
• Serious infection occurred within 4 weeks or active infection occurred within 2 weeks before the first medication;
• People infected with the following diseases: human immunodeficiency virus (HIV) infection; Active hepatitis B virus infected persons \[hepatitis B surface antigen (HBsAg) is positive, and the detection of hepatitis B virus deoxyribonucleic acid (HBV-DNA) is\>200 IU/ml or 103 copies/ml\]; HCV infected persons \[HCV antibody and viral ribonucleic acid (HCV RNA) detection results are positive\]; Treponema pallidum antibody positive and RPR positive;

Sponsors & Collaborators

• Bio-Thera Solutions: lead
• Zhejiang Tumor Hospital: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Xiangdong Cheng, PI

  Medical Ethics Committee of Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: May 30, 2023
• Study Start: January 17, 2023
• Primary Completion: August 18, 2025
• Study Completion: March 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)