Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BAT8006 for Injection

Last updated: January 3, 2026
Sponsor: Bio-Thera Solutions
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

BAT8006 for Injection

Clinical Study ID

NCT05378737
BAT-8006-001-CR
  • Ages 18-75
  • All Genders

Study Summary

Objectives: To evaluate the safety and tolerability of BAT8006 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

Inclusion

Inclusion Criteria:

  • The following items were satisfied to be included in the study:
  1. Age 18 to 75 years old (including the boundary value), gender is not limited;

  2. Voluntarily sign informed consent;

  3. For different cohorts, subjects should meet the following requirements: 3-1) Dose escalation studies: Patients must be histologically or cytologicallyconfirmed, patients with advanced or metastatic solid tumors who have failed orhave no effective standard therapy, and patients who are intolerant to orrefuse standard therapy, given the different tumor species, as determined bythe clinician; 3-2) Dose Extension Study: Cohort 1) Ovarian Cancer: (1)Patients with advanced or metastatic epithelial ovarian cancer, primaryperitoneal cancer, or fallopian tube cancer diagnosed histologically orcytologically with no more than three lines of previous treatment; (2)platinum-resistant recurrent ovarian cancer as defined by the U.S. GynecologicOncology Group (GOG) criteria (disease progression or recurrence confirmed byimaging within 6 months after receiving platinum-containing chemotherapy). ③The expression of FRα in tumor tissue was positive; Cohort 2) Other advancedsolid tumors: (1) Patients with advanced or metastatic solid tumors confirmedhistologically or cytologically, failed or intolerant to standard therapy, wereincluded only in endometrial cancer, breast cancer, and non-small cell lungcancer. ② It can provide tumor tissues to detect FRα expression level; Cohort

  1. Ovarian Cancer: Patients with histologically or cytologically confirmedplatinum-resistant advanced or metastatic epithelial ovarian cancer, primaryperitoneal cancer, or fallopian tube cancer with four or five previous lines oftreatment, platinum-resistant recurrent ovarian cancer as defined by the U.S.Gynecologic Oncology Group (GOG) (imaging confirmation of disease progressionor recurrence within 6 months after receiving platinum-containingchemotherapy). ③ The expression of FRα in tumor tissue was positive.
  1. At least one measurable tumor lesion is present according to RECIST1.1criteria;

  2. The United States Eastern Cancer Consortium (ECOG) requires a score of 0 or 1;

  3. Expected survival assessed by investigators ≥12 weeks;

  4. Have adequate organ and bone marrow reserve function,

  5. Fertile female patients must have a negative serological pregnancy test within 7 days prior to the first dosing and be willing to use an effective birthcontrol/contraceptive method to prevent pregnancy during the study period up to 6 months after the last dosing of the study. Male patients must consent to aneffective contraceptive method during the study period and up to 6 months afterthe last dosing in the study; Postmenopausal women must have amenorrhea for atleast 12 months before they are considered infertile;

  6. Dose escalation study: Willing to provide previously archived or fresh tumortissue samples (if no tumor tissue has been archived in the past, and theresearcher assays that there is a great risk for patients to retake primary ormetastatic tumor tissue samples); Dose expansion studies: Be willing to providepreviously archived or fresh tumor tissue samples that can be used to detectFRα expression levels;

  7. Able to understand the test requirements, willing and able to follow the testand follow-up procedures.

Exclusion

Exclusion Criteria:

  • If you meet any of the following conditions, you will not be allowed to enter thistest:
  1. Have received experimental drug therapy or participated in a clinical study ofa medical device within 4 weeks before the first administration of theinvestigational drug;

  2. Received chemotherapy, radiotherapy, small molecule targeted therapy,biotherapy, endocrine therapy, immunotherapy and other anti-tumor therapywithin 4 weeks before the first use of the investigational drug (if the drug's 5x half-life is less than 28 days, the investigator and sponsor may decidewhether to include the drug based on its pharmacological characteristics afterdiscussion), except for the following: ① nitrosourea or mitomycin C within 6weeks before the first use of the study drug; Oral fluorouracil is taken within 2 weeks prior to the first use of the study drug or within 5 half-lives of thedrug (whichever is longer); (3) Chinese medicine/proprietary Chinese medicinewith clear anti-tumor effects, immunomodulatory drugs (including but notlimited to thymosin, interferon, interleukin, etc.) were systematically treatedwithin 2 weeks before the first use of the investigational drug; (4) Palliativeradiotherapy was performed within 2 weeks before the first use of theinvestigational drug;

  3. Grade ≥3 AE (graded using CTCAE v5.0) that were drug-related or of unknownrelevance after prior treatment with any topoisomerase I inhibitor, such asirinotecan;

  4. Before the first administration of the investigational drug, AE (CTCAE5.0) fromprevious antitumor therapy still had grade 1, except in the following cases: a.Hair loss; b Pigmentation; c. Patients with distal toxicity caused bychemotherapy and radiotherapy who can not be further recovered by judgment; d.stable hypothyroidism with hormone replacement therapy;

  5. Patients who had undergone major surgery or had not recovered from surgerywithin 4 weeks prior to the first administration of the study drug, or hadsignificant trauma, or required elective surgery during the trial period;

  6. Patients with a history of allogeneic cell or solid organ transplantation;

  7. Patients with primary central nervous system tumors or symptomatic centralnervous system metastases, meningeal metastases or a history of epilepsy.Patients with asymptomatic or asymptomatic central nervous system metastasesunder clinical control or who have symptoms but are judged to be stable by theinvestigators can be included, provided that the following conditions are met :a. The clinical symptoms were stable ≥4 weeks before the first dose. b. BrainMRI enhancement showed no evidence of progression of central nervous systemdisease within 4 weeks prior to initial administration; c. Antiepileptic drugshave been stopped ≥2 weeks before the first administration, prednisone dosage ≤10mg/ day or equivalent dose of hormone;

  8. Other active malignancies within 5 years prior to first administration. Exceptlocally cured tumors (e.g. basal cell carcinoma of the skin, squamous cellcarcinoma of the skin, superficial bladder cancer or carcinoma in situ of thebreast, etc.);

  9. The following cardiovascular diseases occurred within 6 months before the firstmedication: New York Heart Association rating (NYHA) for symptomatic heartfailure of grade 2 or higher, left ventricular ejection fraction (LVEF) < 50%,unstable arrhythmia or unstable angina, myocardial infarction requiringtreatment, pulmonary embolism, uncontrolled hypertension (this protocol isdefined as, despite the use of optimal antihypertensive therapy, However,systolic blood pressure > 160mmHg and/or diastolic blood pressure > 100mmHgafter treatment were clinically significant as assessed by the investigator);

  10. Have any other medical condition, physical examination or laboratory resultsthat, in the judgment of the investigator, are unsuitable for the use of theinvestigatory drug;

  11. Patients who have a history of non-infectious pneumonia/pulmonary inflammationrequiring glucocorticoid therapy, or who currently have interstitial lungdisease/pneumonia, or who cannot be ruled out by imaging during the screeningperiod;

  12. Subjects requiring or being treated for tuberculosis, including but not limitedto tuberculosis; Patients who have received standardized anti-tuberculosistreatment and have been confirmed cured by the researchers can be included;

  13. Severe infection within 4 weeks or active infection within 2 weeks prior to thefirst dose;

  14. The presence of persons infected with the following diseases: humanimmunodeficiency virus (HIV); Active hepatitis B virus infection [hepatitis Bsurface antigen (HBsAg) positive, HBV deoxyribonucleic acid (HBV-DNA) test &gt;200 IU/ml or 103 copies /ml]; Hepatitis C virus infection [HCV antibody andviral ribonucleic acid (HCV-RNA) test positive]; Treponema pallidum antibodypositive and RPR positive;

  15. Known hypersensitivity or delayed anaphylaxis to any of the components of theinvestigational drug;

  16. Those who are known to have experienced grade 3 or greater allergic reactionsto macromolecular protein preparations/monoclonal antibodies;

  17. Patients with uncontrolled pleural effusion, pericardial effusion or abdominaleffusion, or who require drainage;

  18. At risk of thrombosis or bleeding:

  19. A cerebrovascular accident or transient ischemic attack occurred within 6months before the first dose;

  20. A history of deep vein thrombosis, pulmonary embolism, or any other severethromboembolism within the 3 months prior to initial administration (implantable intravenous port or catheter-derived thrombosis, orsuperficial venous thrombosis is not considered "severe" thromboembolism);

  21. Any life-threatening bleeding event or grade 3 or 4gastrointestinal/varicose bleeding event requiring blood transfusion,endoscopic or surgical treatment within 3 months prior to initial dosing;

  22. other diseases that the investigator believes have a higher risk of futurebleeding or thrombosis;

  23. The presence of any other serious underlying medical condition (e.g.,uncontrolled diabetes, active gastric ulcers, uncontrolled convulsive attacks,coagulopathy with severe signs or symptoms);

  24. A known history of mental illness, substance abuse, alcohol abuse or drug usethat affected the results of the test;

  25. Women who are pregnant or breastfeeding or women or men who are preparing togive birth;

  26. The patient's compliance to participate in this clinical study is estimated tobe insufficient or the investigator believes that there are other factors thatare not suitable for participation in this study.

Study Design

Total Participants: 216
Treatment Group(s): 1
Primary Treatment: BAT8006 for Injection
Phase: 1
Study Start date:
July 06, 2022
Estimated Completion Date:
December 08, 2025

Study Description

In this multi-center, open, dose-increasing, dose-expanding Phase I clinical study, rapid titration and a "3+3" dose-increasing design were used to explore the safety, tolerability and PK characteristics of BAT8006 for injection in patients with advanced solid tumors. During the dose-escalation test, appropriate doses were selected for the extended study according to the previous study data.

Connect with a study center

  • Anhui Cancer Hospital

    Hefei, Anhui
    China

    Site Not Available

  • Anhui Cancer Hospital

    Hefei 1808722, Anhui 1818058
    China

    Site Not Available

  • Beijing Obstetrics and Gynecology Hospital, Capital Medical University

    Beijing, Beijing
    China

    Site Not Available

  • Beijing Obstetrics and Gynecology Hospital, Capital Medical University

    Beijing 1816670, Beijing Municipality 2038349
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou, Fujian
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou 1810821, Fujian 1811017
    China

    Site Not Available

  • Sun Yat-Sen Memorlal Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong
    China

    Site Not Available

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

    Shenzhen, Guangdong
    China

    Site Not Available

  • Sun Yat-Sen Memorlal Hospital, Sun Yat-Sen University

    Guangzhou 1809858, Guangdong 1809935
    China

    Site Not Available

  • Sun Yat-sen University Cancer Center

    Guangzhou 1809858, Guangdong 1809935
    China

    Site Not Available

  • Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

    Shenzhen 1795565, Guangdong 1809935
    China

    Site Not Available

  • Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute

    Nanning, Guangxi
    China

    Site Not Available

  • Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute

    Nanning 1799869, Guangxi 1809867
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan
    China

    Site Not Available

  • Hubei Cancer Hospital

    Wuhan, Hubei
    China

    Site Not Available

  • Tongji Hospital, Tongji Medical College of Hust

    Wuhan, Hubei
    China

    Active - Recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei
    China

    Active - Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei
    China

    Active - Recruiting

  • Hubei Cancer Hospital

    Wuhan 1791247, Hubei 1806949
    China

    Site Not Available

  • Tongji Hospital, Tongji Medical College of Hust

    Wuhan 1791247, Hubei 1806949
    China

    Site Not Available

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan 1791247, Hubei 1806949
    China

    Site Not Available

  • Zhongnan Hospital of Wuhan University

    Wuhan 1791247, Hubei 1806949
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha, Hunan
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha 1815577, Hunan 1806691
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun 2038180, Jilin 2036500
    China

    Site Not Available

  • Liaoning Cancer Hospital&Institute

    Shenyang, Liaoning
    China

    Site Not Available

  • Liaoning Cancer Hospital&Institute

    Shenyang 2034937, Liaoning 2036115
    China

    Site Not Available

  • Shandong Cancer Hospital

    Jinan, Shandong
    China

    Site Not Available

  • Shandong Cancer Hospital

    Jinan 1805753, Shandong 1796328
    China

    Site Not Available

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi
    China

    Site Not Available

  • Shanxi Provincial Cancer Hospital

    Taiyuan 1793511, Shanxi 1795912
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin 1792947, Tianjin Municipality 1792943
    China

    Site Not Available

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