> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/evaluate-the-safety-tolerability-and-pharmacokinetic-02240e71-4390-4d2a-82e3-55b137fe5b38 > Record changed: 2026-10-13 # Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BAT8008 for Injection NCT05620017 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) Participants 182 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) Lead sponsor Bio-Thera Solutions Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) Start date 2022-11-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) **Short title** Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BAT8008 for Injection Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) **Official title** A Multicenter, Open Phase I Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Initial Efficacy of BAT8008 for Injection in Patients With Advanced Solid Tumor Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) ## Dates **Completion date** 2027-05-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) **First posted** 2022-11-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) **Registry last updated** 2026-02-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) **Primary completion date** 2027-05-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) **Start date** 2022-11-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) ## Size and sites **Participants** 182 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) **Planned participants** 182 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) **Lead sponsor** Bio-Thera Solutions Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) ## Identifiers **Registry ID** NCT05620017 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) **ClinicalTrials.gov ID** NCT05620017 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) ## Outcomes ### Primary outcomes 1. Dose limiting toxicity (DLT) Timeframe: At the end of Cycle 1( first cycle is 21 days, subsequent cycles are 14 days) 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 2. Maximum tolerated dose (MTD) Timeframe: At the end of Cycle 1( first cycle is 21 days, subsequent cycles are 14 days) 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. ### Secondary outcomes 1. AUC(0-inf)after cycle 6 administration Timeframe: 91 days after first dose of BAT8008 The area under the concentration-time curve extrapolated from time 0 to infinity Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria All of the following items could be meet to be enrolled the study 1. Age ≥18 years old, both sexes; 2. Voluntarily sign the informed consent; 3. 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. 4. According to RECIST1.1, there is at least one measurable tumor lesion; 5. The Eastern Collaborative Oncology Group (ECOG) Performance Status score requires a score of 0 or 1; 6. Investigators assessed the expected survival of ≥12 weeks; 7. Adequate organ and bone marrow reserve function 8. Fertile female patients willing to use effective birth control/contraception to prevent pregnancy during the study period. Male patients must consent to use an effective method of contraception during the study; 9. Willing to provide previously archived or fresh tumor tissue samples 10. Able to understand the test requirements, willing and able to comply with the test and follow-up procedures. ### Exclusion criteria If you meet any of the following items, you will not be allowed to enroll this study : 1. 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; 2. 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); 3. 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; 4. 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; 5. Major surgery (excluding the operation for diagnosis) is required within 4 weeks before the first administration of the study drug or is expected to be performed during the study period; 6. Patients who have received Trop2 targeted therapy previously; 7. Those who have received the treatment containing exatecan or irinotecan and other topoisomerase I inhibitor drugs in the past and have experienced drug related AE ≥ grade 3 or treatment failure of topoisomerase I inhibitor; 8. Have a history of allograft cell or solid organ transplantation; Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) ## Sites - Affiliated Cancer Hospital of Chongqing UniversityChongqing, ChinaRecruiting - Zhejiang Cancer HospitalHangzhou, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05620017) ## Related records ### Drugs (1) - [Delafloxacin](https://trialight.com/data/asset/delafloxacin-70daac65-8439-49a7-b10b-4046284fc0e6.md) ### Lead sponsors (1) - [Bio-Thera Solutions](https://trialight.com/data/company/bio-thera-solutions-f0083db2-9bf0-4f0c-af64-1650c0ec26d2.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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