A Phase 1 interventional study of BAT8008 for Injection in Advanced Solid Tumors, sponsored by Bio-Thera Solutions. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.
Sponsored by Bio-Thera Solutions · Phase 1, Interventional, and Treatment
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.
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 BAT8008 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.
Bio-Thera Solutions is the lead sponsor of 57 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All of the following items could be meet to be enrolled the study
Exclusion Criteria:
If you meet any of the following items, you will not be allowed to enroll this study :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug:BAT8008 for Injection,0.8mg/kg
Drug: BAT8008 for Injection
Drug:BAT8008 for Injection,1.2mg/kg
Drug: BAT8008 for Injection
Drug:BAT8008 for Injection,2.4mg/kg
Drug: BAT8008 for Injection
Drug:BAT8008 for Injection,3.6mg/kg
Drug: BAT8008 for Injection
Drug:BAT8008 for Injection,4.8mg/kg
Drug: BAT8008 for Injection
Drug:BAT8008 for Injection,6.0mg/kg
Drug: BAT8008 for Injection
Drug:BAT8008 for Injection,7.2mg/kg
Drug: BAT8008 for Injection
Intravenous 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.
Also known as: Recombinant humanized anti Trop2 monoclonal antibody for injection Exetecan conjugate
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)
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)
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 BAT8008
Presence of ADA/nentralizing antibodies(NAbs)
presence of anti-drug antibody/ nentralizing antibodies
Time frame: 91 days after first dose of BAT8008
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