Advanced Solid TumorsPhase 1NCT05620017
Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BAT8008 for Injection
A Phase 1 study testing BAT8008 for Injection in people with Advanced Solid Tumors, run by Bio-Thera Solutions at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- BAT8008 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 2 sitesChina
- Study dates
- 30 Nov 2022to 31 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All of the following items could be meet to be enrolled the study
- Age ≥18 years old, both sexes;
- Voluntarily sign the informed consent;
- 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.
- According to RECIST1.1, there is at least one measurable tumor lesion;
- The Eastern Collaborative Oncology Group (ECOG) Performance Status score requires a score of 0 or 1;
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- Investigators assessed the expected survival of ≥12 weeks;
- Adequate organ and bone marrow reserve function
- 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;
- Willing to provide previously archived or fresh tumor tissue samples
- Able to understand the test requirements, willing and able to comply with the test and follow-up procedures.
Who cannot join
- If you meet any of the following items, you will not be allowed to enroll this study :
- 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;
- 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);
- 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;
- 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;
- 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;
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- Patients who have received Trop2 targeted therapy previously;
- 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;
- Have a history of allograft cell or solid organ transplantation;
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Zhaohe Wang contact
China2 sites, 2 recruiting
- Recruiting
Affiliated Cancer Hospital of Chongqing University
Chongqing, Chongqing Municipality
Qi Zhou, 86-13708384529, qizhou9128@163.com
Yongsheng Li
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Weihong Tan
Yongling Ji
About this study
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
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.
Read the detailed 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 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.
- Conditions
- Advanced Solid Tumors
- Being tested
- BAT8008 for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAT8008 for InjectionDrug
Also called Recombinant humanized anti Trop2 monoclonal antibody for injection Exetecan conjugate
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.
| Study group | Role | What they receive |
|---|---|---|
| A/0.8mg/kg | Experimental | Drug：BAT8008 for Injection,0.8mg/kg Receives: Drug: BAT8008 for Injection |
| B/1.2mg/kg | Experimental | Drug：BAT8008 for Injection,1.2mg/kg Receives: Drug: BAT8008 for Injection |
| C/2.4mg/kg | Experimental | Drug：BAT8008 for Injection,2.4mg/kg Receives: Drug: BAT8008 for Injection |
| D/3.6mg/kg | Experimental | Drug：BAT8008 for Injection,3.6mg/kg Receives: Drug: BAT8008 for Injection |
| E/4.8mg/kg | Experimental | Drug：BAT8008 for Injection,4.8mg/kg Receives: Drug: BAT8008 for Injection |
| F/6.0mg/kg | Experimental | Drug：BAT8008 for Injection,6.0mg/kg Receives: Drug: BAT8008 for Injection |
| G/7.2mg/kg | Experimental | Drug：BAT8008 for Injection,7.2mg/kg Receives: Drug: BAT8008 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: At the end of Cycle 1( first cycle is 21 days, subsequent cycles are 14 days)
Secondary outcomes (1)
AUC(0-inf)after cycle 6 administration
The area under the concentration-time curve extrapolated from time 0 to infinity
Measured: 91 days after first dose of BAT8008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start30 Nov 2022
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bio-Thera Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weier Song, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620017
- Sponsor's protocol ID
- BAT-8008-001-CR
- Status last verified
- Feb 2026
- First submitted
- 25 Oct 2022
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05620017
- Acronym / sponsor ID
- BAT-8008-001-CR
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Bio-Thera SolutionsIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| A/0.8mg/kg | Experimental | Drug: BAT8008 for InjectionDrug：BAT8008 for Injection,0.8mg/kg |
| B/1.2mg/kg | Experimental | Drug: BAT8008 for InjectionDrug：BAT8008 for Injection,1.2mg/kg |
| C/2.4mg/kg | Experimental | Drug: BAT8008 for InjectionDrug：BAT8008 for Injection,2.4mg/kg |
| D/3.6mg/kg | Experimental | Drug: BAT8008 for InjectionDrug：BAT8008 for Injection,3.6mg/kg |
| E/4.8mg/kg | Experimental | Drug: BAT8008 for InjectionDrug：BAT8008 for Injection,4.8mg/kg |
| F/6.0mg/kg | Experimental | Drug: BAT8008 for InjectionDrug：BAT8008 for Injection,6.0mg/kg |
| G/7.2mg/kg | Experimental | Drug: BAT8008 for InjectionDrug：BAT8008 for Injection,7.2mg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- All of the following items could be meet to be enrolled the study
- Age ≥18 years old, both sexes;
- Voluntarily sign the informed consent;
- 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.
- According to RECIST1.1, there is at least one measurable tumor lesion;
Key exclusion criteria (9 listed)
- 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;
- 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);
- 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;
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAT8008 for InjectionAlso: Recombinant humanized anti Trop2 monoclonal antibody for injection Exetecan conjugateIntravenous 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. | Drug | A/0.8mg/kg, B/1.2mg/kg, C/2.4mg/kg, D/3.6mg/kg, E/4.8mg/kg, F/6.0mg/kg, G/7.2mg/kg |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: 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
Maximum tolerated dose (MTD)
Time frame: 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.
1 secondary outcome
AUC(0-inf)after cycle 6 administration
Time frame: 91 days after first dose of BAT8008
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhaohe Wang contact
Weier Song principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAT8008 for Injection in people with Advanced Solid Tumors, run by Bio-Thera Solutions at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact WeiNing Li (020-31702863（8028）, wnli@bio-thera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: At the end of Cycle 1( first cycle is 21 days, subsequent cycles are 14 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.