Advanced Solid TumorsPhase 1/2NCT06341114
A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing BAT8008 injection and BAT1308 injection in people with Advanced Solid Tumors, run by Bio-Thera Solutions at 1 site in China.
Trial summary
The study, led by Zhejiang Cancer Hospital and sponsored by Bio-Thera Solutions, Ltd., is an exploratory multicenter, open-label phase Ib-II clinical trial evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of the combination of BAT8008 with BAT1308 in patients with advanced… 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 injection and BAT1308 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2024to 30 Nov 2026
- Phase
- Phase 1/2
- 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
- Age ≥ 18 years old, gender not specified;
- Voluntary signing of the informed consent form;
- Must be pathologically diagnosed by histology or cytology, with standard treatment failure or absence of standard treatment, intolerance to standard treatment, or refusal of standard treatment for advanced or metastatic epithelial solid tumor patients. Expanded Research Phase: Divided into two cohorts (the sponsor may expand or delete cohorts of tumor types based on real-time study results): Cohort A: Locally advanced or metastatic triple-negative breast cancer diagnosed by histology or cytology, and subjects who cannot be cured by radical resection or radiotherapy, and have used at least one systemic chemotherapy regimen for advanced or metastatic disease. Cohort B: Other advanced or metastatic epithelial solid tumor patients who are intolerant or refuse standard treatment, prioritizing the following types: non-squamous non-small cell lung cancer, gastric adenocarcinoma, esophageal cancer, small cell lung cancer, cervical cancer, and head and neck squamous cell carcinoma.
- According to RECIST 1.1 criteria, there must be evaluable tumor lesions in the dose escalation phase, and at least one measurable tumor lesion in the dose expansion phase;
- Eastern Cooperative Oncology Group (ECOG) performance status score required is 0 or 1;
- Investigator-assessed expected survival period ≥ 12 weeks;
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- Must have sufficient organ and bone marrow reserve function, defined as follows:
- Hematology (no blood transfusions, hematopoietic growth factors, or drugs to correct blood cell counts within 14 days prior to first dose):
- Absolute neutrophil count (ANC) ≥ 1.5 × 10^9 /L Platelet count ≥ 90 × 10^9 /L Hemoglobin ≥ 90 g/L
- Coagulation:
- International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5×ULN (for patients not receiving anticoagulation therapy) Patients receiving oral anticoagulant therapy with an INR of 2~3 can be included
- Liver function:
- Total bilirubin (TBIL) ≤ 1.5×ULN For liver cancer or liver metastases, ≤2×ULN Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN For liver cancer or liver metastases, ≤5×ULN
- Renal function:
- Serum creatinine ≤ 1.5×ULN or estimated glomerular filtration rate > 50 ml/min (using Cockcroft-Gault or modified MDRD formula, see appendix) Urine protein: Urinalysis suggests urine protein < 2+ or urine protein quantification < 1g
- Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose and be willing to use effective contraception methods during the study period until 6 months after the last dose; male patients must agree to use effective contraception methods during the study period until 6 months after the last dose; postmenopausal women must have been amenorrheic for at least 12 months to be considered not of childbearing potential;
- Willing to provide past archived or fresh tumor tissue samples (if there is no archived tumor tissue in the past, and the investigator assesses that there is a significant risk in obtaining fresh or metastatic tumor tissue specimens, exemption may be granted). Immunohistochemical confirmation of PDL1 and Trop2 expression levels is not required before enrollment, but the sponsor requires the collection of biopsy or archived tumor tissue samples to determine PDL1 and Trop2 expression levels;
- Able to understand the requirements of the trial, willing, and able to comply with the trial and follow-up arrangements.
Who cannot join
- Within the first 4 weeks prior to the initial administration of the investigational drug, having received experimental drug therapy or participated in clinical studies of medical devices.
- Within the first 4 weeks prior to the initial administration of the drug, having undergone chemotherapy, curative radiotherapy (palliative radiotherapy should be completed within 2 weeks prior to the initial drug administration), biological therapy, endocrine therapy, immunotherapy, or other anti-tumor treatments; 2) For fluoropyrimidine drugs and small molecule targeted drugs, within 2 weeks prior to the initial administration of the investigational drug or within 5 half-lives of the drug (whichever is longer); 3) Within 42 days prior to the initial administration of the investigational drug for nitrosourea drugs or mitomycin C.
- Having received, within 1 week prior to drug administration, traditional Chinese medicine or treatment explicitly indicated in the drug instructions approved by the NMPA for its anti-tumor functions, or having a clear record in medical history of herbal treatment for anti-tumor purposes.
- Prior anti-tumor therapy resulting in adverse events (AEs) (CTCAE 5.0) still at > Grade 1 before the initial administration of the investigational drug, excluding toxicities judged by the investigator to pose no safety risk, such as alopecia, Grade 2 peripheral neuropathy, etc.
- Needing major surgery within the first 4 weeks prior to the initial administration of the investigational drug (excluding procedures for diagnosis) or anticipated major surgery during the study period.
- Patients who have previously received Trop2-ADC with small molecule toxins that are topoisomerase I inhibitors.
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- Having experienced ≥ Grade 3 immune-related adverse events (irAEs) in the past or having discontinued immunotherapy due to irAEs of any grade.
- Individuals with a history of allogeneic cell or solid organ transplantation.
- Patients with primary central nervous system tumors or symptomatic central nervous system metastases, a history of or currently present meningeal metastases, or a history of seizures. If brain metastases are stable after treatment and there are no new lesions at least 4 weeks before medication, or if asymptomatic lesions are detected for the first time within 4 weeks and the investigator determines disease stability, or if the investigator decides to discontinue corticosteroid treatment 7 days before the initial administration of the investigational drug, then it is allowed.
- Any other active malignant tumors within 5 years before the initial administration of the drug, except for locally cured tumors (such as basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, or ductal carcinoma in situ of the breast).
- Occurrence of the following cardiovascular diseases within 6 months before the initial administration of the drug: symptomatic heart failure of New York Heart Association (NYHA) class 2 or higher, left ventricular ejection fraction (LVEF) <50%, unstable arrhythmias or unstable angina, myocardial infarction requiring treatment, pulmonary embolism, uncontrolled hypertension (defined in this protocol as systolic blood pressure >160mmHg and/or diastolic blood pressure >100mmHg despite optimal antihypertensive therapy, and assessed by the investigator to have clinical significance), QTcF >480ms on 12-lead electrocardiogram (QTcF calculated using the Fridericia correction formula).
- Presence of any other severe underlying diseases (e.g., Gilbert's syndrome, poorly controlled diabetes, active peptic ulcer, unstable controlled seizures, cerebrovascular events/gastrointestinal bleeding within 3 months before the initial administration of the drug, coagulation disorders with severe symptoms or signs), as judged by the investigator to potentially affect the subject's participation in the study, treatment, and follow-up, affect subject compliance, or potentially lead to occurrences of drug-related complications in the subjects.
- History of non-infectious pneumonia/pulmonary inflammation requiring glucocorticoid treatment, current interstitial lung disease (ILD), or subjects in the screening period with suspected ILD/pulmonary inflammation that cannot be ruled out by imaging examinations.
- Patients with a history of autoimmune diseases (except for autoimmune thyroid diseases and type I diabetes that can be treated with hormone replacement therapy).
- Received systemic corticosteroids (prednisone > 10mg/day or equivalent) or other immunosuppressive agents within 14 days prior to the initial use of the investigational drug; exceptions include the following: use of topical, ocular, intra-articular, intranasal, or inhaled corticosteroids, short-term prophylactic use of corticosteroids (duration not exceeding 2 weeks, e.g., for contrast allergy prophylaxis).
- Untreated or actively treated tuberculosis subjects, including but not limited to pulmonary tuberculosis; subjects who have undergone standard anti-tuberculosis treatment and have been confirmed by the investigator to be cured may be included.
- Experienced severe infection within 4 weeks prior to the initial administration of the drug or active infection within 2 weeks.
- Subjects with the following infectious diseases: Human Immunodeficiency Virus (HIV) infection; active Hepatitis B Virus infection [Hepatitis B Surface Antigen (HBsAg) positive, with Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) > 200 IU/ml or 10^3 copies/ml or within the upper limit of normal value determined by the study center]; Hepatitis C Virus infection [HCV antibody and Hepatitis C Virus Ribonucleic Acid (HCV-RNA) positive]; positive syphilis treponemal antibody and RPR/TRUST positive.
- Newly diagnosed thromboembolic events requiring treatment within 6 months (patients with stable lower extremity deep vein thrombosis or port-related thrombosis are allowed to be included).
- Difficult-to-control pleural effusion, pericardial effusion, or ascites requiring repeated drainage surgery (monthly or more frequently).
- Known hypersensitivity reaction or delayed allergic reaction to any component of the investigational drug.
- Known occurrence of ≥ Grade 3 allergic reactions to macromolecular protein preparations/monoclonal antibodies.
- History of mental illness, substance abuse, alcoholism, or drug abuse that may affect trial results.
- Pregnant or lactating women or individuals planning to conceive.
- Other conditions deemed inappropriate for participation in this trial by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Open-label Phase Ib-II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors
The study, led by Zhejiang Cancer Hospital and sponsored by Bio-Thera Solutions, Ltd., is an exploratory multicenter, open-label phase Ib-II clinical trial evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of the combination of BAT8008 with BAT1308 in patients with advanced solid tumors.
This study aims to explore the safety, tolerability, and pharmacokinetic characteristics of BAT8008 combined with BAT1308 in patients with advanced solid tumors, determine the maximum tolerated dose (MTD), provide recommended doses and reasonable dosing regimens for subsequent clinical studies, and preliminarily evaluate the antitumor efficacy.
The study is divided into two stages. The first stage will use a "3+3" dose escalation design to explore the safety and tolerability of the investigational drugs. In the second stage, based on the preliminary safety and efficacy results from the first stage, appropriate doses and tumor types will be selected for expansion studies within the safety dose range to further investigate the safety and clinical efficacy of BAT8008+BAT1308 and provide evidence for subsequent clinical studies.
- Conditions
- Advanced Solid Tumors
- Being tested
- BAT8008 injection, BAT1308 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAT8008 injectionDrug
BAT8008 for injection is a sterile, preservative-free lyophilized powder packaged in vials, with each vial containing 100 mg,Prior to infusion, reconstitute with 5 milliliters of sterile water for injection. After reconstitution, a clear to slightly opalescent, colorless to pale yellow solution with a final concentration of 20 mg/mL can be obtained.
BAT1308 injectionDrug
One vial of 4 mL of concentrate contains 100 mg of BAT1308.
| Study group | Role | What they receive |
|---|---|---|
| A/ Standard 3+3 2.1mg/kg of BAT8008 | Experimental | Drug: BAT8008， Dosage: 2.1mg/kg, Frequency: once every 2 weeks, Duration: 1year Receives: Drug: BAT8008 injection |
| B/ Standard 3+3 2.4mg/kg of BAT8008 | Experimental | Drug: BAT8008， Dosage: 2.4mg/kg, Frequency: once every 2 weeks, Duration: 1year Receives: Drug: BAT8008 injection |
| Standard 3+3 200mg of BAT1308 | Experimental | Drug: BAT1308， Dosage: 200mg, Frequency: once every 2 weeks, Duration: 1year Receives: Drug: BAT1308 injection |
| A/ Standard 3+3 1.8mg/kg of BAT8008 | Experimental | Drug: BAT8008， Dosage: 1.8mg/kg, Frequency: Day1 and Day8，once every 3 weeks, Duration: 1year Receives: Drug: BAT8008 injection |
| B/ Standard 3+3 2.1mg/kg of BAT8008 | Experimental | Drug: BAT8008， Dosage: 2.1mg/kg, Frequency: Day1 and Day8，once every 3 weeks, Duration: 1year Receives: Drug: BAT8008 injection |
| Standard 3+3 300mg of BAT1308 | Experimental | Drug: BAT1308， Dosage: 300mg Frequency: Day1 and Day8，once every 3 weeks, Duration: 1year Receives: Drug: BAT1308 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
DLT events and their incidence.
Measured: The first administration cycle(21 days)
vital signs
Number of participants with abnormal vital signs
Measured: Through study completion, 1 year
Physical examination
Number of participants with abnormal physical examination
Measured: Through study completion, 1 year
Adverse events
Number of cases with all adverse medical events that occur after the subject receives the investigational drug assessed by CTCAE V5.0
Measured: From the first receipt of the investigational drug until 28 (+7) days after the last receipt of the investigational drug or the initiation of a new antitumor therapy, whichever occurs earlier，assessed up to 1 year
Clinical laboratory tests
Number of participants with abnormal clinical laboratory tests
Measured: Through study completion, 1 year
Clinical auxiliary tests
Number of participants with abnormal clinical auxiliary tests
Measured: Through study completion, 1 year
Objective response rate (ORR)
Refer to the proportion of subjects defined as complete remission (CR) and partial remission (PR)
Measured: Through study completion, 1 year
Duration of Response(DOR)
DoR is defined as the time between the first assessment of objective remission of a tumor and death from any cause before the first assessment of Disease progression (PD) , reflecting the duration of ORR.
Measured: Through study completion, 1 year
Disease Control Rate (DCR)
The proportion of patients with tumor reduction or stability maintained for a certain period, including cases of complete response (CR), partial response (PR), and stable disease (SD).
Measured: Through study completion, 1 year
Progression Free Survival(PFS)
Progression Free Survival（PFS ）in patients with advanced or recurrent dMMR endometrial cancer treated with BAT1308 combined with platinum-containing chemotherapy were compared with platinum-containing chemotherapy in first-line treatment by IRC according to RECIST V1.1.
Measured: Through study completion, 1 year
Overall Survival(OS)
The time from the date of first administration to the occurrence of death due to any cause. Subjects who were still alive at the time of analysis will use the date of their last contact as the deadline.
Measured: Through study completion, 1 year
Secondary outcomes (6)
Pharmacokinetic
Level of Tmax
Measured: At the end of Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1), Cycle 3 Day 1 (C3D1), Cycle 3 Day 2 (C3D2), Cycle 3 Day 3 (C3D3), Cycle 3 Day 8 (C3D8), Cycle 4 Day 1 (C4D1), after Cycle4, Every 4 cycle until 26 cycles (one cycle equals 2 weeks).
Pharmacokinetic
Level of CL
Measured: At the end of Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1), Cycle 3 Day 1 (C3D1), Cycle 3 Day 2 (C3D2), Cycle 3 Day 3 (C3D3), Cycle 3 Day 8 (C3D8), Cycle 4 Day 1 (C4D1), after Cycle4, Every 4 cycle until 26 cycles (one cycle equals 2 weeks).
Pharmacokinetic
Level of T1/2
Measured: At the end of Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1), Cycle 3 Day 1 (C3D1), Cycle 3 Day 2 (C3D2), Cycle 3 Day 3 (C3D3), Cycle 3 Day 8 (C3D8), Cycle 4 Day 1 (C4D1), after Cycle4, Every 4 cycle until 26 cycles (one cycle equals 2 weeks).
Pharmacokinetic
Level of Cmax
Measured: At the end of Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1), Cycle 3 Day 1 (C3D1), Cycle 3 Day 2 (C3D2), Cycle 3 Day 3 (C3D3), Cycle 3 Day 8 (C3D8), Cycle 4 Day 1 (C4D1), after Cycle4, Every 4 cycle until 26 cycles (one cycle equals 2 weeks).
Pharmacokinetic
Level of ADA
Measured: At the end of Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1), Cycle 3 Day 1 (C3D1), Cycle 3 Day 2 (C3D2), Cycle 3 Day 3 (C3D3), Cycle 3 Day 8 (C3D8), Cycle 4 Day 1 (C4D1), after Cycle4, Every 4 cycle until 26 cycles (one cycle equals 2 weeks).
Pharmacokinetic
Level of Nab
Measured: At the end of Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1), Cycle 3 Day 1 (C3D1), Cycle 3 Day 2 (C3D2), Cycle 3 Day 3 (C3D3), Cycle 3 Day 8 (C3D8), Cycle 4 Day 1 (C4D1), after Cycle4, Every 4 cycle until 26 cycles (one cycle equals 2 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start12 Apr 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bio-Thera Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341114
- Sponsor's protocol ID
- BAT-8008-1308-001-CR
- Status last verified
- Sep 2026
- First submitted
- 14 Mar 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Phase Ib-II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06341114
- Acronym / sponsor ID
- BAT-8008-1308-001-CR
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Bio-Thera SolutionsIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 2 Apr 2024 (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.
The study, led by Zhejiang Cancer Hospital and sponsored by Bio-Thera Solutions, Ltd., is an exploratory multicenter, open-label phase Ib-II clinical trial evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of the combination of BAT8008 with BAT1308 in patients with advanced solid tumors.
This study aims to explore the safety, tolerability, and pharmacokinetic characteristics of BAT8008 combined with BAT1308 in patients with advanced solid tumors, determine the maximum tolerated dose (MTD), provide recommended doses and reasonable dosing regimens for subsequent clinical studies, and preliminarily evaluate the antitumor efficacy.
The study is divided into two stages. The first stage will use a "3+3" dose escalation design to explore the safety and tolerability of the investigational drugs. In the second stage, based on the preliminary safety and efficacy results from the first stage, appropriate doses and tumor types will be selected for expansion studies within the safety dose range to further investigate the safety and clinical efficacy of BAT8008+BAT1308 and provide evidence for subsequent clinical studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A/ Standard 3+3 2.1mg/kg of BAT8008 | Experimental | Drug: BAT8008 injectionDrug: BAT8008， Dosage: 2.1mg/kg, Frequency: once every 2 weeks, Duration: 1year |
| B/ Standard 3+3 2.4mg/kg of BAT8008 | Experimental | Drug: BAT8008 injectionDrug: BAT8008， Dosage: 2.4mg/kg, Frequency: once every 2 weeks, Duration: 1year |
| Standard 3+3 200mg of BAT1308 | Experimental | Drug: BAT1308 injectionDrug: BAT1308， Dosage: 200mg, Frequency: once every 2 weeks, Duration: 1year |
| A/ Standard 3+3 1.8mg/kg of BAT8008 | Experimental | Drug: BAT8008 injectionDrug: BAT8008， Dosage: 1.8mg/kg, Frequency: Day1 and Day8，once every 3 weeks, Duration: 1year |
| B/ Standard 3+3 2.1mg/kg of BAT8008 | Experimental | Drug: BAT8008 injectionDrug: BAT8008， Dosage: 2.1mg/kg, Frequency: Day1 and Day8，once every 3 weeks, Duration: 1year |
| Standard 3+3 300mg of BAT1308 | Experimental | Drug: BAT1308 injectionDrug: BAT1308， Dosage: 300mg Frequency: Day1 and Day8，once every 3 weeks, Duration: 1year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age ≥ 18 years old, gender not specified;
- Voluntary signing of the informed consent form;
- Must be pathologically diagnosed by histology or cytology, with standard treatment failure or absence of standard treatment, intolerance to standard treatment, or refusal of standard treatment for advanced or metastatic epithelial solid tumor patients. Expanded Research Phase: Divided into two cohorts (the sponsor may expand or delete cohorts of tumor types based on real-time study results): Cohort A: Locally advanced or metastatic triple-negative breast cancer diagnosed by histology or cytology, and subjects who cannot be cured by radical resection or radiotherapy, and have used at least one systemic chemotherapy regimen for advanced or metastatic disease. Cohort B: Other advanced or metastatic epithelial solid tumor patients who are intolerant or refuse standard treatment, prioritizing the following types: non-squamous non-small cell lung cancer, gastric adenocarcinoma, esophageal cancer, small cell lung cancer, cervical cancer, and head and neck squamous cell carcinoma.
- According to RECIST 1.1 criteria, there must be evaluable tumor lesions in the dose escalation phase, and at least one measurable tumor lesion in the dose expansion phase;
- Eastern Cooperative Oncology Group (ECOG) performance status score required is 0 or 1;
Key exclusion criteria (25 listed)
- Within the first 4 weeks prior to the initial administration of the investigational drug, having received experimental drug therapy or participated in clinical studies of medical devices.
- Within the first 4 weeks prior to the initial administration of the drug, having undergone chemotherapy, curative radiotherapy (palliative radiotherapy should be completed within 2 weeks prior to the initial drug administration), biological therapy, endocrine therapy, immunotherapy, or other anti-tumor treatments; 2) For fluoropyrimidine drugs and small molecule targeted drugs, within 2 weeks prior to the initial administration of the investigational drug or within 5 half-lives of the drug (whichever is longer); 3) Within 42 days prior to the initial administration of the investigational drug for nitrosourea drugs or mitomycin C.
- Having received, within 1 week prior to drug administration, traditional Chinese medicine or treatment explicitly indicated in the drug instructions approved by the NMPA for its anti-tumor functions, or having a clear record in medical history of herbal treatment for anti-tumor purposes.
- Prior anti-tumor therapy resulting in adverse events (AEs) (CTCAE 5.0) still at > Grade 1 before the initial administration of the investigational drug, excluding toxicities judged by the investigator to pose no safety risk, such as alopecia, Grade 2 peripheral neuropathy, etc.
- Needing major surgery within the first 4 weeks prior to the initial administration of the investigational drug (excluding procedures for diagnosis) or anticipated major surgery 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 injectionBAT8008 for injection is a sterile, preservative-free lyophilized powder packaged in vials, with each vial containing 100 mg,Prior to infusion, reconstitute with 5 milliliters of sterile water for injection. After reconstitution, a clear to slightly opalescent, colorless to pale yellow solution with a final concentration of 20 mg/mL can be obtained. | Drug | A/ Standard 3+3 1.8mg/kg of BAT8008, A/ Standard 3+3 2.1mg/kg of BAT8008, B/ Standard 3+3 2.1mg/kg of BAT8008, B/ Standard 3+3 2.4mg/kg of BAT8008 |
| BAT1308 injectionOne vial of 4 mL of concentrate contains 100 mg of BAT1308. | Drug | Standard 3+3 200mg of BAT1308, Standard 3+3 300mg of BAT1308 |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: The first administration cycle(21 days)
DLT events and their incidence.
vital signs
Time frame: Through study completion, 1 year
Number of participants with abnormal vital signs
Physical examination
Time frame: Through study completion, 1 year
Number of participants with abnormal physical examination
Adverse events
Time frame: From the first receipt of the investigational drug until 28 (+7) days after the last receipt of the investigational drug or the initiation of a new antitumor therapy, whichever occurs earlier，assessed up to 1 year
Number of cases with all adverse medical events that occur after the subject receives the investigational drug assessed by CTCAE V5.0
Clinical laboratory tests
Time frame: Through study completion, 1 year
Number of participants with abnormal clinical laboratory tests
Clinical auxiliary tests
Time frame: Through study completion, 1 year
Number of participants with abnormal clinical auxiliary tests
Objective response rate (ORR)
Time frame: Through study completion, 1 year
Refer to the proportion of subjects defined as complete remission (CR) and partial remission (PR)
Duration of Response(DOR)
Time frame: Through study completion, 1 year
DoR is defined as the time between the first assessment of objective remission of a tumor and death from any cause before the first assessment of Disease progression (PD) , reflecting the duration of ORR.
Disease Control Rate (DCR)
Time frame: Through study completion, 1 year
The proportion of patients with tumor reduction or stability maintained for a certain period, including cases of complete response (CR), partial response (PR), and stable disease (SD).
Progression Free Survival(PFS)
Time frame: Through study completion, 1 year
Progression Free Survival（PFS ）in patients with advanced or recurrent dMMR endometrial cancer treated with BAT1308 combined with platinum-containing chemotherapy were compared with platinum-containing chemotherapy in first-line treatment by IRC according to RECIST V1.1.
Overall Survival(OS)
Time frame: Through study completion, 1 year
The time from the date of first administration to the occurrence of death due to any cause. Subjects who were still alive at the time of analysis will use the date of their last contact as the deadline.
6 secondary outcomes
Pharmacokinetic
Time frame: At the end of Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1), Cycle 3 Day 1 (C3D1), Cycle 3 Day 2 (C3D2), Cycle 3 Day 3 (C3D3), Cycle 3 Day 8 (C3D8), Cycle 4 Day 1 (C4D1), after Cycle4, Every 4 cycle until 26 cycles (one cycle equals 2 weeks).
Pharmacokinetic
Time frame: At the end of Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1), Cycle 3 Day 1 (C3D1), Cycle 3 Day 2 (C3D2), Cycle 3 Day 3 (C3D3), Cycle 3 Day 8 (C3D8), Cycle 4 Day 1 (C4D1), after Cycle4, Every 4 cycle until 26 cycles (one cycle equals 2 weeks).
Pharmacokinetic
Time frame: At the end of Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1), Cycle 3 Day 1 (C3D1), Cycle 3 Day 2 (C3D2), Cycle 3 Day 3 (C3D3), Cycle 3 Day 8 (C3D8), Cycle 4 Day 1 (C4D1), after Cycle4, Every 4 cycle until 26 cycles (one cycle equals 2 weeks).
Pharmacokinetic
Time frame: At the end of Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1), Cycle 3 Day 1 (C3D1), Cycle 3 Day 2 (C3D2), Cycle 3 Day 3 (C3D3), Cycle 3 Day 8 (C3D8), Cycle 4 Day 1 (C4D1), after Cycle4, Every 4 cycle until 26 cycles (one cycle equals 2 weeks).
Pharmacokinetic
Time frame: At the end of Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1), Cycle 3 Day 1 (C3D1), Cycle 3 Day 2 (C3D2), Cycle 3 Day 3 (C3D3), Cycle 3 Day 8 (C3D8), Cycle 4 Day 1 (C4D1), after Cycle4, Every 4 cycle until 26 cycles (one cycle equals 2 weeks).
Pharmacokinetic
Time frame: At the end of Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1), Cycle 3 Day 1 (C3D1), Cycle 3 Day 2 (C3D2), Cycle 3 Day 3 (C3D3), Cycle 3 Day 8 (C3D8), Cycle 4 Day 1 (C4D1), after Cycle4, Every 4 cycle until 26 cycles (one cycle equals 2 weeks).
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 2 Oct 2026.
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A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BAT8008 injection and BAT1308 injection in people with Advanced Solid Tumors, run by Bio-Thera Solutions at 1 site 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 18 inclusion and 25 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: The first administration cycle(21 days)). The study lists 11 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 2 Oct 2026.