Solid TumorPhase 1/2NCT04151329
A Phase I Clinical Trial of BAT1306 and BAT8001 Injection in Patients With Solid Tumor
A Phase 1/2 study testing BAT1306 and BAT8001 2.4mg/kg and BAT1306 and BAT8001 3.6mg/kg in people with Solid Tumor, run by Bio-Thera Solutions at 1 site in China.
Trial summary
A Phase I Clinical Trial of BAT1306 and BAT8001 Injection in Patients With HER2-positive Advanced Solid Tumor Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- BAT1306 and BAT8001 2.4mg/kg and BAT1306 and BAT8001 3.6mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 21 Jun 2019to 30 Jun 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 (inclusive) years old male and female;
- Patients with advanced malignant solid tumors confirmed by histology or cytology, who have failed standard treatment, or who have no standard treatment plan, or who are not suitable for standard treatment at this stage;
- Confirmed by the test as HER2 positive, defined as: IHC 3+ or ISH +;
- ECOG physical status score 0-1 points;
- Estimated survival time of more than 3 months;
- According to RECIST version 1.1, there is at least one measurable tumor lesion;
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- Have adequate organ function: (1) Blood system (no blood transfusion or colony stimulating factor (G-CSF) treatment within 14 days): Neutrophil absolute value (ANC) ≥1.5×10^9/L; Platelet (PLT) ≥100×10^9/L; Hemoglobin (Hb) ≥90g/L; (2) liver function: Total bilirubin (TBIL) ≤1.5×ULN; Alanine aminotransferase (ALT) ≤ 2.5 × ULN; Aspartate aminotransferase (AST) ≤ 2.5 × ULN; (3) Renal function: Creatinine (Cr) ≤ 1.5 × ULN; Creatinine clearance (CCr) >50ml/min (calculated according to Cockcroft-Gault formula); Coagulation; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; International normalized ratio (INR) ≤ 1.5 × ULN; Myocardial zymogram; Troponin T <1×ULN;
- Qualified patients (male and female) with fertility must agree to use reliable methods of contraception (hormone or barrier or abstinence) during the trial period and at least 6 months after the last dose; female patients of childbearing age are selected before the election. The blood pregnancy test within the day must be negative;
- Subjects must give informed consent to the study prior to the trial and voluntarily sign a written informed consent form.
Who cannot join
- Receive anti-tumor therapy such as radiotherapy, chemotherapy, targeted therapy, endocrine therapy or immunotherapy within 4 weeks before the first dose, or other clinical trial drug treatment; Note: Immunological checkpoint inhibitors, including anti-PD-1 antibody, anti-PD-L1 antibody, mitomycin and nitrosourea for 6 weeks from the last dose; fluorouracil oral drugs such as tegao, card Peitabin is within 2 weeks of taking the last dose; 2. The cumulative dose of anthracycline used in the past meets any of the following values: Doxorubicin or liposomal doxorubicin >360mg/m2 ? Epirubicin > 540mg/m2 ? Mitoxantrone > 84mg/m2
- If another anthracycline or more than one anthracycline is used, the cumulative dose exceeds the equivalent dose of doxorubicin 360 mg/m2
- Have undergone major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first dose; subcutaneous venous access device implantation (eg PICC) within 7 days;
- Need to be combined during the trial, or 1 week before the first dose (or 3 half-lives of the drug, whichever is longer), have received strong inducers or strong inhibitors of CYP3A4 (see Appendix 7);
- Adverse reactions to previous anti-tumor treatment have not been restored to CTCAE 5.0 grade evaluation ≤ 1 (except for hair loss);
- Brain metastases with clinical symptoms, spinal cord compression, cancerous meningitis, or other evidence that the central nervous system metastases in patients have not been controlled, the researchers judged that it is not suitable for enrollment; patients with clinical symptoms suspected of brain or pia mater Need to be excluded by CT / MRI examination; 7.
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- There have been ≥3 immune-related adverse events (irAE, see Appendix 5) in immunotherapy.
- Patients with active or pre-existing autoimmune diseases that may have recurrence (eg, systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.); 9. Patients who have received systemic corticosteroids (prednisone >10 mg/day or equivalent dose of the same drug) or other immunosuppressive agents within 14 days prior to the first dose; Except for the use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term use of corticosteroids for prophylaxis, such as the use of contrast agents;
- 10. Currently or have had interstitial lung disease; 11. There are uncontrolled active infections; 12. Have a history of immunodeficiency, including HIV antibody test positive; 13. Active hepatitis B patients (hepatitis B virus titer is higher than the lower limit of detection), allowing prophylactic antiviral therapy other than interferon; hepatitis C virus infection (anti-hepatitis C antibody positive or hepatitis C RNA) Positive); 14. There are ≥2 grade peripheral neuropathy; 15. Have a history of serious cardiovascular disease: ? Ventricular arrhythmias requiring clinical intervention; Acute coronary syndrome, congestive heart failure, stroke, thromboembolic events, or other cardiovascular events of grade 3 or above within 6 months prior to enrollment; 15.New York Heart Association (NYHA) cardiac function classification ≥ II or left ventricular ejection fraction (LVEF) < 50%; 16. Hypertension that cannot be controlled by a single drug (systolic blood pressure after treatment >140 mmHg and/or diastolic blood pressure >90 mmHg); 16. Known to be allergic to trastuzumab or other anti-PD-1, anti-PD-L1 monoclonal antibody drugs; 17. Alcohol or drug dependence is known; 18. Persons with mental disorders or poor compliance; 19. Women during pregnancy or lactation; 20. The investigator believes that the subject has any clinical or laboratory abnormalities or other reasons that are not suitable for participation in this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site
Medical Ethics Committee of Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
About this study
Official title: Evaluation for the Safety of BAT1306 and BAT8001 Injection for the Treatment of Patients With HER2-positive Advanced Solid Tumors Phase I/IIa Clinical Trials of Sexual, Tolerability and Pharmacokinetic Characteristics
A Phase I Clinical Trial of BAT1306 and BAT8001 Injection in Patients With HER2-positive Advanced Solid Tumor
Read the detailed description
main purpose: To evaluate the safety and tolerability of BAT8001 in combination with BAT1306 in patients with HER2-positive advanced solid tumors, and to explore the maximum tolerated dose (MTD) to determine the recommended dose for phase II clinical trials (RP2D). Secondary purpose: (1) Evaluation of pharmacokinetic (PK) and immunogenic characteristics of BAT8001 in combination with BAT1306. (2) Preliminary evaluation of the antitumor efficacy of BAT8001 in combination with BAT1306. Exploratory purpose: To explore the efficacy-related biomarkers of BAT8001 in combination with BAT1306 in the treatment of patients with advanced solid tumors.
- Conditions
- Solid Tumor
- Being tested
- BAT1306 and BAT8001 2.4mg/kg, BAT1306 and BAT8001 3.6mg/kg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAT1306 and BAT8001 2.4mg/kgBiological
Phase 1 dose titration study of BAT1306 and BAT8001 2.4mg/kg , then choose a proper dose for amplification study based on DLT result
BAT1306 and BAT8001 3.6mg/kgBiological
Phase 1 dose titration study of BAT1306 and BAT8001 3.6mg/kg , then choose a proper dose for amplification study based on DLT result
| Study group | Role | What they receive |
|---|---|---|
| 2.4mg/kg of BAT8001 | Experimental | Drug:BAT1306 100mg/4ml/box, 200mg IV infusions ,BAT8001 100mg/box, 2.4mg/kg IV infusions Receives: Biological: BAT1306 and BAT8001 2.4mg/kg |
| 3.6mg/kg of BAT8001 | Experimental | Drug:BAT1306 100mg/4ml/box, 200mg IV infusions ,BAT8001 100mg/box,3.6mg/kg IV infusions Receives: Biological: BAT1306 and BAT8001 3.6mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity（DLT）
Safety and tolerability endpoint
Measured: 3weeks
Area under the curve (AUC)
Pharmacokinetic endpoint
Measured: 3weeks
Maximum serum drug concentration (Cmax)
Pharmacokinetic endpoint
Measured: 3weeks
Half-life period(t1/2)
Pharmacokinetic endpoint
Measured: 3weeks
Anti drug antibodies (ADA)
Plasma level of anti drug antibodies (ADA) correlated with bevacizumab plasma level
Measured: through study completion, an average between half year and a year
Neutralizing anti-drug antibodies (NADA)
Neutralizing anti-drug antibodies (NADA) correlated with bevacizumab plasma level
Measured: through study completion, an average between half year and a year
Secondary outcomes (4)
ORR
Overall response rate
Measured: through study completion, an average between half year and a year
PFS
Progression free survival time
Measured: through study completion, an average between half year and a year
DCR
Disease control rate
Measured: through study completion, an average between half year and a year
DOR
Duration of response
Measured: through study completion, an average between half year and a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start21 Jun 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 72 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
- NCT04151329
- Sponsor's protocol ID
- BAT-8001+1306-001GC-CR
- Status last verified
- Jun 2019
- First submitted
- 30 Oct 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation for the Safety of BAT1306 and BAT8001 Injection for the Treatment of Patients With HER2-positive Advanced Solid Tumors Phase I/IIa Clinical Trials of Sexual, Tolerability and Pharmacokinetic Characteristics
- ClinicalTrials.gov ID
- NCT04151329
- Acronym / sponsor ID
- BAT-8001+1306-001GC-CR
- Conditions
- Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Bio-Thera SolutionsIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 5 Nov 2019 (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.
A Phase I Clinical Trial of BAT1306 and BAT8001 Injection in Patients With HER2-positive Advanced Solid Tumor
Detailed description
main purpose: To evaluate the safety and tolerability of BAT8001 in combination with BAT1306 in patients with HER2-positive advanced solid tumors, and to explore the maximum tolerated dose (MTD) to determine the recommended dose for phase II clinical trials (RP2D). Secondary purpose: (1) Evaluation of pharmacokinetic (PK) and immunogenic characteristics of BAT8001 in combination with BAT1306. (2) Preliminary evaluation of the antitumor efficacy of BAT8001 in combination with BAT1306. Exploratory purpose: To explore the efficacy-related biomarkers of BAT8001 in combination with BAT1306 in the treatment of patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2.4mg/kg of BAT8001 | Experimental | Biological: BAT1306 and BAT8001 2.4mg/kgDrug:BAT1306 100mg/4ml/box, 200mg IV infusions ,BAT8001 100mg/box, 2.4mg/kg IV infusions |
| 3.6mg/kg of BAT8001 | Experimental | Biological: BAT1306 and BAT8001 3.6mg/kgDrug:BAT1306 100mg/4ml/box, 200mg IV infusions ,BAT8001 100mg/box,3.6mg/kg IV infusions |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18 to 75 (inclusive) years old male and female;
- Patients with advanced malignant solid tumors confirmed by histology or cytology, who have failed standard treatment, or who have no standard treatment plan, or who are not suitable for standard treatment at this stage;
- Confirmed by the test as HER2 positive, defined as: IHC 3+ or ISH +;
- ECOG physical status score 0-1 points;
- Estimated survival time of more than 3 months;
Key exclusion criteria (9 listed)
- Receive anti-tumor therapy such as radiotherapy, chemotherapy, targeted therapy, endocrine therapy or immunotherapy within 4 weeks before the first dose, or other clinical trial drug treatment; Note: Immunological checkpoint inhibitors, including anti-PD-1 antibody, anti-PD-L1 antibody, mitomycin and nitrosourea for 6 weeks from the last dose; fluorouracil oral drugs such as tegao, card Peitabin is within 2 weeks of taking the last dose; 2. The cumulative dose of anthracycline used in the past meets any of the following values: Doxorubicin or liposomal doxorubicin >360mg/m2 ? Epirubicin > 540mg/m2 ? Mitoxantrone > 84mg/m2
- If another anthracycline or more than one anthracycline is used, the cumulative dose exceeds the equivalent dose of doxorubicin 360 mg/m2
- Have undergone major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first dose; subcutaneous venous access device implantation (eg PICC) within 7 days;
- Need to be combined during the trial, or 1 week before the first dose (or 3 half-lives of the drug, whichever is longer), have received strong inducers or strong inhibitors of CYP3A4 (see Appendix 7);
- Adverse reactions to previous anti-tumor treatment have not been restored to CTCAE 5.0 grade evaluation ≤ 1 (except for hair loss);
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 |
|---|---|---|
| BAT1306 and BAT8001 2.4mg/kgPhase 1 dose titration study of BAT1306 and BAT8001 2.4mg/kg , then choose a proper dose for amplification study based on DLT result | Biological | 2.4mg/kg of BAT8001 |
| BAT1306 and BAT8001 3.6mg/kgPhase 1 dose titration study of BAT1306 and BAT8001 3.6mg/kg , then choose a proper dose for amplification study based on DLT result | Biological | 3.6mg/kg of BAT8001 |
Primary outcome
Dose-limiting toxicity（DLT）
Time frame: 3weeks
Safety and tolerability endpoint
Area under the curve (AUC)
Time frame: 3weeks
Pharmacokinetic endpoint
Maximum serum drug concentration (Cmax)
Time frame: 3weeks
Pharmacokinetic endpoint
Half-life period(t1/2)
Time frame: 3weeks
Pharmacokinetic endpoint
Anti drug antibodies (ADA)
Time frame: through study completion, an average between half year and a year
Plasma level of anti drug antibodies (ADA) correlated with bevacizumab plasma level
Neutralizing anti-drug antibodies (NADA)
Time frame: through study completion, an average between half year and a year
Neutralizing anti-drug antibodies (NADA) correlated with bevacizumab plasma level
4 secondary outcomes
ORR
Time frame: through study completion, an average between half year and a year
PFS
Time frame: through study completion, an average between half year and a year
DCR
Time frame: through study completion, an average between half year and a year
DOR
Time frame: through study completion, an average between half year and a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Individual participant dataSharing planned: Undecided. Undecided
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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 BAT1306 and BAT8001 2.4mg/kg and BAT1306 and BAT8001 3.6mg/kg in people with Solid Tumor, 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 9 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: status not confirmed, as of the sponsor's last update on 5 Nov 2019. 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?
Results are not available in the source record.
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: 3weeks). The study lists 6 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 5 Nov 2019.