Evaluating the Safety, Tolerability, and Pharmacokinetics of BAT1006

A Phase 1 study testing BAT1006 in people with Advanced Solid Tumor, run by Bio-Thera Solutions at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Primary objectives: To evaluate the safety and tolerability of BAT1006 in patients with advanced her2-positive solid tumors. To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT). Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Advanced Solid Tumor
What is being tested?: BAT1006
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 2 sitesChina
Study dates: 10 Feb 2022to 17 Jun 2024
Phase: Phase 1
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The patient or his legal representative signs the informed consent, fully understands the content, process and possible adverse reactions of the trial, and is willing to conduct follow-up and imaging evaluation in accordance with the time specified in the trial;
Age 18-80 years old (including boundary value), gender is not limited;
Patients with locally advanced or metastatic solid tumors confirmed by histopathology and/or cytology as HER2-positive. The extended study was limited to patients with HER2-positive locally advanced or metastatic breast and stomach cancer. Her2-positive (HER2-positive defined as IHC3+ or FISH+);
Patients with no effective treatment or failure of standard treatment;
Tumor with at least one measurable lesion according to Recist version 1.1 criteria;
United States Eastern Oncology Collaboration (ECOG) physical status score 0-1;

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Expected survival ≥3 months;
Have sufficient bone marrow, liver, kidney and blood clotting function,
Left ventricular ejection fraction (LVEF) ≥55% by echocardiography;
Fertile female patients must have a negative serological pregnancy test prior to first dosing and be willing to use an effective birth control/contraceptive method to prevent pregnancy during the study period up to 6 months after the last dosing of the study. Male patients must consent to an effective contraceptive method for the duration of the study up to 6 months after the last dosing in the study.

Who cannot join

Previous doxorubicin cumulative dose \> Subjects with 360 mg/m2 or equivalent anthracyclines;
Previous treatment with trastuzumab, pertuzumab, or other HER2-targeted drugs (including but not limited to grade 3 or higher infusion reactions or allergic reactions, LVEF < 50% after treatment, or grade 3 or higher diarrhea);
The toxic effects of previous antitumor therapy have not returned to grade 0 to 1 as defined in CTCAE version 5.0, except for alopecia, pigmentation and anemia;
Patients who have received other anti-tumor therapy, such as chemotherapy, radiotherapy (but for palliative radiotherapy within 2 weeks before the first dose), biological products, etc., within 4 weeks of the first dose (targeted therapy/immunotherapy with a minimum interval of 4 weeks or at least 5 half-lives, whichever is shorter; Within 6 weeks before administration of nitrosourea and mitomycin C, within 2 weeks before administration of oral fluorouracil, within 1 week before administration of NMPA-approved Chinese patent medicine or treatment clearly with anti-tumor related functions, or Chinese herbal therapy clearly recorded in the medical records for anti-tumor purposes);
The presence of ≥2 grade peripheral neuropathy (CTCAE5.0 grade);
Pregnant or nursing women;

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Patients with CNS metastases that are symptomatic or require ongoing treatment, but asymptomatic and radiologically stable for more than 4 weeks without the need for corticosteroid treatment could be enrolled;
Patients with active infection prior to initial administration and currently in need of intravenous anti-infective therapy;
Patients infected with any of the following viruses: active hepatitis B (HBsAg (+), with HBV DNA > 500IU/ml or the maximum hospital limit); Active hepatitis C (HCV antibody positive and HCV-RNA levels above the lower limit of detection); HIV infection; Active syphilis infection (RPR positive);
Have active pneumonia/interstitial lung disease (ILD), a history of pneumonia/interstitial lung disease requiring systemic steroid treatment, have received lung radiation within 12 months prior to the first administration of the study drug, or currently have clinically relevant lung disease (such as chronic obstructive pulmonary disease);
Active autoimmune diseases requiring systemic treatment (such as the use of disease-regulating drugs, corticosteroids, or immunosuppressive drugs), allowing for relevant replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency);
Serious signs and symptoms accompanied by other concurrent, severe, or uncontrollable systemic diseases, including but not limited to: active gastric ulcers, uncontrolled epilepsy, cerebrovascular accidents, gastrointestinal bleeding, blood clotting and coagulation disorders;
Cardiovascular abnormalities within the first 6 months of enrollment according to any of the following definitions: Based on the CTCAE5.0 standard grade ≥3 symptomatic congestive heart failure (CHF), or the New York Heart Society (NYHA) standard grade ≥2 symptomatic congestive heart failure, transmastic myocardial infarction, and unstable angina pectoris, Or severe arrhythmia, severe conduction block, poorly controlled hypertension (blood pressure after medication \> 150/100 MMHG), or other clinically significant cardiovascular disease;
Have participated in and received other clinical trials within 4 weeks before the first dose;
Received any live virus vaccine within 4 weeks prior to the first dose;
Have received major surgical treatment within 4 weeks prior to the first dose and have not fully recovered;
Known or suspected allergy to test drug components;
Researchers believe that participants are not suitable for this experiment for other reasons.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Henan Cancer Hospital
Zhengzhou, Henan

Other trials in China

About this study

Official title: A Single-arm, Open, Dose-increasing Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetics of BAT1006 in Patients with Her2-positive Advanced Solid Tumors

Secondary objectives: 1) To evaluate the pharmacokinetic characteristics of BAT1006 after single and multiple dosing; 2) To study the immunogenicity of BAT1006; 3) Preliminary evaluation of anti-tumor efficacy of BAT1006.

Read the detailed description

This trial is an open phase I, dose-escalation clinical study. The first administration period was the 21st day, namely the DLT observation period. DLT observation was conducted to explore the safety, tolerability, pharmacokinetics and immunogenicity of MTD, single administration. After the observation period of DLT, the drug was administered once every 3 weeks, and the tolerance, pharmacokinetics, immunogenicity and preliminary effectiveness of multiple administration were evaluated. If some dose groups show better efficacy, the investigator and the sponsor may select 1-2 dose groups that have been found to have efficacy after negotiation and discussion for extended study to further explore the safety and efficacy of the drug.

Conditions: Advanced Solid Tumor
Being tested: BAT1006

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BAT1006Drug
Also called Recombinant humanized anti-HER2 monoclonal antibody for injection
Intravenous fluids

Study groups in NCT05414136
Study group	Role	What they receive
A1/3mg/kg	Experimental	Dose: 3mg/kg Receives: Drug: BAT1006
A2/6mg/kg	Experimental	Dose: 6mg/kg Receives: Drug: BAT1006
A3/10mg/kg	Experimental	Dose: 10mg/kg Receives: Drug: BAT1006
A4/15mg/kg	Experimental	Dose: 15mg/kg Receives: Drug: BAT1006
A5/20mg/kg	Experimental	Dose: 20mg/kg Receives: Drug: BAT1006

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose limiting toxicity (DLT)
Dose-limiting toxicity (DLT) is defined as any of the following adverse events (CTCAE Version 5.0 classification for the evaluation of adverse effects) that occur during the first treatment cycle that are definitely or possibly related to the investigatory drug:
1. Grade ≥3 non-hematological toxicity (nausea, vomiting and diarrhea can be relieved within 3 days after supportive treatment, except for infusion reactions that can be recovered within 2 hours after symptomatic treatment);
2. Hematological toxicity 2.1 Grade ≥3 neutropenia with fever, or grade 3 thrombocytopenia with significant bleeding; 2.2 Grade ≥4 hematologic toxicity: thrombocytopenia for more than 5 days, or grade 4 neutropenia for more than 7 days;
3. LVEF decreased by > 15% or LVEF value decreased by < 50% from baseline;
4. In the case of other SAE or AE that the researcher considers unacceptable, the researcher will communicate with the sponsor to decide whether to judge it as DLT.
Measured: 21 days
Maximum tolerance dose（MTD）
MTD is defined as the highest dose level of DLT observed in ≤1/6 subjects in a dose group during the DLT evaluation period
Measured: 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Feb 202217 Jun 2024

First posted10 Jun 2022
Study start10 Feb 2022
Primary completion17 Jun 2024
Study completion17 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced 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
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05414136
Sponsor's protocol ID: BAT-1006-001-CR
Status last verified: Dec 2024
First submitted: 8 Jun 2022
Last updated: 24 Dec 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
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

All Advanced Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-arm, Open, Dose-increasing Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetics of BAT1006 in Patients with Her2-positive Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05414136
Acronym / sponsor ID: BAT-1006-001-CR
Conditions: Advanced Solid Tumor
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Bio-Thera SolutionsIndustry (pharma, biotech, devices)
Study start: 10 Feb 2022 (actual)
Primary completion: 17 Jun 2024 (actual)
Study completion: 17 Jun 2024 (actual)
First posted: 10 Jun 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
A1/3mg/kg	Experimental	Drug: BAT1006Dose: 3mg/kg
A2/6mg/kg	Experimental	Drug: BAT1006Dose: 6mg/kg
A3/10mg/kg	Experimental	Drug: BAT1006Dose: 10mg/kg
A4/15mg/kg	Experimental	Drug: BAT1006Dose: 15mg/kg
A5/20mg/kg	Experimental	Drug: BAT1006Dose: 20mg/kg

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

The patient or his legal representative signs the informed consent, fully understands the content, process and possible adverse reactions of the trial, and is willing to conduct follow-up and imaging evaluation in accordance with the time specified in the trial;
Age 18-80 years old (including boundary value), gender is not limited;
Patients with locally advanced or metastatic solid tumors confirmed by histopathology and/or cytology as HER2-positive. The extended study was limited to patients with HER2-positive locally advanced or metastatic breast and stomach cancer. Her2-positive (HER2-positive defined as IHC3+ or FISH+);
Patients with no effective treatment or failure of standard treatment;
Tumor with at least one measurable lesion according to Recist version 1.1 criteria;

Key exclusion criteria (18 listed)

Previous doxorubicin cumulative dose \> Subjects with 360 mg/m2 or equivalent anthracyclines;
Previous treatment with trastuzumab, pertuzumab, or other HER2-targeted drugs (including but not limited to grade 3 or higher infusion reactions or allergic reactions, LVEF < 50% after treatment, or grade 3 or higher diarrhea);
The toxic effects of previous antitumor therapy have not returned to grade 0 to 1 as defined in CTCAE version 5.0, except for alopecia, pigmentation and anemia;
Patients who have received other anti-tumor therapy, such as chemotherapy, radiotherapy (but for palliative radiotherapy within 2 weeks before the first dose), biological products, etc., within 4 weeks of the first dose (targeted therapy/immunotherapy with a minimum interval of 4 weeks or at least 5 half-lives, whichever is shorter; Within 6 weeks before administration of nitrosourea and mitomycin C, within 2 weeks before administration of oral fluorouracil, within 1 week before administration of NMPA-approved Chinese patent medicine or treatment clearly with anti-tumor related functions, or Chinese herbal therapy clearly recorded in the medical records for anti-tumor purposes);
The presence of ≥2 grade peripheral neuropathy (CTCAE5.0 grade);

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
BAT1006Also: Recombinant humanized anti-HER2 monoclonal antibody for injectionIntravenous fluids	Drug	A1/3mg/kg, A2/6mg/kg, A3/10mg/kg, A4/15mg/kg, A5/20mg/kg

Primary outcome

Dose limiting toxicity (DLT)
Time frame: 21 days
Dose-limiting toxicity (DLT) is defined as any of the following adverse events (CTCAE Version 5.0 classification for the evaluation of adverse effects) that occur during the first treatment cycle that are definitely or possibly related to the investigatory drug: 1. Grade ≥3 non-hematological toxicity (nausea, vomiting and diarrhea can be relieved within 3 days after supportive treatment, except for infusion reactions that can be recovered within 2 hours after symptomatic treatment); 2. Hematological toxicity 2.1 Grade ≥3 neutropenia with fever, or grade 3 thrombocytopenia with significant bleeding; 2.2 Grade ≥4 hematologic toxicity: thrombocytopenia for more than 5 days, or grade 4 neutropenia for more than 7 days; 3. LVEF decreased by > 15% or LVEF value decreased by < 50% from baseline; 4. In the case of other SAE or AE that the researcher considers unacceptable, the researcher will communicate with the sponsor to decide whether to judge it as DLT.
Maximum tolerance dose（MTD）
Time frame: 21 days
MTD is defined as the highest dose level of DLT observed in ≤1/6 subjects in a dose group during the DLT evaluation period

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
Individual participant dataSharing planned: No

Related trials for Advanced Solid Tumor

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
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.

Shusen Wang principal investigator

Sun Yat-Sen University Cancer Center

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 BAT1006 in people with Advanced Solid Tumor, 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 10 inclusion and 18 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: finished, as of the sponsor's last update on 24 Dec 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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: 21 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?

On the ClinicalTrials.gov record for NCT05414136.

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 24 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.