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HER2-Positive Solid TumorsPhase 1NCT04189211

A Clinical Trial of BAT8001 on Safety, Tolerability and Pharmacokinetics for Patients

A Phase 1 study testing BAT8001 in people with HER2-Positive Solid Tumors, run by Bio-Thera Solutions at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

An Open-Label, Dose Escalation Phase I Clinical Trial on Safety, Tolerability and Pharmacokinetics of BAT8001 for Injection in Patients with HER2-Positive Solid Tumors (breast cancer or gastric cancer)。 Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
HER2-Positive Solid Tumors
What is being tested?
BAT8001
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
7 Mar 2017to 31 Dec 2020
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with advanced solid tumors refractory to standard treatment or of intolerable or no standard treatment.
  • Patients with breast cancer or gastric cancer (including gastroesophageal junction adenocarcinoma) histopathologically or cytologically diagnosed and tested HER2-positive (IHC 3+ and/or ISH+);
  • At least one measurable lesion according to RECIST version 1.1;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • Absence of severe hematopoietic abnormalities, and basically normal heart, lung, liver and kidney functions;
  • Expected survival ≥ 3 months;
  • Left ventricular ejection fraction (LVEF) by ultrasound examinations higher than the lower limit of normal range defined by the study site;
  • The cumulative dose of anthracyclines should meet the following: the cumulative dose must not exceed the equivalent dose of 360 mg/m2 doxorubicin.

Who cannot join

  • Have active hepatitis B virus or hepatitis C;
  • Patients who are positive for the human immunodeficiency virus;
  • Patients with a history of immunodeficiency, including HIV-positive or other acquired or congenital immunodeficiencies, or a history of organ transplantation;
  • Patients with clinically significant active infection as determined by the investigator;
  • Other concurrent, severe or uncontrollable systemic diseases (such as clinically significant metabolic disorders, poor wound healing, ulcers, etc.);
  • Moderate or severe dyspnea at rest caused by advanced malignant tumors or complications or serious primary lung diseases, or currently requiring continuous oxygen therapy, or currently having interstitial lung disease or pneumonia;
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  • Cardiac insufficiency within the past 6 months before enrollment based on the following definitions: Grade ≥ 3 symptomatic congestive heart failure (CHF) according to CTCAE v4.03, or a history of Grade ≥ 2 symptomatic congestive heart failure, transmural myocardial infarction, unstable angina according to New York Heart Association (NYHA) Functional Classification, or severe arrhythmia without proper medicinal control, severe heart block, uncontrolled hypertension, or clinically significant cardiovascular disease;
  • Patients with central nervous system or brain metastasis symptoms, or who have received treatment for central nervous system or brain metastasis within 3 month before the first dose;
  • Grade ≥ 2 peripheral neuropathy ;

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: An Open-Label, Dose Escalation Phase I Clinical Trial on Safety, Tolerability and Pharmacokinetics of BAT8001 for Injection in Patients With HER2-Positive Solid Tumors

An Open-Label, Dose Escalation Phase I Clinical Trial on Safety, Tolerability and Pharmacokinetics of BAT8001 for Injection in Patients with HER2-Positive Solid Tumors (breast cancer or gastric cancer)。

Read the detailed description

This is an open-label, dose escalation Phase I clinical study in two stages. Stage 1 consists of the first four cycles where the tolerability, safety, pharmacokinetics and immunogenicity of BAT8001 for injections will be studied and preliminary efficacy will be evaluated. Efficacy and safety assessments continue from the fifth cycle until disease progression or intolerable toxicities.

Being tested
BAT8001

What participants receive

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

  • BAT8001Drug

    Also called Recombinant Humanized Anti-HER2 Monoclonal Antibody-Maytansine Conjugate for Injection

    IV infusions.

Study groups in NCT04189211
Study groupRoleWhat they receive
1.2mg/kg of BAT8001ExperimentalBAT8001 100mg/box, 1.2mg/kg IV infusions
Receives: Drug: BAT8001
2.4mg/kg of BAT8001ExperimentalBAT8001 100mg/box, 2.4mg/kg IV infusions
Receives: Drug: BAT8001
3.6mg/kg of BAT8001ExperimentalBAT8001 100mg/box, 3.6mg/kg IV infusions
Receives: Drug: BAT8001
4.8mg/kg of BAT8001ExperimentalBAT8001 100mg/box, 4.8mg/kg IV infusions
Receives: Drug: BAT8001
6.0mg/kg of BAT8001ExperimentalBAT8001 100mg/box, 6.0mg/kg IV infusions
Receives: Drug: BAT8001

What is being measured

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

  1. Dose-limiting toxicity（DLT）

    DLT is defined as one of the following as per investigator related to study drug:

    1. Grade ≥ 3 non-hematologic, and non-liver organ toxicities (except for Grade 3 diarrhea, nausea and vomiting in the absence of prophylactics);
    2. Grade ≥ 3 cardiotoxicity, new segmental wall-motion abnormalities, or troponin I ≥ 0.2 ng/mL;
    3. Left ventricular ejection fraction (LVEF) ≤ 45% and a ≥ 10% decrease from baseline;
    4. Grade ≥ 4 thrombocytopenia or anemia;
    5. Grade ≥ 4 t neutropenia that persists for more than 4 days or accompanied by fever > 38.3 °C or persistent fever ≥ 38 °C for more than 1 hour;
    6. Grade ≥ 3 elevation in any one of total bilirubin (TBIL), aspartate transaminase (AST) or alanine transaminase (ALT).
    7. Serum transaminase > 3 × ULN and TBIL > 2 × ULN;
    8. For Grade 2 abnormalities in AST or ALT at baseline, a measurement ≥ 10 × ULN.

    Measured: A minimum of 21 days after first dose of BAT8001

  2. Maximum tolerated dosed (MTD)

    The highest dose level resulting in a DLT in ≤ 1 of 6 patients was declared the MTD.

    Measured: A minimum of 21 days after first dose of BAT8001

  3. Area under the curve (AUC)-BAT8001(antibody-drug conjugate), total antibody and Batansine (a maytansine derivative, which is the 3AA-MDC complex)

    AUC will be evaluated and reported for BAT8001 and its metabolites.

    Measured: pre-infusion (Hour 0), 30 minutes after end of BAT8001 infusion on Day 1 Cycle 1, 2, 3, 4 (each cycle is 21 days) up to approximately 3 months

  4. Maximum serum drug concentration (Cmax)-BAT8001(antibody-drug conjugate), total antibody and Batansine (a maytansine derivative, which is the 3AA-MDC complex)

    Maximum serum concentration (Cmax) immediately after dosing will be evaluated and reported for BAT8001 and its metabolites.

    Measured: pre-infusion (Hour 0), 30 minutes after end of BAT8001 infusion on Day 1 Cycle 1, 2, 3, 4 (each cycle is 21 days) up to approximately 3 months

  5. Half-life period(t1/2)

    Half-life (t1/2) will be evaluated and reported.

    Measured: pre-infusion (Hour 0), 30 minutes after end of BAT8001 infusion on Day 1 Cycle 1, 2, 3, 4 (each cycle is 21 days) up to approximately 3 months

  6. Anti drug antibodies (ADA)

    Plasma level of anti drug antibodies (ADA) correlated with BAT8001 plasma level

    Measured: pre-infusion (Hour 0) on Day 1 of Cycle 1, 2, 3, 4 (each cycle is 21 days) up to approximately 3 months

  7. Neutralizing anti-drug antibodies (NADA)

    Neutralizing anti-drug antibodies (NADA) correlated with BAT8001

    Measured: pre-infusion (Hour 0) on Day 1 of Cycle 1, 2, 3, 4 (each cycle is 21 days) up to approximately 3 months

Secondary outcomes (2)

  1. Progression free survival time(PFS)

    PFS is defined as the time from first dose date until the date of disease progression or death due to any reason, whichever occurs first.

    Measured: Baseline to the end of the study (up to 3 years)

  2. Overall response rate(ORR)

    determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

    Measured: Baseline to the end of the study (up to 3 years)

Timeline

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

  1. First posted6 Dec 2019
  2. Study start7 Mar 2017
  3. Primary completion31 Dec 2019 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04189211
Sponsor's protocol ID
BAT-8001-001-CR
Status last verified
Nov 2019
First submitted
26 Nov 2019
Last updated
6 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BAT8001 in people with HER2-Positive 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 8 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 6 Dec 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 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?

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: A minimum of 21 days after first dose of BAT8001). The study lists 7 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 NCT04189211.

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 6 Dec 2019.

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