Advanced Solid CancerPhase 1NCT03884517

Clinical Trial of BAT8003 (for Injection) for Patients With Advanced Epithelial Cancer

A Phase 1 study testing BAT8003 in people with Advanced Solid Cancer, run by Bio-Thera Solutions at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Advanced Solid Cancer
What is being tested?: BAT8003
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteChina
Study dates: 15 Mar 2019to 8 Feb 2021
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 75 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 form and fully understands the content, process of the study and possible adverse reactions of the study, and is willing to follow up and image evaluation according to the time specified in the protocol.
Age 18-75 years old (including boundary value), gender is not limited;
advanced epithelial cancer who are ineffective, unable to receive, or absent from standard treatment, histologically or cytologically confirmed;
positive Trop2 expression;
At least one measurable tumor lesions according to RECIST 1.1(Evaluation Standard for Solid Tumor Efficacy 1.1);
The US Eastern Cooperative Oncology Group (ECOG) scores 0 to 1;

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Expected survival period ≥ 3 months;
proper Laboratory test indicators:
Echocardiographic examination of left ventricular ejection fraction (LVEF) ≥ 50%;
The treatment for solid cancer has been completed for at least 3 weeks, and has basically recovered from the adverse reactions of previous treatment (≤1 grade according to CTCAE5.0（Common Terminology Criteria for Adverse Events 5.0） standard, except for hair loss);

Who cannot join

Have active hepatitis B (HBV) or hepatitis C (HCV) or syphilis;
History of immunodeficiency;
Other active infections of clinical significance, based on investigator's judgment;
other concurrent, severe, or uncontrollable systemic diseases ;
History of moderate or severe dyspnea due to advanced malignancy or its complications or severe pulmonary primary disease, or the need for continuous oxygen therapy, or current interstitial lung disease (ILD) Or pneumonia;
clinically significant Cardiovascular abnormalities according to any of the following definitions within 6 months prior to enrollment;

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The brain or other central nervous system metastasis symptom;;
There are ≥ 2 grade peripheral neuropathy according to CTCAE5.0（Common Terminology Criteria for Adverse Events 5.0）;
Participated in and received other clinical trials within 4 weeks prior to enrollment;
Major surgical treatment within 4 weeks;
Used of strong CYP3A4 inhibitors and have not undergone circulatory clearance (less than 3 elimination half-lives) prior to administration of the first clinical study drug;
Known allergy to the test drug component, or it is suspected that it may be allergic;
Pregnant or lactating women;
Alcohol abuse, drug abuse or history of drug abuse in the past 6 months;
The investigator believes the patient is not suitable for this trail because of other reasons.

Trial locations and contacts

1 site in 1 country.

China1 site

The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang

Other trials in China

About this study

Official title: An Open, Escalating Phase I Clinical Trial of BAT8003 (for Injection) on the Safety, Tolerability and Pharmacokinetics for Patients With Advanced Epithelial Cancer

The trial is divided into three periods. Dosing will be the first day of each cycle, 21 days per cycle. The first period is the day of first study drug delivery until the 21st day, that is, the first treatment cycle. The DLT observation, exploration of MTD, safety of single administration, tolerance and pharmacokinetics, immunity Original research will happen during this period. The second period is a 2-8 dosing cycle, with multiple doses of tolerance, pharmacokinetics, immunogenicity studies, and preliminary efficacy evaluations. After a 2-4 cycle study, patients with good tolerance and no tumor progression will continue to the 5-8 cycle dosing study. The third period is to expand the study. After exploring the MTD, the investigator and the sponsor can discuss to extend another 10-30 cases in a safe and effective dose group to further study the effectiveness and safety of BAT8003 and its pharmacokinetics.

Conditions: Advanced Solid Cancer
Being tested: BAT8003

What participants receive

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

BAT8003Drug
Phase 1 dose titration study from BAT8003 0.2mg/kg to 10mg/kg, then choose a proper dose for amplification study based on DLT result

Study groups in NCT03884517
Study group	Role	What they receive
BAT8003 0.2mg/kg	Experimental	BAT8003，0.2mg/kg，intravenous infusion, sample size 1-3 Receives: Drug: BAT8003
BAT8003 0.5mg/kg	Experimental	BAT8003，0.5mg/kg，intravenous infusion, sample size 1-3 Receives: Drug: BAT8003
BAT8003 1mg/kg	Experimental	BAT8003，1mg/kg，intravenous infusion, sample size 3 Receives: Drug: BAT8003
BAT8003 2mg/kg	Experimental	BAT8003，2mg/kg，intravenous infusion, sample size 3 Receives: Drug: BAT8003
BAT8003 4mg/kg	Experimental	BAT8003，4mg/kg，intravenous infusion, sample size 3 Receives: Drug: BAT8003
BAT8003 6mg/kg	Experimental	BAT8003，6mg/kg，intravenous infusion, sample size 3 Receives: Drug: BAT8003
BAT8003 8mg/kg	Experimental	BAT8003，8mg/kg，intravenous infusion, sample size 3 Receives: Drug: BAT8003
BAT8003 10mg/kg	Experimental	BAT8003，10mg/kg，intravenous infusion, sample size 3 Receives: Drug: BAT8003
Amplification group	Experimental	BAT8003，intravenous infusion，choose one proper dose from 0.2、0.5、1、2、4、6、8、10mg/kg Receives: Drug: BAT8003

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
maximum tolerated dose (MTD)
safety and tolerability endpoint
Measured: 3weeks
Area under the curve（AUC）
pharmacokinetic endpoint
Measured: no more than 24weeks
Maximum serum drug concentration（Cmax)
pharmacokinetic endpoint
Measured: no more than 24weeks
half-life period（t1/2）
pharmacokinetic endpoint
Measured: no more than 24weeks
Maximum serum drug time（Tmax）
pharmacokinetic endpoint
Measured: no more than 24weeks

Timeline

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

15 Mar 20198 Feb 2021

First posted21 Mar 2019
Study start15 Mar 2019
Primary completion8 Feb 2021
Study completion8 Feb 2021

Why it stopped: Considering that the safety risk will affect the subsequent development, it is decided to terminate the test voluntarily

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Solid CancerStudies 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: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03884517
Sponsor's protocol ID: BAT-8003-001-CR
Status last verified: Apr 2023
First submitted: 15 Mar 2019
Last updated: 1 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: 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 Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open, Escalating Phase I Clinical Trial of BAT8003 (for Injection) on the Safety, Tolerability and Pharmacokinetics for Patients With Advanced Epithelial Cancer
ClinicalTrials.gov ID: NCT03884517
Acronym / sponsor ID: BAT-8003-001-CR
Conditions: Advanced Solid Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Considering that the safety risk will affect the subsequent development, it is decided to terminate the test voluntarily
Enrolment: 5 participants (actual)
Lead sponsor: Bio-Thera SolutionsIndustry (pharma, biotech, devices)
Study start: 15 Mar 2019 (actual)
Primary completion: 8 Feb 2021 (actual)
Study completion: 8 Feb 2021 (actual)
First posted: 21 Mar 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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 9

Arm	Type	Receives
BAT8003 0.2mg/kg	Experimental	Drug: BAT8003BAT8003，0.2mg/kg，intravenous infusion, sample size 1-3
BAT8003 0.5mg/kg	Experimental	Drug: BAT8003BAT8003，0.5mg/kg，intravenous infusion, sample size 1-3
BAT8003 1mg/kg	Experimental	Drug: BAT8003BAT8003，1mg/kg，intravenous infusion, sample size 3
BAT8003 2mg/kg	Experimental	Drug: BAT8003BAT8003，2mg/kg，intravenous infusion, sample size 3
BAT8003 4mg/kg	Experimental	Drug: BAT8003BAT8003，4mg/kg，intravenous infusion, sample size 3
BAT8003 6mg/kg	Experimental	Drug: BAT8003BAT8003，6mg/kg，intravenous infusion, sample size 3
BAT8003 8mg/kg	Experimental	Drug: BAT8003BAT8003，8mg/kg，intravenous infusion, sample size 3
BAT8003 10mg/kg	Experimental	Drug: BAT8003BAT8003，10mg/kg，intravenous infusion, sample size 3
Amplification group	Experimental	Drug: BAT8003BAT8003，intravenous infusion，choose one proper dose from 0.2、0.5、1、2、4、6、8、10mg/kg

Who may qualify

Ages: 18 to 75 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 form and fully understands the content, process of the study and possible adverse reactions of the study, and is willing to follow up and image evaluation according to the time specified in the protocol.
Age 18-75 years old (including boundary value), gender is not limited;
advanced epithelial cancer who are ineffective, unable to receive, or absent from standard treatment, histologically or cytologically confirmed;
positive Trop2 expression;
At least one measurable tumor lesions according to RECIST 1.1(Evaluation Standard for Solid Tumor Efficacy 1.1);

Key exclusion criteria (15 listed)

Have active hepatitis B (HBV) or hepatitis C (HCV) or syphilis;
History of immunodeficiency;
Other active infections of clinical significance, based on investigator's judgment;
other concurrent, severe, or uncontrollable systemic diseases ;
History of moderate or severe dyspnea due to advanced malignancy or its complications or severe pulmonary primary disease, or the need for continuous oxygen therapy, or current interstitial lung disease (ILD) Or pneumonia;

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
BAT8003Phase 1 dose titration study from BAT8003 0.2mg/kg to 10mg/kg, then choose a proper dose for amplification study based on DLT result	Drug	Amplification group, BAT8003 0.2mg/kg, BAT8003 0.5mg/kg, BAT8003 10mg/kg, BAT8003 1mg/kg, BAT8003 2mg/kg, BAT8003 4mg/kg, BAT8003 6mg/kg, BAT8003 8mg/kg

Primary outcome

dose-limiting toxicity (DLT)
Time frame: 3weeks
safety and tolerability endpoint
maximum tolerated dose (MTD)
Time frame: 3weeks
safety and tolerability endpoint
Area under the curve（AUC）
Time frame: no more than 24weeks
pharmacokinetic endpoint
Maximum serum drug concentration（Cmax)
Time frame: no more than 24weeks
pharmacokinetic endpoint
half-life period（t1/2）
Time frame: no more than 24weeks
pharmacokinetic endpoint
Maximum serum drug time（Tmax）
Time frame: no more than 24weeks
pharmacokinetic endpoint

Results and safety

The study was stopped early (reason given: Considering that the safety risk will affect the subsequent development, it is decided to terminate the test voluntarily). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.

Related trials for Advanced Solid Cancer

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.

jian huang principal investigator

Second Affiliated Hospital, Zhejiang University, School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BAT8003 in people with Advanced Solid Cancer, 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 10 inclusion and 15 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: stopped early, as of the sponsor's last update on 1 May 2023. 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?

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?

On the ClinicalTrials.gov record for NCT03884517.

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 1 May 2023.