Locally Advanced/Metastatic Solid TumoursPhase 1NCT05405621
Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT8009
A Phase 1 study testing BAT8009 for Injection in people with Locally Advanced/Metastatic Solid Tumours, run by Bio-Thera Solutions at 1 site in China.
Trial summary
Primary objectives: To evaluate the safety and tolerability of BAT8009 in patients with advanced solid tumours. To determine the maximum tolerated dose (MTD) and recommended dose for Phase 2 (RP2D). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced/Metastatic Solid Tumours
- What is being tested?
- BAT8009 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2022to Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to give voluntary informed consent and understand the study and are willing to follow and complete all the study required procedures.
- Aged ≥ 18 years and ≤ 75 years.
- Life expectancy ≥ 3 months.
- ECOG performance status ≤ 1.
- Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumours that are refractory to standard therapy.
- Has measurable or evaluable disease per RECIST v1.1.
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- Adequate haematological, liver, kidney, cardiac and coagulation function.
- Is willing to provide pre-existing diagnostic or resected tumour samples (if available).
- Female patients must: Be of non-child-bearing potential; Male patients must: be willing not to donate sperm.
- Must agree to adhere to the current state and national advice regarding minimising exposure to COVID-19 from the first Screening visit until the end of study (28-day Safety Follow-up Visit).
Who cannot join
- Females who are pregnant or nursing.
- Receiving concurrent anticancer therapy or investigational therapy.
- Persisting AEs that are > Grade 1 from prior antitumour treatment as per CTCAE v5.0.
- Patients with primacy central nervous system (CNS) malignancy, symptomatic CNS metastases, meningeal metastases or leptomeningeal disease are not allowed.
- Had major surgery within 28 days of the Screening visit.
- History of autologous transplantation ≤ 3 months.
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- History of severe infection deemed clinically significant by the PI or designee within 4 weeks.
- History of human immunodeficiency virus (HIV) infection.
- Active hepatitis B or C.
- History of a Grade 3 or Grade 4 allergic reaction to treatment with other antibodies.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Li Zhang
About this study
Official title: A Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT8009 in Patients With Advanced Solid Tumours
Primary objectives:
- To evaluate the safety and tolerability of BAT8009 in patients with advanced solid tumours.
- To determine the maximum tolerated dose (MTD) and recommended dose for Phase 2 (RP2D).
Read the detailed description
This is a first-in-human (FIH), multicentre, open-label, Phase 1 dose escalation and dose expansion study of BAT8009 (a B7H3-targeting antibody-drug conjugate) in patients with advanced solid tumours.
- Being tested
- BAT8009 for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAT8009 for InjectionDrug
Also called Recombinant Humanized Anti-B7H3 Monoclonal Antibody-Exatecan Conjugate
BAT8009 will be administered as a 90-minute (± 5min) IV infusion on Day 1 of Cycle 1. If there is no infusion related reaction after initial dose, the next dose of BAT8009 will be infused intravenously into each patient for approximately 30~120 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Experimental: BAT8009 for Injection 0.6 mg/kg (frequency: Q3W) Receives: Drug: BAT8009 for Injection |
| Cohort 2 | Experimental | Drug: BAT8009 for Injection 1.2 mg/kg (frequency: Q3W) Receives: Drug: BAT8009 for Injection |
| Cohort 3 | Experimental | Drug: BAT8009 for Injection 2.4 mg/kg (frequency: Q3W) Receives: Drug: BAT8009 for Injection |
| Cohort 4 | Experimental | Drug: BAT8009 for Injection 3.6mg/kg (frequency: Q3W) Receives: Drug: BAT8009 for Injection |
| Cohort 5 | Experimental | Drug: BAT8009 for Injection 4.8mg/kg (frequency: Q3W) Receives: Drug: BAT8009 for Injection |
| Cohort6 | Experimental | Drug: BAT8009 for Injection 6.0mg/kg (frequency: Q3W) Receives: Drug: BAT8009 for Injection |
| Cohort 7 | Experimental | Drug: BAT8009 for Injection 7.2mg/kg (frequency: Q3W) Receives: Drug: BAT8009 for Injection |
| Cohort 8 | Experimental | Drug: BAT8009 for Injection 8.4mg/kg (frequency: Q3W) Receives: Drug: BAT8009 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity(DLT)
A DLT is defined as a toxicity occurring during the DLT observation period
Measured: A minimum of 21 days after first dose of BAT8009
Secondary outcomes (3)
Cmax (Maximum serum concentration)
Maximum observed plasma or serum concentration
Measured: 126 days after first dosing
Immunogenicity
Presence of ADAs / neutralizing antibodies (NAbs).
Measured: 126 days after first dosing
AUC0-inf after Cycle 1 administration and AUC0- λ after Cycle 6 administration
area under the serum concentration versus time curve from time zero to infinity and to time λ
Measured: 126 days after first dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start2 Aug 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced/Metastatic Solid TumoursStudies 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bio-Thera Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Zhang, M.D, Ph.D, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405621
- Sponsor's protocol ID
- BAT-8009-001-CR
- Status last verified
- Oct 2022
- First submitted
- 30 May 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT8009 in Patients With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT05405621
- Acronym / sponsor ID
- BAT-8009-001-CR
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Bio-Thera SolutionsIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 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.
Primary objectives:
- To evaluate the safety and tolerability of BAT8009 in patients with advanced solid tumours.
- To determine the maximum tolerated dose (MTD) and recommended dose for Phase 2 (RP2D).
Detailed description
This is a first-in-human (FIH), multicentre, open-label, Phase 1 dose escalation and dose expansion study of BAT8009 (a B7H3-targeting antibody-drug conjugate) in patients with advanced solid tumours.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: BAT8009 for InjectionExperimental: BAT8009 for Injection 0.6 mg/kg (frequency: Q3W) |
| Cohort 2 | Experimental | Drug: BAT8009 for InjectionDrug: BAT8009 for Injection 1.2 mg/kg (frequency: Q3W) |
| Cohort 3 | Experimental | Drug: BAT8009 for InjectionDrug: BAT8009 for Injection 2.4 mg/kg (frequency: Q3W) |
| Cohort 4 | Experimental | Drug: BAT8009 for InjectionDrug: BAT8009 for Injection 3.6mg/kg (frequency: Q3W) |
| Cohort 5 | Experimental | Drug: BAT8009 for InjectionDrug: BAT8009 for Injection 4.8mg/kg (frequency: Q3W) |
| Cohort6 | Experimental | Drug: BAT8009 for InjectionDrug: BAT8009 for Injection 6.0mg/kg (frequency: Q3W) |
| Cohort 7 | Experimental | Drug: BAT8009 for InjectionDrug: BAT8009 for Injection 7.2mg/kg (frequency: Q3W) |
| Cohort 8 | Experimental | Drug: BAT8009 for InjectionDrug: BAT8009 for Injection 8.4mg/kg (frequency: Q3W) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able to give voluntary informed consent and understand the study and are willing to follow and complete all the study required procedures.
- Aged ≥ 18 years and ≤ 75 years.
- Life expectancy ≥ 3 months.
- ECOG performance status ≤ 1.
- Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumours that are refractory to standard therapy.
Key exclusion criteria (10 listed)
- Females who are pregnant or nursing.
- Receiving concurrent anticancer therapy or investigational therapy.
- Persisting AEs that are > Grade 1 from prior antitumour treatment as per CTCAE v5.0.
- Patients with primacy central nervous system (CNS) malignancy, symptomatic CNS metastases, meningeal metastases or leptomeningeal disease are not allowed.
- Had major surgery within 28 days of the Screening visit.
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 |
|---|---|---|
| BAT8009 for InjectionAlso: Recombinant Humanized Anti-B7H3 Monoclonal Antibody-Exatecan ConjugateBAT8009 will be administered as a 90-minute (± 5min) IV infusion on Day 1 of Cycle 1. If there is no infusion related reaction after initial dose, the next dose of BAT8009 will be infused intravenously into each patient for approximately 30~120 minutes. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 7, Cohort 8, Cohort6 |
Primary outcome
Dose-limiting toxicity(DLT)
Time frame: A minimum of 21 days after first dose of BAT8009
A DLT is defined as a toxicity occurring during the DLT observation period
3 secondary outcomes
Cmax (Maximum serum concentration)
Time frame: 126 days after first dosing
Immunogenicity
Time frame: 126 days after first dosing
AUC0-inf after Cycle 1 administration and AUC0- λ after Cycle 6 administration
Time frame: 126 days after first dosing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: No. no plan to share IPD
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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.
Li Zhang, M.D, Ph.D principal investigator
Sun Yat-sen University
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 BAT8009 for Injection in people with Locally Advanced/Metastatic Solid Tumours, 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 10 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 27 Oct 2022. 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?
Contact Cailing Gu (+86-20-22233606, clgu@bio-thera.com), or a site near the patient. 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 BAT8009). 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 27 Oct 2022.