Patients With Advanced Solid TumorsPhase 1NCT05200013
BAT7104 in Patients With Advanced Solid Tumours
A Phase 1 study testing BAT7104 in people with Patients With Advanced Solid Tumors, run by Bio-Thera Solutions at 2 sites in Australia.
Trial summary
This is a prospective multi-centre, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT7104 in Patients with Advanced Solid Tumours in Australia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Advanced Solid Tumors
- What is being tested?
- BAT7104
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesAustralia
- Study dates
- 29 Apr 2022to 25 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 years and older
- 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
- Life expectancy ≥ 3 months.
- Eastern Cooperative Oncology Group （ECOG）performance status ≤ 1.
- Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumours that are refractory to standard therapy, or for whom no standard therapy exists, and where standard therapy is contraindicated or has been declined by the patient. Note that certain malignancies can be included based on imaging (e.g., HCC) and can be included based on the discretion of the PI, Sponsor Medical Monitor approval.
- Has measurable or evaluable disease per RECIST v1.1. that was not in a prior radiation or other locally treated area, unless imagingbased progression has been clearly documented following radiation or other local therapy.
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- Adequate haematological, liver, and kidney function
- International normalized ratio (INR) /prothrombin time (PT)< 2, activated partial thromboplastin time (aPTT) ≤ 1.5 × upper limits of normal （ULN）.
- 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 (90-day follow-up) visit.
Who cannot join
- Females who are pregnant or nursing;
- Receiving concurrent anticancer therapy or investigational therapy (including chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, targeted therapy, biologic therapy);
- Has remaining AEs > Grade 1 from prior antitumour treatment as per CTCAE v5.0, with the exception of alopecia or ≤ Grade 2 peripheral neuropathy. Patients with chronic Grade 2 toxicities may be eligible per discretion of the Investigator or designee and Sponsor Medical Monitor (e.g., Grade 2 chemotherapy induced neuropathy).
- Patients with primacy central nervous system (CNS) malignancy, symptomatic CNS metastases, meningeal metastases or leptomeningeal disease are not allowed. Note: Patients with asymptomatic CNS metastases are eligible if clinically controlled, which is defined as 1) ≥4 weeks of stable neurologic function following CNSdirected therapy prior to Cycle 1 Day 1 dosing, 2) no evidence of CNS disease progression as determined by radiographic imaging ≥ 4 weeks prior to Cycle 1 Day 1 dosing, 3) ≥ 2 weeks from discontinuation of anti-seizure and steroid therapies (receiving prednisone ≤ 10mg or equivalent steroid therapies is allowed) prior to Cycle 1 Day 1 dosing.
- Had major surgery within 28-days of the Screening visit. Note: Patients who have undergone a surgical procedure ≥ 28-days prior to Screening must have recovered adequately from the toxicity and/or complications from the intervention before the first dose of study drugs. Exception: no waiting period applies following port-a-cath placement for venous access.
- History of tissue or organ transplantation.
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- History of severe infection deemed clinically significant by the PI or designee within 4 weeks or signs and symptoms of any active infection within 2 weeks prior to the first dose of study drugs.
- History of human immunodeficiency virus (HIV) infection or history of autoimmune diseases.
- Active hepatitis B or C.
- History of a Grade 3 or Grade 4 allergic reaction to treatment with another monoclonal antibody.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
One Clinical Research Pty Ltd
Nedlands
Macquarie University
Sydney, New South Wales, 2109
About this study
Official title: A Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT7104 in Patients With Advanced Solid Tumours
This is a prospective multi-centre, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT7104 in Patients with Advanced Solid Tumours in Australia.
- Conditions
- Patients With Advanced Solid Tumors
- Being tested
- BAT7104
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAT7104Biological
Symmetric IgG-like AntiPD-L1/CD47 Bispecific Antibody Solution for Injection BAT7104 injection available in 100 mg/2 mL (50 mg/mL) dosage
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Dose 0.3mg/kg Receives: Biological: BAT7104 |
| Cohort 2 | Experimental | Dose 1mg/kg Receives: Biological: BAT7104 |
| Cohort 3 | Experimental | Dose: 3 mg/kg Receives: Biological: BAT7104 |
| Cohort 4 | Experimental | Dose: 10 mg/kg Receives: Biological: BAT7104 |
| Cohort 5 | Experimental | Dose: 20 mg/kg Receives: Biological: BAT7104 |
| Cohort 6 | Experimental | Dose: 40 mg/kg Receives: Biological: BAT7104 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Number of subjects who experience DLT events during 28 days. Toxicity will be graded according to CTCAE, Version 5.0.
Measured: A minimum of 28 days after first dose of BAT-7104
Adverse Events (AEs)
Incidence of treatment -related AEs as assessed by CTCAE, Version 5.0.
Measured: up to 90 days after the last dose, an average of 1 year
Serious adverse events (SAEs)
Any SAE that is judged by the PI or designee to be related to the study medication must be reported regardless of the amount of time since the last dose received. Follow-up information collected for any initial report of an SAE must also be reported to the Sponsor (or its designee) within 24 hours of receipt by the PI or designee.
Measured: From the time of informed consent to 90 days after the last dose, an average of 1 year
Secondary outcomes (8)
Cmax (Maximum serum concentration)
Maximum observed plasma or serum concentration
Measured: up to Cycle 6, each cycle is 14 days
Presence of anti-drug antibodies (ADAs) / neutralizing antibodies (NAbs)
Measured: up to Cycle 6, each cycle is 14 days
Objective response rate (ORR)
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
Measured: 12 months (anticipated)
Tmax (Time to reach maximum serum concentration)
Time to Maximum concentration
Measured: up to Cycle 6, each cycle is 14 days
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: up to Cycle 6, each cycle is 14 days
Systemic Clearance (CL)
Systemic dose clearance
Measured: up to Cycle 6, each cycle is 14 days
Vss (volume of distribution at steady state)
Amount of drug in the body divided by plasma concentration
Measured: up to Cycle 6, each cycle is 14 days
t1/2 (terminal half-life)
Apparent terminal-phase disposition half-life.
Measured: up to Cycle 6, each cycle is 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start29 Apr 2022
- Primary completion25 Jun 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Advanced Solid TumorsStudies 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Thera Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emerald Clinical Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200013
- Sponsor's protocol ID
- BAT-7104-002-CR
- Status last verified
- Oct 2023
- First submitted
- 25 Nov 2021
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. 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 BAT7104 in Patients With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT05200013
- Acronym / sponsor ID
- BAT-7104-002-CR
- Conditions
- Patients With Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Bio-Thera SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Emerald Clinical Inc.
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 20 Jan 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.
This is a prospective multi-centre, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT7104 in Patients with Advanced Solid Tumours in Australia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: BAT7104Dose 0.3mg/kg |
| Cohort 2 | Experimental | Biological: BAT7104Dose 1mg/kg |
| Cohort 3 | Experimental | Biological: BAT7104Dose: 3 mg/kg |
| Cohort 4 | Experimental | Biological: BAT7104Dose: 10 mg/kg |
| Cohort 5 | Experimental | Biological: BAT7104Dose: 20 mg/kg |
| Cohort 6 | Experimental | Biological: BAT7104Dose: 40 mg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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
- Life expectancy ≥ 3 months.
- Eastern Cooperative Oncology Group （ECOG）performance status ≤ 1.
- Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumours that are refractory to standard therapy, or for whom no standard therapy exists, and where standard therapy is contraindicated or has been declined by the patient. Note that certain malignancies can be included based on imaging (e.g., HCC) and can be included based on the discretion of the PI, Sponsor Medical Monitor approval.
Key exclusion criteria (10 listed)
- Females who are pregnant or nursing;
- Receiving concurrent anticancer therapy or investigational therapy (including chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, targeted therapy, biologic therapy);
- Has remaining AEs > Grade 1 from prior antitumour treatment as per CTCAE v5.0, with the exception of alopecia or ≤ Grade 2 peripheral neuropathy. Patients with chronic Grade 2 toxicities may be eligible per discretion of the Investigator or designee and Sponsor Medical Monitor (e.g., Grade 2 chemotherapy induced neuropathy).
- Patients with primacy central nervous system (CNS) malignancy, symptomatic CNS metastases, meningeal metastases or leptomeningeal disease are not allowed. Note: Patients with asymptomatic CNS metastases are eligible if clinically controlled, which is defined as 1) ≥4 weeks of stable neurologic function following CNSdirected therapy prior to Cycle 1 Day 1 dosing, 2) no evidence of CNS disease progression as determined by radiographic imaging ≥ 4 weeks prior to Cycle 1 Day 1 dosing, 3) ≥ 2 weeks from discontinuation of anti-seizure and steroid therapies (receiving prednisone ≤ 10mg or equivalent steroid therapies is allowed) prior to Cycle 1 Day 1 dosing.
- Had major surgery within 28-days of the Screening visit. Note: Patients who have undergone a surgical procedure ≥ 28-days prior to Screening must have recovered adequately from the toxicity and/or complications from the intervention before the first dose of study drugs. Exception: no waiting period applies following port-a-cath placement for venous access.
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 |
|---|---|---|
| BAT7104Symmetric IgG-like AntiPD-L1/CD47 Bispecific Antibody Solution for Injection BAT7104 injection available in 100 mg/2 mL (50 mg/mL) dosage | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: A minimum of 28 days after first dose of BAT-7104
Number of subjects who experience DLT events during 28 days. Toxicity will be graded according to CTCAE, Version 5.0.
Adverse Events (AEs)
Time frame: up to 90 days after the last dose, an average of 1 year
Incidence of treatment -related AEs as assessed by CTCAE, Version 5.0.
Serious adverse events (SAEs)
Time frame: From the time of informed consent to 90 days after the last dose, an average of 1 year
Any SAE that is judged by the PI or designee to be related to the study medication must be reported regardless of the amount of time since the last dose received. Follow-up information collected for any initial report of an SAE must also be reported to the Sponsor (or its designee) within 24 hours of receipt by the PI or designee.
8 secondary outcomes
Cmax (Maximum serum concentration)
Time frame: up to Cycle 6, each cycle is 14 days
Presence of anti-drug antibodies (ADAs) / neutralizing antibodies (NAbs)
Time frame: up to Cycle 6, each cycle is 14 days
Objective response rate (ORR)
Time frame: 12 months (anticipated)
Tmax (Time to reach maximum serum concentration)
Time frame: up to Cycle 6, each cycle is 14 days
AUC0-inf after Cycle 1 administration and AUC0- λ after Cycle 6 administration
Time frame: up to Cycle 6, each cycle is 14 days
Systemic Clearance (CL)
Time frame: up to Cycle 6, each cycle is 14 days
Vss (volume of distribution at steady state)
Time frame: up to Cycle 6, each cycle is 14 days
t1/2 (terminal half-life)
Time frame: up to Cycle 6, each cycle is 14 days
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 18 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 BAT7104 in people with Patients With Advanced Solid Tumors, run by Bio-Thera Solutions at 2 sites in Australia.
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 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: finished, as of the sponsor's last update on 18 Oct 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 Australia. 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: A minimum of 28 days after first dose of BAT-7104). The study lists 3 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 18 Oct 2024.