- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05200013
BAT7104 in Patients With Advanced Solid Tumours
April 17, 2024 updated by: Bio-Thera Solutions
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
29
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lesley Liu
- Phone Number: +86-20-32203220
- Email: yrliu@bio-thera.com
Study Contact Backup
- Name: Zhaohe Wang
- Email: zhwang@bio-thera.com
Study Locations
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-
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Nedlands, Australia
- One Clinical Research PTY LTD
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New South Wales
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Sydney, New South Wales, Australia, 2109
- Macquarie University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
Dose 0.3mg/kg
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Symmetric IgG-like AntiPD-L1/CD47 Bispecific Antibody Solution for Injection BAT7104 injection available in 100 mg/2 mL (50 mg/mL) dosage
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Experimental: Cohort 2
Dose 1mg/kg
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Symmetric IgG-like AntiPD-L1/CD47 Bispecific Antibody Solution for Injection BAT7104 injection available in 100 mg/2 mL (50 mg/mL) dosage
|
Experimental: Cohort 3
Dose: 3 mg/kg
|
Symmetric IgG-like AntiPD-L1/CD47 Bispecific Antibody Solution for Injection BAT7104 injection available in 100 mg/2 mL (50 mg/mL) dosage
|
Experimental: Cohort 4
Dose: 10 mg/kg
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Symmetric IgG-like AntiPD-L1/CD47 Bispecific Antibody Solution for Injection BAT7104 injection available in 100 mg/2 mL (50 mg/mL) dosage
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Experimental: Cohort 5
Dose: 20 mg/kg
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Symmetric IgG-like AntiPD-L1/CD47 Bispecific Antibody Solution for Injection BAT7104 injection available in 100 mg/2 mL (50 mg/mL) dosage
|
Experimental: Cohort 6
Dose: 40 mg/kg
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Symmetric IgG-like AntiPD-L1/CD47 Bispecific Antibody Solution for Injection BAT7104 injection available in 100 mg/2 mL (50 mg/mL) dosage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose-limiting toxicity (DLT)
Time Frame: A minimum of 28 days after first dose of BAT-7104
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Number of subjects who experience DLT events during 28 days.
Toxicity will be graded according to CTCAE, Version 5.0.
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A minimum of 28 days after first dose of BAT-7104
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Adverse Events (AEs)
Time Frame: up to 90 days after the last dose, an average of 1 year
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Incidence of treatment -related AEs as assessed by CTCAE, Version 5.0.
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up to 90 days after the last dose, an average of 1 year
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Serious adverse events (SAEs)
Time Frame: From the time of informed consent to 90 days after the last dose, an average of 1 year
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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.
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From the time of informed consent to 90 days after the last dose, an average of 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR)
Time Frame: 12 months (anticipated)
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The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
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12 months (anticipated)
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Cmax (Maximum serum concentration)
Time Frame: up to Cycle 6, each cycle is 14 days
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Maximum observed plasma or serum concentration
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up to Cycle 6, each cycle is 14 days
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Presence of anti-drug antibodies (ADAs) / neutralizing antibodies (NAbs)
Time Frame: up to Cycle 6, each cycle is 14 days
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up to Cycle 6, each cycle is 14 days
|
|
Tmax (Time to reach maximum serum concentration)
Time Frame: up to Cycle 6, each cycle is 14 days
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Time to Maximum concentration
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up to Cycle 6, each cycle is 14 days
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AUC0-inf after Cycle 1 administration and AUC0- λ after Cycle 6 administration
Time Frame: up to Cycle 6, each cycle is 14 days
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area under the serum concentration versus time curve from time zero to infinity and to time λ
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up to Cycle 6, each cycle is 14 days
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Systemic Clearance (CL)
Time Frame: up to Cycle 6, each cycle is 14 days
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Systemic dose clearance
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up to Cycle 6, each cycle is 14 days
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Vss (volume of distribution at steady state)
Time Frame: up to Cycle 6, each cycle is 14 days
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Amount of drug in the body divided by plasma concentration
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up to Cycle 6, each cycle is 14 days
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t1/2 (terminal half-life)
Time Frame: up to Cycle 6, each cycle is 14 days
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Apparent terminal-phase disposition half-life.
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up to Cycle 6, each cycle is 14 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 29, 2022
Primary Completion (Estimated)
September 30, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
November 25, 2021
First Submitted That Met QC Criteria
January 6, 2022
First Posted (Actual)
January 20, 2022
Study Record Updates
Last Update Posted (Actual)
April 18, 2024
Last Update Submitted That Met QC Criteria
April 17, 2024
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BAT-7104-002-CR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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