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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05200013




Registration number
NCT05200013
Ethics application status
Date submitted
25/11/2021
Date registered
20/01/2022
Date last updated
18/04/2024

Titles & IDs
Public title
BAT7104 in Patients With Advanced Solid Tumours
Scientific 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
Secondary ID [1] 0 0
BAT-7104-002-CR
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients With Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - BAT7104

Experimental: Cohort 1 - Dose 0.3mg/kg

Experimental: Cohort 2 - Dose 1mg/kg

Experimental: Cohort 3 - Dose: 3 mg/kg

Experimental: Cohort 4 - Dose: 10 mg/kg

Experimental: Cohort 5 - Dose: 20 mg/kg

Experimental: Cohort 6 - Dose: 40 mg/kg


Other interventions: BAT7104
Symmetric IgG-like AntiPD-L1/CD47 Bispecific Antibody Solution for Injection BAT7104 injection available in 100 mg/2 mL (50 mg/mL) dosage
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose-limiting toxicity (DLT)
Timepoint [1] 0 0
A minimum of 28 days after first dose of BAT-7104
Primary outcome [2] 0 0
Adverse Events (AEs)
Timepoint [2] 0 0
up to 90 days after the last dose, an average of 1 year
Primary outcome [3] 0 0
Serious adverse events (SAEs)
Timepoint [3] 0 0
From the time of informed consent to 90 days after the last dose, an average of 1 year
Secondary outcome [1] 0 0
Cmax (Maximum serum concentration)
Timepoint [1] 0 0
up to Cycle 6, each cycle is 14 days
Secondary outcome [2] 0 0
Presence of anti-drug antibodies (ADAs) / neutralizing antibodies (NAbs)
Timepoint [2] 0 0
up to Cycle 6, each cycle is 14 days
Secondary outcome [3] 0 0
Objective response rate (ORR)
Timepoint [3] 0 0
12 months (anticipated)
Secondary outcome [4] 0 0
Tmax (Time to reach maximum serum concentration)
Timepoint [4] 0 0
up to Cycle 6, each cycle is 14 days
Secondary outcome [5] 0 0
AUC0-inf after Cycle 1 administration and AUC0- ? after Cycle 6 administration
Timepoint [5] 0 0
up to Cycle 6, each cycle is 14 days
Secondary outcome [6] 0 0
Systemic Clearance (CL)
Timepoint [6] 0 0
up to Cycle 6, each cycle is 14 days
Secondary outcome [7] 0 0
Vss (volume of distribution at steady state)
Timepoint [7] 0 0
up to Cycle 6, each cycle is 14 days
Secondary outcome [8] 0 0
t1/2 (terminal half-life)
Timepoint [8] 0 0
up to Cycle 6, each cycle is 14 days

Eligibility
Key inclusion criteria
1. Able to give voluntary informed consent and understand the study and are willing to
follow and complete all the study required procedures.

2. Aged = 18 years

3. Life expectancy = 3 months.

4. Eastern Cooperative Oncology Group (ECOG)performance status = 1.

5. 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.

6. 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.

7. Adequate haematological, liver, and kidney function

8. International normalized ratio (INR) /prothrombin time (PT)< 2, activated partial
thromboplastin time (aPTT) = 1.5 × upper limits of normal (ULN).

9. 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Females who are pregnant or nursing;

2. Receiving concurrent anticancer therapy or investigational therapy (including
chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, targeted
therapy, biologic therapy);

3. 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).

4. 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.

5. 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.

6. History of tissue or organ transplantation.

7. 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.

8. History of human immunodeficiency virus (HIV) infection or history of autoimmune
diseases.

9. Active hepatitis B or C.

10. History of a Grade 3 or Grade 4 allergic reaction to treatment with another monoclonal
antibody.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
29
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Macquarie University - Sydney
Recruitment hospital [2] 0 0
One Clinical Research Pty Ltd - Nedlands
Recruitment postcode(s) [1] 0 0
2109 - Sydney
Recruitment postcode(s) [2] 0 0
- Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bio-Thera Solutions
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
George Clinical Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05200013
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries