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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/NCT05109650




Registration number
NCT05109650
Ethics application status
Date submitted
27/10/2021
Date registered
5/11/2021
Date last updated
1/05/2023

Titles & IDs
Public title
Assessment of Safety and Preliminary Efficacy With BAT6026 in Solid Tumour Patients
Scientific title
A Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT6026 as Monotherapy and in Combination With BAT1308 in Patients With Advanced Solid Tumours
Secondary ID [1] 0 0
BAT-6026-002-CR
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumour 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BAT6026
Treatment: Drugs - BAT1308

Experimental: 0.1mg/kg of BAT6026 + 300mg of BAT1308 - 0.1mg/kg of BAT6026 ? infusions at cycle 1(monotherapy), and 0.1mg/kg of BAT6026 IV infusions + 300mg of BAT1308 IV infusions(combination therapy) from cycle 2 until end of treatment

Experimental: 0.3mg/kg of BAT6026 + 300mg of BAT1308 - 0.3mg/kg of BAT6026 ? infusions at cycle 1(monotherapy), and 0.3mg/kg of BAT6026 IV infusions + 300mg of BAT1308 IV infusions(combination therapy) from cycle 2 until end of treatment

Experimental: 1mg/kg of BAT6026 + 300mg of BAT1308 - 1mg/kg of BAT6026 ? infusions at cycle 1(monotherapy), and 1mg/kg of BAT6026 IV infusions + 300mg of BAT1308 IV infusions(combination therapy) from cycle 2 until end of treatment

Experimental: 3mg/kg of BAT6026 + 300mg of BAT1308 - 3mg/kg of BAT6026 ? infusions at cycle 1(monotherapy), and 3mg/kg of BAT6026 IV infusions + 300mg of BAT1308 IV infusions(combination therapy) from cycle 2 until end of treatment

Experimental: 6mg/kg of BAT6026 + 300mg of BAT1308 - 6mg/kg of BAT6026 ? infusions at cycle 1(monotherapy), and 6mg/kg of BAT6026 IV infusions + 300mg of BAT1308 IV infusions(combination therapy) from cycle 2 until end of treatment

Experimental: 10mg/kg of BAT6026 + 300mg of BAT1308 - 10mg/kg of BAT6026 ? infusions at cycle 1(monotherapy), and 10mg/kg of BAT6026 IV infusions + 300mg of BAT1308 IV infusions(combination therapy) from cycle 2 until end of treatment


Treatment: Drugs: BAT6026
IV infusions

Treatment: Drugs: BAT1308
? infusions
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose-limiting toxicity(DLT)
Timepoint [1] 0 0
the first cycle of 21 days for monotherapy and the second cycle of another 21 days for combination therapy
Primary outcome [2] 0 0
Serious adverse event(SAE)
Timepoint [2] 0 0
Adverse events will be collected from the time of informed consent to 90 days after the last dose or until the initiation of a new cancer treatment.

Eligibility
Key inclusion criteria
- 1.Subjects able to give voluntary informed consent and understand the study and are
willing to follow and complete all the test procedures.

- 2. Male or female, age = 18 years.

- 3. Life expectancy =3 months.

- 4. ECOG performance status =1.

- 5. Histologically/cytologically confirmed, locally advanced unresectable or metastatic
solid tumours that are refractory to standard therapy, or for which no standard
therapy exists.

- 6. Has measurable disease per RECIST v1.1. that was not in a prior radiation or other
locally treated area, unless imaging-based progression has been clearly documented
following radiation or other local therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 1. Pregnant or nursing females.

- 2. Receiving concurrent anti-cancer therapy or investigational therapy (chemotherapy,
radiation therapy, surgery, immunotherapy, hormonal therapy, targeted therapy,
biologic therapy).

- 3. Any remaining AEs > Grade 1 from prior anti-tumour treatment as per CTCAE v5.0,
with exception of alopecia.

- 4 Subjects with primacy central nervous system (CNS) malignancy or symptomatic CNS
metastases are not allowed. Subjects with asymptomatic CNS metastases are eligible if
clinically controlled, which is defined as =4 weeks of stable neurologic function
following CNS-directed therapy, and no evidence of CNS disease progression as
determined by radiographic imaging = 4 weeks prior to the first dose of study drug.
Subjects who are receiving prednisone = 10mg or equivalent steroid therapies and have
a stable CNS symptom is allowed.

- 5. Subjects who have had major surgery within the 28-days from screening. If surgical
procedure occurs > 28 days, they must have recovered adequately from the toxicity
and/or complications from the intervention before the first dose of study drug.

- 6. Subjects with a history of tissue or organ transplantation.

- 7. Subjects who have had severe infection deemed clinically significant per
Investigator within 4 weeks or signs and symptoms of any active infection within 2
weeks prior to the first dose administration.

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

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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/03/2023
Sample size
Target
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St George Private Hospital - Kogarah
Recruitment hospital [2] 0 0
Blacktown Cancer and Haematology Centre - Sydney
Recruitment hospital [3] 0 0
Scientia Clinical Research Limited - Sydney
Recruitment postcode(s) [1] 0 0
- Kogarah
Recruitment postcode(s) [2] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bio-Thera Solutions
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a multicenter, open-label, Phase 1 dose-escalation study of BAT6026, an OX40
monoclonal antibody, combined with the anti-PD-1 IgG4 monoclonal antibody BAT1308 in subjects
with advanced solid tumours. After a screening period of up to 28 days, qualified subjects
will be enrolled to receive their assigned dose regimen until disease progression or
intolerable toxicity, withdrawal of consent, per Investigator decision, or end of study,
whichever occurs first. The maximum treatment duration is 1 year. Subjects who remain on
treatment in the absence of disease progression for more than 1 year may continue to receive
study drug for the next cycle at the maximum of 2 years.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05109650
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Prachi Bhave, M.D, Ph.D
Address 0 0
Scientia Clinical Research Ltd
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05109650