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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/NCT05073484




Registration number
NCT05073484
Ethics application status
Date submitted
9/09/2021
Date registered
11/10/2021
Date last updated
11/10/2023

Titles & IDs
Public title
Assessment of Safety and Preliminary Efficacy With BAT6021 in Solid Tumor Patients
Scientific title
A Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT6021 as Mono Therapy or in Combination With BAT1308 in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
BAT-6021-002-CR
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BAT6021
Treatment: Drugs - BAT1308

Experimental: 10 mg of BAT6021 - BAT6021 100mg/vial,10mg ? infusions

Experimental: 30 mg of BAT6021 - BAT6021 100mg/vial,30mg ? infusions

Experimental: 100 mg of BAT6021 - BAT6021 100mg/vial,100mg ? infusions

Experimental: 300 mg of BAT6021 - BAT6021 100mg/vial,300mg ? infusions

Experimental: 600 mg of BAT6021 - BAT6021 100mg/vial,600mg ? infusions

Experimental: 900 mg of BAT6021 - BAT6021 100mg/vial,900mg ? infusions

Experimental: 100mg BAT6021+300mg BAT1308 - BAT6021 100mg/vial,BAT1308 100mg/vial ; BAT6021 100mg+BAT1308 300mg ? infusions

Experimental: 300mg BAT6021+300mg BAT1308 - BAT6021 100mg/vial,BAT1308 100mg/vial ; BAT6021 300mg+BAT1308 300mg ? infusions

Experimental: 600mg BAT6021+300mg BAT1308 - BAT6021 100mg/vial,BAT1308 100mg/vial ; BAT6021 600mg+BAT1308 300mg ? infusions


Treatment: Drugs: BAT6021
? 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
A minimum of 21 days after first dose of BAT6021
Primary outcome [2] 0 0
Serious adverse event(SAE)
Timepoint [2] 0 0
From the time of informed consent to 90 days after the last dose or until the initiation of a new cancer treatment.
Secondary outcome [1] 0 0
Pharmacokinetics (PK)
Timepoint [1] 0 0
every cycle until cycle 6 (one cycle equals 3 weeks)
Secondary outcome [2] 0 0
Immunogenicity
Timepoint [2] 0 0
every cycle until cycle 6 (one cycle equals 3 weeks)

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

2. Aged = 18 years.

3. Life expectancy = 3 months.

4. ECOG performance status = 1.

5. Histologically/cytologically confirmed, locally advanced unresectable or metastatic
solid tumors that are refractory to standard therapy, or for whom 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. 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 antitumor treatment as per CTCAE v5.0, with the
exception of alopecia.

4. Participants with primacy central nervous system (CNS) malignancy, symptomatic CNS
metastases, meningeal metastases or leptomeningeal disease are not allowed. Note:
Participants with asymptomatic CNS metastases are eligible if clinically controlled,
which is defined as 1) = 4 weeks of stable neurologic function following CNS-directed
therapy prior to Screening, 2) no evidence of CNS disease progression as determined by
radiographic imaging = 4 weeks prior to Screening, 3) = 2 weeks from discontinuation
of anti-seizure and steroid therapies (receiving prednisone = 10mg or equivalent
steroid therapies is allowed) prior to Screening.

5. Had major surgery within 28-days of the Screening Visit. Note: Participants who have
undergone a non-major surgical procedure = 28 days prior to Screening must have
recovered adequately from the toxicity and/or complications from the intervention
before administration of the first dose of study drugs.

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. Note: Hepatitis B virus (HBV) carriers without active disease
(HBV DNA titer < 1000 copies/mL or 200 IU/mL) or cured Hepatitis C (negative HCV RNA
test) may be enrolled.

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
29/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/03/2023
Sample size
Target
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Macquarie University Hospital - Sydney
Recruitment hospital [3] 0 0
Cabrini Hospital Malvern - Melbourne
Recruitment postcode(s) [1] 0 0
- Liverpool
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
- Melbourne

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

Ethics approval
Ethics application status

Summary
Brief summary
This first-in-human open-label, multi center, dose-escalation and expansion study is designed
to evaluate the safety, tolerability, and PK of BAT6021 alone or in combination with BAT1308
(an anti-PD-1 antibody) in participants with locally advanced, recurrent, or metastatic
incurable tumors for whom standard therapy does not exist, has proven to be ineffective or
intolerable, or is considered inappropriate, or for whom a clinical trial of an
investigational agent is a recognized standard of care.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05073484
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Abhijit Pal, M.D, Ph.D
Address 0 0
Medical Oncologist at cancer Therapy, Liverpool Hospital
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/ct2/show/NCT05073484