Clinical trial NCT05200013: BAT7104 in Patients With Advanced Solid Tumours
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Patients With Advanced Solid Tumors
Lead sponsor: Bio-Thera Solutions
Sponsor class: INDUSTRY
Collaborators: name: George Clinical Pty Ltd
First posted: 2022-01-20
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Dose-limiting toxicity (DLT)
timeFrame: A minimum of 28 days after first dose of BAT-7104
measure: Adverse Events (AEs)
timeFrame: up to 90 days after the last dose, an average of 1 year
measure: Serious adverse events (SAEs)
timeFrame: From the time of informed consent to 90 days after the last dose, an average of 1 year
Secondary outcomes:
measure: Cmax (Maximum serum concentration)
timeFrame: up to Cycle 6, each cycle is 14 days
measure: Presence of anti-drug antibodies (ADAs) / neutralizing antibodies (NAbs)
timeFrame: up to Cycle 6, each cycle is 14 days
measure: Objective response rate (ORR)
timeFrame: 12 months (anticipated)
measure: Tmax (Time to reach maximum serum concentration)
timeFrame: up to Cycle 6, each cycle is 14 days
measure: AUC0-inf after Cycle 1 administration and AUC0- λ after Cycle 6 administration
timeFrame: up to Cycle 6, each cycle is 14 days
measure: Systemic Clearance (CL)
timeFrame: up to Cycle 6, each cycle is 14 days
measure: Vss (volume of distribution at steady state)
timeFrame: up to Cycle 6, each cycle is 14 days
measure: t1/2 (terminal half-life)
timeFrame: up to Cycle 6, each cycle is 14 days
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Macquarie University
state: New South Wales
city: Nedlands
country: Australia
facility: One Clinical Research Pty Ltd
Study officials:
References: