Clinical Trials/NCT05200013

NCT05200013

Completed

Phase 1

A Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT7104 in Patients With Advanced Solid Tumours

Bio-Thera Solutions2 sites in 1 country14 target enrollmentApril 29, 2022

ConditionsPatients With Advanced Solid Tumors

InterventionsBAT7104

Overview

Phase: Phase 1
Intervention: BAT7104
Conditions: Patients With Advanced Solid Tumors
Sponsor: Bio-Thera Solutions
Enrollment: 14
Locations: 2
Primary Endpoint: Dose-limiting toxicity (DLT)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 29, 2022

End Date

June 25, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Bio-Thera Solutions

Responsible Party

Sponsor

Eligibility Criteria

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 ≤
•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.
•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.

Arms & Interventions

Cohort 1

Dose 0.3mg/kg

Intervention: BAT7104

Cohort 2

Dose 1mg/kg

Intervention: BAT7104

Cohort 3

Dose: 3 mg/kg

Intervention: BAT7104

Cohort 4

Dose: 10 mg/kg

Intervention: BAT7104

Cohort 5

Dose: 20 mg/kg

Intervention: BAT7104

Cohort 6

Dose: 40 mg/kg

Intervention: BAT7104

Outcomes

Primary Outcomes

Dose-limiting toxicity (DLT)

Time Frame: A minimum of 28 days after first dose of BAT-7104

Number of subjects who experience DLT events during 28 days. Toxicity will be graded according to CTCAE, Version 5.0.

Adverse Events (AEs)

Time Frame: up to 90 days after the last dose, an average of 1 year

Incidence of treatment -related AEs as assessed by CTCAE, Version 5.0.

Serious adverse events (SAEs)

Time Frame: From the time of informed consent to 90 days after the last dose, an average of 1 year

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.

Secondary Outcomes

Cmax (Maximum serum concentration)(up to Cycle 6, each cycle is 14 days)
Tmax (Time to reach maximum serum concentration)(up to Cycle 6, each cycle is 14 days)
Presence of anti-drug antibodies (ADAs) / neutralizing antibodies (NAbs)(up to Cycle 6, each cycle is 14 days)
Objective response rate (ORR)(12 months (anticipated))
AUC0-inf after Cycle 1 administration and AUC0- λ after Cycle 6 administration(up to Cycle 6, each cycle is 14 days)
Systemic Clearance (CL)(up to Cycle 6, each cycle is 14 days)
Vss (volume of distribution at steady state)(up to Cycle 6, each cycle is 14 days)
t1/2 (terminal half-life)(up to Cycle 6, each cycle is 14 days)