Assessment of Safety and Preliminary Efficacy With BAT6026 in Solid Tumour Patients

• Status: Not yet recruiting
• Trial end date: 2024-12-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bio-Thera Solutions
• Treatments: Antibodies; Immunoglobulins; Pharmaceutical Solutions

Criteria

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

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.