Assessment of Safety and Preliminary Efficacy With BAT6021 in Solid Tumor Patients

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

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.

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.