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

Bio-Thera Solutions

Status and phase: Terminated; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: BAT6021; Drug: BAT1308

Study type: Interventional

Funder types: Industry

Identifiers

NCT05073484

BAT-6021-002-CR

Details and patient eligibility

About

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.

Full description

Anti-PD-1 and anti-PD-L1 antibodies targeting the immuno-inhibitory PD-1 pathway (thus activating T cells) have achieved clinical success in many types of cancers. However, studies have shown that anti-TIGIT antibodies not only trigger T cells and Natural Killer(NK) cells, but they can also activate T cells to a greater extent than anti-PD-1 antibodies. Therefore, further clinical investigation of anti-TIGIT antibodies such as BAT6021 is warranted.

PD-1 and TIGIT are commonly co-expressed in T cells of the same tumor; thus, combining anti-TIGIT antibodies with PD-1/PD-L1 inhibitors may be a more effective cancer treatment. Indeed, anti-TIGIT antibodies have demonstrated synergy with anti-PD-1/PD-L1 antibodies in preclinical models. In addition, sponsor have shown that single administration of BAT1308 or BAT6021 could not effectively inhibit CT26 tumor growth in PD-1/TIGIT- humanized syngeneic mice; however, the combination treatment resulted in potent anti-tumor activity. Therefore, combined treatment with BAT6021 and an anti-PD-1/PD-L1 antibody like BAT1308 could improve therapeutic outcomes.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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13 participants in 9 patient groups

10 mg of BAT6021

Experimental group

Description:

BAT6021 100mg/vial，10mg Ⅳ infusions

Treatment:

Drug: BAT6021

30 mg of BAT6021

Experimental group

Description:

BAT6021 100mg/vial，30mg Ⅳ infusions

Treatment:

Drug: BAT6021

100 mg of BAT6021

Experimental group

Description:

BAT6021 100mg/vial，100mg Ⅳ infusions

Treatment:

Drug: BAT6021

300 mg of BAT6021

Experimental group

Description:

BAT6021 100mg/vial，300mg Ⅳ infusions

Treatment:

Drug: BAT6021

600 mg of BAT6021

Experimental group

Description:

BAT6021 100mg/vial，600mg Ⅳ infusions

Treatment:

Drug: BAT6021

900 mg of BAT6021

Experimental group

Description:

BAT6021 100mg/vial，900mg Ⅳ infusions

Treatment:

Drug: BAT6021

100mg BAT6021+300mg BAT1308

Experimental group

Description:

BAT6021 100mg/vial，BAT1308 100mg/vial ; BAT6021 100mg+BAT1308 300mg Ⅳ infusions

Treatment:

Drug: BAT1308

Drug: BAT6021

300mg BAT6021+300mg BAT1308

Experimental group

Description:

BAT6021 100mg/vial，BAT1308 100mg/vial ; BAT6021 300mg+BAT1308 300mg Ⅳ infusions

Treatment:

Drug: BAT1308

Drug: BAT6021

600mg BAT6021+300mg BAT1308

Experimental group

Description:

BAT6021 100mg/vial，BAT1308 100mg/vial ; BAT6021 600mg+BAT1308 300mg Ⅳ infusions

Treatment:

Drug: BAT1308

Drug: BAT6021