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

NCT05073484 | Terminated Phase 1

• 1 other identifier: BAT-6021-002-CR
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity(DLT)

  DLT is defined as one of the following as investigator related to study drug: Grade 5 toxicity; Hematologic Toxicity ; ≥ Grade 4 anemia; Grade 4 thrombocytopenia that lasts for ≥ 7 days or Grade 3 thrombocytopenia, if associated with clinically significant bleeding (≥ Grade 2 hemorrhage) or requires transfusion of platelets; Grade 4 neutropenia that lasts for ≥ 7 days, or Grade 3 neutropenia that lasts for ≥ 7 days or with documented infection; Grade 3 or Grade 4 febrile neutropenia of any duration.

  A minimum of 21 days after first dose of BAT6021

• Serious adverse event（SAE）

  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.

  From the time of informed consent to 90 days after the last dose or until the initiation of a new cancer treatment.

Secondary Outcomes (2)

• Pharmacokinetics (PK)

  every cycle until cycle 6 (one cycle equals 3 weeks)

• Immunogenicity

  every cycle until cycle 6 (one cycle equals 3 weeks)

Study Arms (9)

10 mg of BAT6021

EXPERIMENTAL

BAT6021 100mg/vial，10mg Ⅳ infusions

Drug: BAT6021

30 mg of BAT6021

EXPERIMENTAL

BAT6021 100mg/vial，30mg Ⅳ infusions

Drug: BAT6021

100 mg of BAT6021

EXPERIMENTAL

BAT6021 100mg/vial，100mg Ⅳ infusions

Drug: BAT6021

300 mg of BAT6021

EXPERIMENTAL

BAT6021 100mg/vial，300mg Ⅳ infusions

Drug: BAT6021

600 mg of BAT6021

EXPERIMENTAL

BAT6021 100mg/vial，600mg Ⅳ infusions

Drug: BAT6021

900 mg of BAT6021

EXPERIMENTAL

BAT6021 100mg/vial，900mg Ⅳ infusions

Drug: BAT6021

100mg BAT6021+300mg BAT1308

EXPERIMENTAL

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

Drug: BAT6021; Drug: BAT1308

300mg BAT6021+300mg BAT1308

EXPERIMENTAL

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

Drug: BAT6021; Drug: BAT1308

600mg BAT6021+300mg BAT1308

EXPERIMENTAL

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

Drug: BAT6021; Drug: BAT1308

Interventions

BAT6021 DRUG

Ⅳ infusions

Also known as: Recombinant Humanized Anti-TIGIT Antibody Solution for Injection

10 mg of BAT6021; 100 mg of BAT6021; 100mg BAT6021+300mg BAT1308; 30 mg of BAT6021; 300 mg of BAT6021; 300mg BAT6021+300mg BAT1308; 600 mg of BAT6021; 600mg BAT6021+300mg BAT1308; 900 mg of BAT6021

BAT1308 DRUG

Ⅳ infusions

Also known as: Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection

100mg BAT6021+300mg BAT1308; 300mg BAT6021+300mg BAT1308; 600mg BAT6021+300mg BAT1308

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures.
• Aged ≥ 18 years.
• Life expectancy ≥ 3 months.
• ECOG performance status ≤ 1.
• Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumors that are refractory to standard therapy, or for whom no standard therapy exists.
• 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.

You may not qualify if:

• 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 antitumor treatment as per CTCAE v5.0, with the exception of alopecia.
• 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.
• 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.
• 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. 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.

Sponsors & Collaborators

• Bio-Thera Solutions: lead

Study Sites (3)

Liverpool Hospital

Liverpool, New South Wales, Australia

Location

Macquarie University Hospital

Sydney, New South Wales, Australia

Location

Cabrini Hospital Malvern

Melbourne, Victoria, Australia

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Abhijit Pal, M.D, Ph.D

  Medical Oncologist at cancer Therapy, Liverpool Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: October 11, 2021
• Study Start: October 29, 2021
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)