Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05073484
Other study ID # BAT-6021-002-CR
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date October 29, 2021
Est. completion date March 30, 2023

Study information

Verified date October 2023
Source Bio-Thera Solutions
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 13
Est. completion date March 30, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BAT6021
? infusions
BAT1308
? infusions

Locations

Country Name City State
Australia Liverpool Hospital Liverpool New South Wales
Australia Cabrini Hospital Malvern Melbourne Victoria
Australia Macquarie University Hospital Sydney New South Wales

Sponsors (1)

Lead Sponsor Collaborator
Bio-Thera Solutions

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Pharmacokinetics (PK) Cmax every cycle until cycle 6 (one cycle equals 3 weeks)
Secondary Immunogenicity Presence of ADAs / neutralizing antibodies (NAbs). every cycle until cycle 6 (one cycle equals 3 weeks)
See also
  Status Clinical Trial Phase
Recruiting NCT06223308 - A Study Evaluating the Safety and Efficacy of HB0028 in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Completed NCT05508100 - Dose Confirmation and Dose Expansion Phase 1 Study of IO-108 and IO-108 + Anti-PD-1 in Solid Tumors Phase 1
Not yet recruiting NCT05515185 - B7-H3 Targeting CAR-T Cells Therapy for B7-H3 Positive Solid Tumors Early Phase 1
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT02836600 - A Study of LY3039478 in Japanese Participants With Advanced Solid Tumors Phase 1
Recruiting NCT04890613 - Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation Phase 1
Recruiting NCT04390737 - Evaluate the Safety and Clinical Activity of HH2853 Phase 1/Phase 2
Recruiting NCT05981703 - A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors Phase 1
Recruiting NCT06007482 - A Study of ES009 in Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1
Completed NCT04108676 - Effect of Omeprazole on PK of Fluzoparib in Healthy Male Subjects Phase 1
Recruiting NCT05798611 - Study of ART0380 in Patients With Biologically Selected Solid Tumors Phase 2
Recruiting NCT05076396 - PM14 Administered Intravenously to Patients With Advanced Solid Tumors Phase 1
Recruiting NCT06054932 - Safety, Tolerability, and Immunogenicity of LK101 Alone in Participants With Incurable Solid Tumors Phase 1
Recruiting NCT06008366 - A Phase 1/2 Study of 7MW3711 in Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT04825392 - A Phase Ib Study of HX008 in Patients With Advanced Solid Tumors Phase 1
Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Not yet recruiting NCT06365918 - Study of VG2025 Delivered Intraperitoneally in Patients With Advanced Solid Tumors With Carcinomatosis Phase 1
Recruiting NCT05569057 - A Phase I Trial of SIM1811-03 in Subjects With Advanced Solid Tumors and Cutaneous T-cell Lymphoma Phase 1
Recruiting NCT05461287 - Safety, Tolerability and Pharmacokinetics Study of QLS31904 in Patients With Advanced Solid Tumors Phase 1
Recruiting NCT05443126 - A Study of EP0031 in Patients With Advanced RET-altered Malignancies Phase 1/Phase 2