- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05109650
Assessment of Safety and Preliminary Efficacy With BAT6026 in Solid Tumour Patients
A Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT6026 as Monotherapy and in Combination With BAT1308 in Patients With Advanced Solid Tumours
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Although the success of immune checkpoints like PD-1/PD-L1 and CTLA-4 has provided more alternatives and benefit to cancer patients, there are still much unmet need in tumour patients. That is why novel immunomodulatory drugs with other mechanisms of action still needed to be developed and tested clinically. OX40 is a co-stimulatory immune checkpoint which is contrary to PD-1 or CTLA4. Similar to other TNFSF members, three OX40 molecules were clustered when binding to one OX40L ligand on activated APCs. The clustered OX40s then directly activate NF-kB, PI3K/PKB and NFAT signal pathways to activate CD4+ and CD8+T cells 9. Thus, antibody targeting OX40 should be an agonist antibody which can be crosslinked by FcyR of effector cells. As the mechanism and signal pathways mediated by OX40 to activate T cells are different from those mediated by PD-1 and CTLA-4, targeting on OX40 may provide different clinical benefit for patients than treating with PD-1 and CTLA-4 therapies.
To enhance activation on T cells, combination treatment with PD-1, PD-L1, or CTLA-4 antibodies is a feasible approach for anti-OX40 immunotherapy. The effect of combination treatment of BAT6026 with an anti-PD1 antibody, BAT1308, in mouse tumour model was examined in the in vivo pharmacology study. MC38 murine colon carcinoma cells were inoculated in PD-1/OX40-dual-humanized mice.
Therefore, besides exploration as a monotherapy, finding a combination agent(s) and a suitable indication(s) would also be an encouraging direction for clinical development of BAT6026.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Longxun Jin
- Phone Number: 86-135-8050-6307
- Email: lxjin@bio-thera.com
Study Contact Backup
- Name: Zhaohe Wang, Ph.D
- Phone Number: 86-020-32203220
- Email: zhwang@bio-thera.com
Study Locations
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-
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Kogarah, Australia
- St George private Hospital
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Sydney, Australia
- Blacktown Cancer and Haematology Centre
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Sydney, Australia
- Scientia Clinical Research Limited
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 0.1mg/kg of BAT6026 + 300mg of BAT1308
0.1mg/kg of BAT6026 Ⅳ infusions at cycle 1(monotherapy), and 0.1mg/kg of BAT6026 IV infusions + 300mg of BAT1308 IV infusions(combination therapy) from cycle 2 until end of treatment
|
IV infusions
Other Names:
Ⅳ infusions
Other Names:
|
Experimental: 0.3mg/kg of BAT6026 + 300mg of BAT1308
0.3mg/kg of BAT6026 Ⅳ infusions at cycle 1(monotherapy), and 0.3mg/kg of BAT6026 IV infusions + 300mg of BAT1308 IV infusions(combination therapy) from cycle 2 until end of treatment
|
IV infusions
Other Names:
Ⅳ infusions
Other Names:
|
Experimental: 1mg/kg of BAT6026 + 300mg of BAT1308
1mg/kg of BAT6026 Ⅳ infusions at cycle 1(monotherapy), and 1mg/kg of BAT6026 IV infusions + 300mg of BAT1308 IV infusions(combination therapy) from cycle 2 until end of treatment
|
IV infusions
Other Names:
Ⅳ infusions
Other Names:
|
Experimental: 3mg/kg of BAT6026 + 300mg of BAT1308
3mg/kg of BAT6026 Ⅳ infusions at cycle 1(monotherapy), and 3mg/kg of BAT6026 IV infusions + 300mg of BAT1308 IV infusions(combination therapy) from cycle 2 until end of treatment
|
IV infusions
Other Names:
Ⅳ infusions
Other Names:
|
Experimental: 6mg/kg of BAT6026 + 300mg of BAT1308
6mg/kg of BAT6026 Ⅳ infusions at cycle 1(monotherapy), and 6mg/kg of BAT6026 IV infusions + 300mg of BAT1308 IV infusions(combination therapy) from cycle 2 until end of treatment
|
IV infusions
Other Names:
Ⅳ infusions
Other Names:
|
Experimental: 10mg/kg of BAT6026 + 300mg of BAT1308
10mg/kg of BAT6026 Ⅳ infusions at cycle 1(monotherapy), and 10mg/kg of BAT6026 IV infusions + 300mg of BAT1308 IV infusions(combination therapy) from cycle 2 until end of treatment
|
IV infusions
Other Names:
Ⅳ infusions
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose-limiting toxicity(DLT)
Time Frame: the first cycle of 21 days for monotherapy and the second cycle of another 21 days for combination therapy
|
A DLT is defined as a toxicity occurring during the DLT observation period. Events clearly associated with the underlying disease, disease progression, a concomitant medication, or comorbidity should be excepted, and it should be considered to be at least possibly related to study drug as defined below Grade 5 toxicity; Grade 4 anaemia; Grade 4 thrombocytopenia lasting ≥ 7 days ; Grade 3 thrombocytopenia if associated with clinically significant bleeding (≥ Grade 2 haemorrhage) or with requirement of transfusion of platelets; Grade 4 neutropenia for ≥ 7 days ; ≥ Grade 3 neutropenia associated with infection or febrile neutropenia |
the first cycle of 21 days for monotherapy and the second cycle of another 21 days for combination therapy
|
Serious adverse event(SAE)
Time Frame: Adverse events will be collected from the time of informed consent to 90 days after the last dose or until the initiation of a new cancer treatment.
|
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 within 24 hours of receipt by the PI or designee.
|
Adverse events will be collected from the time of informed consent to 90 days after the last dose or until the initiation of a new cancer treatment.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Prachi Bhave, M.D, Ph.D, Scientia Clinical Research Ltd
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BAT-6026-002-CR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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