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Antibodies

Immunoglobulins

Immunoglobulins, Intravenous

Immunologic Factors

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

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

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

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

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

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

BAT6026

BAT1308

Prachi Bhave, M.D, Ph.D

This is a multicenter, open-label, Phase 1 dose-escalation study of BAT6026, an OX40 monoclonal antibody, combined with the anti-PD-1 IgG4 monoclonal antibody BAT1308 in subjects with advanced solid tumours. After a screening period of up to 28 days, qualified subjects will be enrolled to receive their assigned dose regimen until disease progression or intolerable toxicity, withdrawal of consent, per Investigator decision, or end of study, whichever occurs first. The maximum treatment duration is 1 year. Subjects who remain on treatment in the absence of disease progression for more than 1 year may continue to receive study drug for the next cycle at the maximum of 2 years.

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.

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

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

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.

Bio-Thera Solutions

Antibodies, Monoclonal

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

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

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

BAT6021

Abhijit Pal, M.D, Ph.D

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.

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.

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

A Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT6021 as Mono Therapy or in Combination With BAT1308 in Patients With Advanced Solid Tumors

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.

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.

Presence of ADAs / neutralizing antibodies (NAbs).

First Phase: dose escalation study. It was divided into three dose groups: 100mg, 300mg and 600mg. The safety, tolerance and pharmacokinetics of BAT1308 injection were explored according to the 3+3 dose increasing mode. It is expected that 12-18 cases will be included in the group. Second Phase: dose expansion study. After the completion of dose increment, 300mg tolerated doses were selected for extended research on advanced non-small cell lung cancer, advanced hepatocellular carcinoma and cervical cancer (80-130 cases), so as to provide recommended doses for subsequent clinical trials.

A 21 day treatment cycle was administered every 3 weeks (Q3W) on day 1 of each cycle. Six consecutive dosing cycles are recommended for the dose escalation phase. In the extended study phase, after the end of the 6th treatment cycle, after the risk and benefit are evaluated by the investigator in combination with the clinical practice, if the subjects are still in a state of clinical benefit (including CR, PR and SD), the investigator can decide to appropriately extend the treatment of BAT1308. Until disease progression, unacceptable toxicity, withdrawal of informed consent, loss of follow-up, death, acceptance of new antitumor therapy, termination of treatment by investigator evaluation, or 12 months after initial administration, whichever is the earliest.

Yinbo Zhou

Zhaohe Wang, Ph.D

Suxia Luo, M.D

A phase I dose escalation and cohort expansion study to evaluate the safety, tolerance and pharmacokinetic of BAT1308 injection in patients with advanced solid tumors

This study is a multicenter, open, dose-increasing and dose-expanding phase I clinical study. The dose increasing method of "3 + 3" is used to explore the safety, tolerance and pharmacokinetic characteristics of BAT1308 injection in patients with advanced solid tumors (12-18 cases). After the completion of dose increment, 300mg tolerated doses were selected for extended research on advanced non-small cell lung cancer, advanced hepatocellular carcinoma and cervical cancer (80-130 cases), so as to provide recommended doses for subsequent clinical trials.

Assessment of Safety ,Tolerance and Pharmacokinetics Clinical Efficacy With BAT1308 in Advanced Solid Tumors

A Phase I Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerance and Pharmacokinetic of BAT1308 Injection in Patients With Advanced Solid Tumors

Tolerance evaluation: Dose-limiting toxicity (DLT) is defined as follows: Patients develop the following AE associated with the study drug between day 1 and day 21 after cycle 1 administration: 1)Non-hematological toxicity of grade ≥3 (nausea, vomiting, and diarrhea were relieved within 3 days after supportive treatment, except for infusion reactions that recovered within 2 hours after symptomatic treatment); 2)Grade ≥4 hematologic toxicity (including grade ≥3 neutropenia with fever; However, grade 4 neutropenia requires a duration of ≥7 days to determine DLT); 3) Grade ≥4 thrombocytopenia or grade 3 thrombocytopenia with bleeding.

Safety evaluation indexes: Safety indicators include: vital signs, physical examination, laboratory tests, electrocardiogram, cardiac color ultrasound, adverse events (including immune-related adverse events), etc.

Blood samples were collected from all dose groups at specific time points during treatment, and 2mL blood samples were collected at each time point to detect the concentration level of BAT1308 in serum and study the pharmacokinetic (PK) characteristics of BAT1308 injection. PK blood samples were collected from subjects before and after each dosing in cycles 1 to 6. In the first and fourth cycles, intensive sampling was carried out to study PK characteristics of steady-state studies of single administration and multiple administration, respectively.

All subjects in the dose groups were required to collect blood samples at specific points during treatment, and 3.5ml blood samples were planned for each time point to detect antidrug antibodies in the serum. For blood samples with positive anti-drug antibodies, further testing of titers and neutralizing antibodies is required.

The receptor occupancy of BAT1308 injection was studied by detecting PD-1 receptor binding on T cells in peripheral blood. Subjects in all dose groups required blood samples to be collected at specific points during treatment. Pharmacodynamic receptor occupancy studies were performed only in dose-increasing subjects. 2mL blood samples were collected at each time point, and intensive samples were collected before and at the end of the first cycle, 168h and 336h, respectively, and before the second to sixth cycle.

The antitumor efficacy of BAT1308 was assessed with RECIST1.1 and iRECIST1.1 throughout the trial. Tumor imaging was performed within 28 days prior to initial dosing, and the same imaging technique was used in the same patient at the same site throughout the study period. If there are brain metastases, do head MRI. RECIST 1.1 was used as the main evaluation criterion. Tumor evaluation after dosing was performed at weeks 6 (D42±5), 12 (D84±5), and 18 (D126±5). The extended study tumor assessment was performed every 9 weeks (±7 days) after week 18 until disease progression, withdrawal of informed consent, loss of follow-up, death, acceptance of new antitumor therapy, or up to 12 months after initial administration, whichever occurred first.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessment of Safety and Preliminary Efficacy With BAT6026 in Solid Tumour Patients	NCT05109650	Advanced Solid ...	BAT6026 BAT1308	18 Years -	Bio-Thera Solutions
Assessment of Safety and Preliminary Efficacy With BAT6021 in Solid Tumor Patients	NCT05073484	Advanced Solid ...	BAT6021 BAT1308	18 Years -	Bio-Thera Solutions
Assessment of Safety and Preliminary Efficacy With BAT6026 in Solid Tumour Patients	NCT05109650	Advanced Solid ...	BAT6026 BAT1308	18 Years -	Bio-Thera Solutions
Assessment of Safety ,Tolerance and Pharmacokinetics Clinical Efficacy With BAT1308 in Advanced Solid Tumors	NCT05155722	Advanced Solid ...	BAT1308	18 Years - 75 Years	Bio-Thera Solutions
Assessment of Safety ,Tolerance and Pharmacokinetics Clinical Efficacy With BAT1308 in Advanced Solid Tumors	NCT05155722	Advanced Solid ...	BAT1308	18 Years - 75 Years	Bio-Thera Solutions
Assessment of Safety and Preliminary Efficacy With BAT6021 in Solid Tumor Patients	NCT05073484	Advanced Solid ...	BAT6021 BAT1308	18 Years -	Bio-Thera Solutions

Spots Global Cancer Trial Database for bat1308

Every month we try and update this database with for bat1308 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bat1308

Every month we try and update this database with for bat1308 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bat1308 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.