Advanced Solid TumorPhase 1NCT05073484
Assessment of Safety and Preliminary Efficacy With BAT6021 in Solid Tumor Patients
A Phase 1 study testing BAT6021 and BAT1308 in people with Advanced Solid Tumor, run by Bio-Thera Solutions at 3 sites in Australia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- BAT6021 and BAT1308
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesAustralia
- Study dates
- 29 Oct 2021to 30 Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Liverpool Hospital
Liverpool, New South Wales
Cabrini Hospital Malvern
Melbourne, Victoria
Macquarie University Hospital
Sydney, New South Wales
About this study
Official title: 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
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.
Read the detailed 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.
- Conditions
- Advanced Solid Tumor
- Being tested
- BAT6021, BAT1308
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAT6021Drug
Also called Recombinant Humanized Anti-TIGIT Antibody Solution for Injection
Ⅳ infusions
BAT1308Drug
Also called Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection
Ⅳ infusions
| Study group | Role | What they receive |
|---|---|---|
| 10 mg of BAT6021 | Experimental | BAT6021 100mg/vial，10mg Ⅳ infusions Receives: Drug: BAT6021 |
| 30 mg of BAT6021 | Experimental | BAT6021 100mg/vial，30mg Ⅳ infusions Receives: Drug: BAT6021 |
| 100 mg of BAT6021 | Experimental | BAT6021 100mg/vial，100mg Ⅳ infusions Receives: Drug: BAT6021 |
| 300 mg of BAT6021 | Experimental | BAT6021 100mg/vial，300mg Ⅳ infusions Receives: Drug: BAT6021 |
| 600 mg of BAT6021 | Experimental | BAT6021 100mg/vial，600mg Ⅳ infusions Receives: Drug: BAT6021 |
| 900 mg of BAT6021 | Experimental | BAT6021 100mg/vial，900mg Ⅳ infusions Receives: Drug: BAT6021 |
| 100mg BAT6021+300mg BAT1308 | Experimental | BAT6021 100mg/vial，BAT1308 100mg/vial ; BAT6021 100mg+BAT1308 300mg Ⅳ infusions Receives: Drug: BAT6021; Drug: BAT1308 |
| 300mg BAT6021+300mg BAT1308 | Experimental | BAT6021 100mg/vial，BAT1308 100mg/vial ; BAT6021 300mg+BAT1308 300mg Ⅳ infusions Receives: Drug: BAT6021; Drug: BAT1308 |
| 600mg BAT6021+300mg BAT1308 | Experimental | BAT6021 100mg/vial，BAT1308 100mg/vial ; BAT6021 600mg+BAT1308 300mg Ⅳ infusions Receives: Drug: BAT6021; Drug: BAT1308 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Cmax
Measured: every cycle until cycle 6 (one cycle equals 3 weeks)
Immunogenicity
Presence of ADAs / neutralizing antibodies (NAbs).
Measured: every cycle until cycle 6 (one cycle equals 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start29 Oct 2021
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Why it stopped: Based on the disclosed global research data on the same target drugs, the company has carefully considered and decided to terminate the project to optimize the existing research pipeline.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Thera Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abhijit Pal, M.D, Ph.D, Principal investigator, Medical Oncologist at cancer Therapy, Liverpool Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073484
- Sponsor's protocol ID
- BAT-6021-002-CR
- Status last verified
- Oct 2023
- First submitted
- 9 Sep 2021
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05073484
- Acronym / sponsor ID
- BAT-6021-002-CR
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on the disclosed global research data on the same target drugs, the company has carefully considered and decided to terminate the project to optimize the existing research pipeline.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Bio-Thera SolutionsIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 10 mg of BAT6021 | Experimental | Drug: BAT6021BAT6021 100mg/vial，10mg Ⅳ infusions |
| 30 mg of BAT6021 | Experimental | Drug: BAT6021BAT6021 100mg/vial，30mg Ⅳ infusions |
| 100 mg of BAT6021 | Experimental | Drug: BAT6021BAT6021 100mg/vial，100mg Ⅳ infusions |
| 300 mg of BAT6021 | Experimental | Drug: BAT6021BAT6021 100mg/vial，300mg Ⅳ infusions |
| 600 mg of BAT6021 | Experimental | Drug: BAT6021BAT6021 100mg/vial，600mg Ⅳ infusions |
| 900 mg of BAT6021 | Experimental | Drug: BAT6021BAT6021 100mg/vial，900mg Ⅳ infusions |
| 100mg BAT6021+300mg BAT1308 | Experimental | Drug: BAT6021, Drug: BAT1308BAT6021 100mg/vial，BAT1308 100mg/vial ; BAT6021 100mg+BAT1308 300mg Ⅳ infusions |
| 300mg BAT6021+300mg BAT1308 | Experimental | Drug: BAT6021, Drug: BAT1308BAT6021 100mg/vial，BAT1308 100mg/vial ; BAT6021 300mg+BAT1308 300mg Ⅳ infusions |
| 600mg BAT6021+300mg BAT1308 | Experimental | Drug: BAT6021, Drug: BAT1308BAT6021 100mg/vial，BAT1308 100mg/vial ; BAT6021 600mg+BAT1308 300mg Ⅳ infusions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAT6021Also: Recombinant Humanized Anti-TIGIT Antibody Solution for InjectionⅣ infusions | Drug | 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 |
| BAT1308Also: Recombinant Anti-PD-1 Humanized Monoclonal Antibody InjectionⅣ infusions | Drug | 100mg BAT6021+300mg BAT1308, 300mg BAT6021+300mg BAT1308, 600mg BAT6021+300mg BAT1308 |
Primary outcome
Dose-limiting toxicity(DLT)
Time frame: A minimum of 21 days after first dose of BAT6021
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.
Serious adverse event（SAE）
Time frame: 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 (or its designee) within 24 hours of receipt by the PI or designee.
2 secondary outcomes
Pharmacokinetics (PK)
Time frame: every cycle until cycle 6 (one cycle equals 3 weeks)
Immunogenicity
Time frame: every cycle until cycle 6 (one cycle equals 3 weeks)
Results and safety
The study was stopped early (reason given: Based on the disclosed global research data on the same target drugs, the company has carefully considered and decided to terminate the project to optimize the existing research pipeline.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No. no plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abhijit Pal, M.D, Ph.D principal investigator
Medical Oncologist at cancer Therapy, Liverpool Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAT6021 and BAT1308 in people with Advanced Solid Tumor, run by Bio-Thera Solutions at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Based on the disclosed global research data on the same target drugs, the company has carefully considered and decided to terminate the project to optimize the existing research pipeline.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity(DLT) (time frame: A minimum of 21 days after first dose of BAT6021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.