Advanced Malignant TumorPhase 1NCT05767060

BAT7104 Injection in Patients With Advanced Malignant Tumors.

A Phase 1 study testing BAT7104 injection in people with Advanced Malignant Tumor, run by Bio-Thera Solutions at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A multi-center, open phase Ia/Ib clinical study to evaluate the safety, tolerance, pharmacokinetics and preliminary clinical efficacy of BAT7104 injection in patients with advanced malignant tumors. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Advanced Malignant Tumor
What is being tested?: BAT7104 injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 86 participants
Where: 1 siteChina
Study dates: 20 Jan 2022to 11 Dec 2024
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age: ≥ 18 years old and ≤ 80 years old, gender: male or female;
The investigator evaluated the expected survival period to be at least 3 months;
The requirement of the ECOG physical fitness score is 0 or 1;
Patients with advanced malignant tumors who have failed to receive standard treatment, have no standard treatment, do not tolerate standard treatment or refuse to accept standard treatment confirmed by cytology or pathology;
There must be an evaluable tumor focus in the dose increasing stage, and at least one measurable tumor focus in the dose expanding stage (solid tumors refer to RECIST 1.1 standard, lymphoma refer to Lugano 2014 evaluation standard);
It has sufficient organ and bone marrow reserve function, which is defined as follows:

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System laboratory reference value:
Blood routine (no blood transfusion, no use of hematopoietic stimulating factor and no use of drugs to correct blood cell count within 14 days before the first administration):
Absolute neutrophil count ≥ 1.5 x 109/L;Platelet count ≥ 90 x109/L;Hemoglobin ≥ 90g/L;
Coagulation function:
International standardized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5xULN (without anticoagulant treatment), those who receive oral anticoagulant treatment and whose INR is 2~3 can be included.
Liver function:
Total bilirubin (TBIL) ≤ 1.5xULN;Hepatocellular carcinoma, Gilbert's syndrome, liver metastasis ≤ 2xULN;Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5xULN;Hepatocellular carcinoma, liver metastasis ≤ 5xULN renal function Serum creatinine or Serum creatinine clearance ≤ 1.5xULN or>50ml/min (using Cockcroft-Gault formula, see appendix)
Agree to provide archived pathological tissue or fresh biopsy tumor tissue for the detection of PD-L1, CD47 expression level or receptor occupancy and other pharmacodynamic indicators (not as a necessary inclusion standard); Female patients with fertility must have negative serum pregnancy test within 7 days before the first administration and are willing to take effective birth control/contraception methods to prevent pregnancy during the study period until 6 months after the last administration of the study. Male patients must agree to take effective contraceptive methods during the study period and within 6 months after the last administration of the study; Postmenopausal women must have amenorrhea for at least 12 months before they are considered infertile.

Who cannot join

Have received any anti-CD47 antibody and SIRP within 4 weeks before the first administration α Antibodies or CD47/SIRP α Recombinant protein therapy;
He has received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatment within 4 weeks before the first use of the study drug, with the exception of the following: ① nitrosourea or mitomycin C within 6 weeks before the first use of the study drug; ② Oral fluorouracil and small-molecule targeted drugs are 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever is longer); ③ The systematic treatment of traditional Chinese medicine/proprietary Chinese medicine with clear anti-tumor effect and drugs with immunomodulatory effect (including but not limited to thymosin, interferon, interleukin, etc.) is within 2 weeks before the first use of the study drug;
Those who are participating in or have participated in the experimental drug or medical device intervention clinical research within 4 weeks before the first administration of this study cannot be included; In the survival follow-up stage of the intervention study, if the time between the first administration and the end of the previous study (the last administration) meets the above exclusion criteria, it can be included;
Inoculated or planned to receive live/attenuated vaccine and mRNA vaccine within 4 weeks before screening;
Pregnant or lactating women;
AEs caused by previous anti-tumor therapy are still higher than grade 1 (based on CTCAE v5.0) before the first administration of the study drug (except for AEs such as hair loss and fatigue that cannot be restored to ≤ grade 1 and will remain stable for a long time according to the judgment of the researcher based on clinical actual conditions, except for grade 2 peripheral neurotoxicity, and hypothyroidism stabilized by hormone replacement therapy);

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Those who have had ≥ 3 levels of irAE in the past or have terminated immunotherapy due to any level of irAE;
Primary central nervous system tumor, central nervous system metastasis with related symptoms, meningeal metastasis or previous history of epilepsy should be excluded. Patients with asymptomatic or asymptomatic central nervous system metastasis who have been clinically controlled but have been judged stable by the researcher can be included, but the following conditions must be met at the same time: a The disease was stable ≥ 4 weeks before the first administration; B. No evidence of central nervous system disease progression was found in MRI enhancement of the head within 4 weeks before the first administration; C. The anticonvulsant drugs have been stopped at least 2 weeks before the first administration, and the dosage of prednisone is ≤ 10mg/day or equivalent dose of hormone;
Patients who have undergone major organ surgery (excluding puncture biopsy) or had significant trauma within 4 weeks before the first use of the study drug, or who need to undergo elective surgery during the trial period;
Have a history of tissue or organ transplantation;
Patients with severe infection within 4 weeks before the first medication, including but not limited to infection complications, bacteremia, severe pneumonia, etc. requiring hospitalization; Patients with active infection before the first administration were excluded;
Known history of human immunodeficiency virus (HIV) infection;
Active hepatitis B, untreated chronic hepatitis B or treated but uncontrolled chronic hepatitis B (HBV DNA>200 IU/mL or>103 copies/ml);
Active HCV infected patients (HCV antibody positive and HCV-RNA level higher than the lower limit of detection);
Untreated or under treatment tuberculosis patients, including but not limited to tuberculosis; Those who have received standard anti-tuberculosis treatment and have been confirmed as cured by researchers can be included;
Known to have a history of severe allergy, or known to have had ≥ grade 3 allergic reaction to macromolecular protein preparation/monoclonal antibody, and any component of test drug;
Patients with active, or had a history of autoimmune diseases that may recur (excluding vitiligo, autoimmune thyroid diseases that can be treated with hormone replacement therapy, and type 1 diabetes patients);
Have received systemic glucocorticoid (prednisone>10mg/day or equivalent dose of the same drug) or other immunosuppressive treatment within 14 days before the first use of the study drug, except for the following cases: ① use of local, ocular, intraarticular, intranasal and inhaled glucocorticoid treatment, ② short-term use of glucocorticoid for preventive treatment (such as prevention of contrast agent allergy);
Patients who have a history of non-infectious pneumonia requiring glucocorticoid treatment or who currently have interstitial lung disease within 1 year before the first administration;
There is a history of serious cardio-cerebrovascular disease, including but not limited to: ① heart failure or left ventricular ejection fraction (LVEF)<50% with NYHA grade II or above; ② There are serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, Ⅱ - Ⅲ degree atrioventricular block, etc.; ③ Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other cardiovascular and cerebrovascular events of grade 3 or above occurred within 6 months before the first administration; ④ Hypertension that cannot be controlled clinically (this protocol is defined as that although antihypertensive treatment is adopted, the systolic blood pressure is more than 150 mmHg and/or diastolic blood pressure is more than 100 mmHg after treatment, and has clinical significance after evaluation by the researcher);
Those with the following risk of thrombosis or bleeding:
Myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack occurred within 6 months before the first administration; B. There is a history of deep venous thrombosis, pulmonary embolism or any other serious thromboembolism within 3 months before the first administration (implantable venous infusion port or catheter-derived thrombosis, or superficial venous thrombosis is not considered as "serious" thromboembolism); C. Any life-threatening bleeding event or grade 3 or 4 gastrointestinal/variceal bleeding event requiring blood transfusion, endoscopy or surgical treatment within 3 months before the first administration; D. Other diseases that the researcher believes have a high risk of bleeding or thrombosis in the future;
Patients who are known to have a history of abuse or drug abuse of psychotropic substances and are considered to affect the compliance of this study;
Have a history of hemolytic anemia or Evans syndrome in the past 3 months;
In addition to the tumors at the time of study, there are other active malignant tumors within 3 years before the first administration (not excluding locally cured tumors, such as skin basal cell carcinoma, superficial bladder cancer cancer or breast cancer in situ);
Patients with pleural effusion, pericardial effusion or ascites that are not controlled or need drainage;
Patients who are not suitable for this study according to the researcher.

Trial locations and contacts

1 site in 1 country.

China1 site

Li Zhang
Guangzhou, Guangdong

Other trials in China

About this study

Official title: A Multi-center, Open Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Clinical Efficacy of BAT7104 Injection in Patients With Advanced Malignant Tumors.

A multi-center, open phase Ia/Ib clinical study to evaluate the safety, tolerance, pharmacokinetics and preliminary clinical efficacy of BAT7104 injection in patients with advanced malignant tumors.

Read the detailed description

This is a multi-center, open, dose-increased and dose-expanded phase I clinical study. About 18-42 patients will be recruited from research centers in China. In the stage of dose increase, the safety, tolerance, pharmacokinetics and preliminary clinical efficacy of BAT7104 injection in patients with advanced malignant tumors were investigated by using accelerated titration and "3+3" dose increase design. During the dose increase test, the appropriate dose was selected according to the previous study data of the extended study.

Conditions: Advanced Malignant Tumor
Being tested: BAT7104 injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BAT7104 injectionDrug
Also called Recombinant anti-PD-L1/CD47 bispecific antibody injection
According to the protocol, each dose group is given intravenous infusion at the rate of mg/kg, and the recommended infusion time is ≥ 60 minutes. Once every two weeks (Q2W), on the first day of each cycle.

Study groups in NCT05767060
Study group	Role	What they receive
BAT7104 Injection 0.1 mg/kg	Experimental	frequency: Q2W Receives: Drug: BAT7104 injection
BAT7104 Injection 0.3 mg/kg	Experimental	frequency: Q2W Receives: Drug: BAT7104 injection
BAT7104 Injection 1 mg/kg	Experimental	frequency: Q2W Receives: Drug: BAT7104 injection
BAT7104 Injection 3 mg/kg	Experimental	frequency: Q2W Receives: Drug: BAT7104 injection
BAT7104 Injection 10 mg/kg	Experimental	frequency: Q2W Receives: Drug: BAT7104 injection
BAT7104 Injection 20 mg/kg	Experimental	frequency: Q2W Receives: Drug: BAT7104 injection
BAT7104 Injection 40 mg/kg	Experimental	frequency: Q2W Receives: Drug: BAT7104 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose limiting toxicity (DLT),
umber of subjects who experience DLT events during 28 days. Toxicity will be graded according to CTCAE, Version 5.0.
Measured: A minimum of 28 days after first dose of BAT-7104
Adverse Events (AEs)
Incidence of treatment -related AEs as assessed by CTCAE, Version 5.0.
Measured: AE needs continuous monitoring and evaluation from the first administration to 90 days after the last administration or before receiving new anti-tumor treatment.

Secondary outcomes (8)

Cmax,
Maximum observed plasma or serum concentration
Measured: up to Cycle 6, each cycle is 14 days
Anti-drug antibodies (ADA) and neutralizing antibodies (NAb)
Measured: up to Cycle 6, each cycle is 14 days
Objective response rate (ORR)
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
Measured: 12 months (anticipated)
Tmax (Time to reach maximum serum concentration)
Time to Maximum concentration
Measured: up to Cycle 6, each cycle is 14 days
AUC0-inf after Cycle 1 administration and AUC0- λ after Cycle 6 administration
Measured: up to Cycle 6, each cycle is 14 days
Systemic Clearance (CL)
Systemic dose clearance
Measured: up to Cycle 6, each cycle is 14 days
Vss (volume of distribution at steady state)
Amount of drug in the body divided by plasma concentration
Measured: up to Cycle 6, each cycle is 14 days
t1/2 (terminal half-life)
Apparent terminal-phase disposition half-life.
Measured: up to Cycle 6, each cycle is 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jan 202211 Dec 2024

First posted14 Mar 2023
Study start20 Jan 2022
Primary completion11 Dec 2024
Study completion11 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Malignant 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05767060
Sponsor's protocol ID: BAT-7104-001-CR
Status last verified: Dec 2025
First submitted: 10 Feb 2023
Last updated: 2 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
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Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 1
Advanced or Recurrent Solid Tumors Treated With SHetA2
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All Advanced Malignant Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Open Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Clinical Efficacy of BAT7104 Injection in Patients With Advanced Malignant Tumors.
ClinicalTrials.gov ID: NCT05767060
Acronym / sponsor ID: BAT-7104-001-CR
Conditions: Advanced Malignant Tumor
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 86 participants (actual)
Lead sponsor: Bio-Thera SolutionsIndustry (pharma, biotech, devices)
Collaborators: Sun Yat-Sen University Cancer Center
Study start: 20 Jan 2022 (actual)
Primary completion: 11 Dec 2024 (actual)
Study completion: 11 Dec 2024 (actual)
First posted: 14 Mar 2023 (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.

A multi-center, open phase Ia/Ib clinical study to evaluate the safety, tolerance, pharmacokinetics and preliminary clinical efficacy of BAT7104 injection in patients with advanced malignant tumors.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 7

Arm	Type	Receives
BAT7104 Injection 0.1 mg/kg	Experimental	Drug: BAT7104 injectionfrequency: Q2W
BAT7104 Injection 0.3 mg/kg	Experimental	Drug: BAT7104 injectionfrequency: Q2W
BAT7104 Injection 1 mg/kg	Experimental	Drug: BAT7104 injectionfrequency: Q2W
BAT7104 Injection 3 mg/kg	Experimental	Drug: BAT7104 injectionfrequency: Q2W
BAT7104 Injection 10 mg/kg	Experimental	Drug: BAT7104 injectionfrequency: Q2W
BAT7104 Injection 20 mg/kg	Experimental	Drug: BAT7104 injectionfrequency: Q2W
BAT7104 Injection 40 mg/kg	Experimental	Drug: BAT7104 injectionfrequency: Q2W

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Age: ≥ 18 years old and ≤ 80 years old, gender: male or female;
The investigator evaluated the expected survival period to be at least 3 months;
The requirement of the ECOG physical fitness score is 0 or 1;
Patients with advanced malignant tumors who have failed to receive standard treatment, have no standard treatment, do not tolerate standard treatment or refuse to accept standard treatment confirmed by cytology or pathology;
There must be an evaluable tumor focus in the dose increasing stage, and at least one measurable tumor focus in the dose expanding stage (solid tumors refer to RECIST 1.1 standard, lymphoma refer to Lugano 2014 evaluation standard);

Key exclusion criteria (27 listed)

Have received any anti-CD47 antibody and SIRP within 4 weeks before the first administration α Antibodies or CD47/SIRP α Recombinant protein therapy;
He has received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatment within 4 weeks before the first use of the study drug, with the exception of the following: ① nitrosourea or mitomycin C within 6 weeks before the first use of the study drug; ② Oral fluorouracil and small-molecule targeted drugs are 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever is longer); ③ The systematic treatment of traditional Chinese medicine/proprietary Chinese medicine with clear anti-tumor effect and drugs with immunomodulatory effect (including but not limited to thymosin, interferon, interleukin, etc.) is within 2 weeks before the first use of the study drug;
Those who are participating in or have participated in the experimental drug or medical device intervention clinical research within 4 weeks before the first administration of this study cannot be included; In the survival follow-up stage of the intervention study, if the time between the first administration and the end of the previous study (the last administration) meets the above exclusion criteria, it can be included;
Inoculated or planned to receive live/attenuated vaccine and mRNA vaccine within 4 weeks before screening;
Pregnant or lactating women;

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
BAT7104 injectionAlso: Recombinant anti-PD-L1/CD47 bispecific antibody injectionAccording to the protocol, each dose group is given intravenous infusion at the rate of mg/kg, and the recommended infusion time is ≥ 60 minutes. Once every two weeks (Q2W), on the first day of each cycle.	Drug	BAT7104 Injection 0.1 mg/kg, BAT7104 Injection 0.3 mg/kg, BAT7104 Injection 1 mg/kg, BAT7104 Injection 10 mg/kg, BAT7104 Injection 20 mg/kg, BAT7104 Injection 3 mg/kg, BAT7104 Injection 40 mg/kg

Primary outcome

Dose limiting toxicity (DLT),
Time frame: A minimum of 28 days after first dose of BAT-7104
umber of subjects who experience DLT events during 28 days. Toxicity will be graded according to CTCAE, Version 5.0.
Adverse Events (AEs)
Time frame: AE needs continuous monitoring and evaluation from the first administration to 90 days after the last administration or before receiving new anti-tumor treatment.
Incidence of treatment -related AEs as assessed by CTCAE, Version 5.0.

8 secondary outcomes

Cmax,
Time frame: up to Cycle 6, each cycle is 14 days
Anti-drug antibodies (ADA) and neutralizing antibodies (NAb)
Time frame: up to Cycle 6, each cycle is 14 days
Objective response rate (ORR)
Time frame: 12 months (anticipated)
Tmax (Time to reach maximum serum concentration)
Time frame: up to Cycle 6, each cycle is 14 days
AUC0-inf after Cycle 1 administration and AUC0- λ after Cycle 6 administration
Time frame: up to Cycle 6, each cycle is 14 days
Systemic Clearance (CL)
Time frame: up to Cycle 6, each cycle is 14 days
Vss (volume of distribution at steady state)
Time frame: up to Cycle 6, each cycle is 14 days
t1/2 (terminal half-life)
Time frame: up to Cycle 6, each cycle is 14 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
Individual participant dataSharing planned: No

Related trials for Advanced Malignant Tumor

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 1
Advanced or Recurrent Solid Tumors Treated With SHetA2
Solid Tumor, Adult

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.

Li Zhang principal investigator

Sun Yat-Sen University Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BAT7104 injection in people with Advanced Malignant Tumor, run by Bio-Thera Solutions at 1 site in China.

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 14 inclusion and 27 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: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 28 days after first dose of BAT-7104). 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?

On the ClinicalTrials.gov record for NCT05767060.

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 2 Dec 2025.