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Advanced Solid TumorPhase 1NCT05148325

Assessment of Safety ,Tolerance and Pharmacokinetics Clinical Efficacy With BAT4706 in Advanced Solid Tumors

A Phase 1 study testing BAT4706 in people with Advanced Solid Tumor and Melanoma, 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 Phase I Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetics of BAT4706 Injection in Patients With Advanced Solid Tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor, Melanoma
What is being tested?
BAT4706
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteChina
Study dates
2 Sep 2021to 5 Nov 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 75 years old (including boundary value), male or female;
  • Voluntarily sign informed consent;
  • Study population: advanced patients diagnosed by pathology and without effective standard treatment or standard treatment failure or standard treatment intolerance or refuse standard treatment.Patients with malignant solid tumors. (the extended study phase is mainly for patients with advanced melanoma);
  • According to recist1.1 standard, there is at least one measurable tumor focus;
  • ECOG score shall be 0 or 1;
  • The investigator assessed the expected survival ≥ 12 weeks;
  • Have sufficient organ and bone marrow functions as below:Blood routine (no blood transfusion, no hematopoietic stimulator, and no medication to correct blood count within 14 days prior to first dosing),Neutrophil absolute count (ANC) ≥1.5×109 /L, Platelet count ≥75×109/L, Hemoglobin ≥90g/L, Blood coagulation function Prothrombin time (PT) or International standardized ratio (INR) and activated partial thrombin time (APTT) ≤ 1.5×ULN, Liver function Total bilirubin (TBIL) ≤2×ULN ,Alanine aminotransferase (ALT), aspartate aminotransferase (AST) -- ≤3×ULN,Serum Creatinine ≤1.5×ULN ，renal function Serum creatinine clearance rate \& GT; 60ml/min (Cockcroft-Gault formula, see appendix)
  • Female patients with fertility must have negative serum pregnancy test during screening, and agree to take effective birth control / contraception to prevent pregnancy from the study period to 6 months after the last administration. Male patients must agree to take effective contraceptive methods from the study period to 6 months after the last administration.

Who cannot join

  • Have received experimental drug treatment or participated in clinical research of medical devices within 4 weeks before the first administration of study drugs Research;
  • Received chemotherapy, radiotherapy, Biological therapy, endocrine therapy, immunotherapy, and other anti-tumor treatments within 4 weeks before the first administration of the study drug, except: 1. Nitrosourea or mitomycin C within 6 weeks prior to the first use of the study drug. 2. Oral fluorouracil and small molecule targeted drugs within 2 weeks or 5 half lives,Whichever is longer, etc.). 3. Traditional Chinese medicine/traditional Chinese patent medicines with definite anti-tumor effect, and drugs with immunomodulatory effect (including but not limited to thymosin Interferons, interleukins, etc.) within 2 weeks prior to the first use of the study drug. 4. Palliative radiotherapy within 2 weeks prior to the first use of the study drug.
  • Failure of CTLA-4 monoclonal antibody treatment in the past;
  • Before the first administration of the study drug, the AE (ctcae5.0) caused by previous antitumor treatment was still > grade 1, hair loss and menstrual stimulation Except those with stable immune hypothyroidism controlled by hormone replacement therapy;
  • Received interventional therapy and major surgery (such as craniotomy, thoracotomy or laparotomy) within 4 weeks before the first administration of the study drug;Surgery is defined here as grade 3 and 4 surgery;
  • Have a history of organ transplantation;
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  • Central nervous system or meningeal metastasis;
  • If other malignant tumors have been diagnosed in recent 5 years, or the previous malignant tumors have been cured for less than 5 years, the time of the first pathological diagnosis shall prevail Subject to. Except for radical skin basal cell carcinoma, cutaneous squamous cell carcinoma or in situ carcinoma, such as in situ breast cancer, Cervical carcinoma in situ);
  • Patients with ocular melanoma;
  • Patients with esophageal or gastric variceal bleeding in the past 6 months, or the investigator assessed the risk of bleeding;
  • Serious cardiovascular disease occurred within 6 months before the first medication: the New York Heart Association rating (NYHA) is 2 Heart failure of grade and above, left ventricular ejection fraction (LVEF) < 50%, unstable arrhythmia or unstable heart Colic and uncontrollable hypertension (this protocol is defined as contraction after treatment despite optimal antihypertensive treatment Blood pressure > 150mmhg and / or diastolic blood pressure > 100mmhg, and the investigator's evaluation is of clinical significance);
  • Patients with a history of autoimmune diseases; Had splenectomy or splenic irradiation;
  • Drugs with immunomodulatory effect (e.g. thymosin, interferon, interleukin) were used within 2 weeks before the first administration of the study drug Hormone) or hormone (equivalent dose > prednisone 10mg / day);
  • Untreated or under treatment tuberculosis patients, including but not limited to tuberculosis; Those who have received standardized anti-tuberculosis treatment and have been confirmed by researchers as cured can be included;
  • Patients who have experienced severe infections within 4 weeks prior to the first medication use, including but not limited to infection complications requiring hospitalization, bacteremia, severe pneumonia, etc; Exclude patients with active infections before the first administration;
  • Patients with a history of non infectious pneumonia requiring glucocorticoid treatment or current interstitial lung disease within one year before the first administration;
  • Patients with uncontrolled or requiring drainage of pleural effusion, pericardial effusion, or abdominal effusion;
  • Individuals with the following risks of thrombosis or bleeding:
  • Have experienced myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack within 6 months before the first administration;
  • A history of deep venous thrombosis, pulmonary embolism, or any other severe thromboembolism within 3 months prior to the first administration (implantable venous infusion port or catheter derived thrombosis, or superficial venous thrombosis is not considered "severe" thromboembolism);
  • Any life-threatening bleeding event or grade 3 or 4 gastrointestinal/variceal bleeding event requiring blood transfusion, endoscopy, or surgical treatment within 3 months prior to the first administration;
  • Investigator believe that other diseases with a higher risk of bleeding or thrombosis in the future
  • Patients with active tuberculosis; Active infections requiring intravenous antibiotic treatment;
  • People infected with the following diseases: human immunodeficiency virus (HIV) infection; Treponema pallidum antibody positive; hepatitis B virus Infected persons were positive for hepatitis B surface antigen (HBsAg) and hepatitis B virus deoxyribonucleic acid (HBV DNA) detection > 2000iu / ml (or 1 × 104 copies / ml); HCV infected persons [HCV antibody and disease];Viral RNA (HCV RNA) test results were positive];
  • Inoculated within 4 weeks before the first medication, or planned to receive live / attenuated vaccine during the study period;
  • Known hypersensitivity to any monoclonal antibody;
  • Known history of psychotropic substance abuse or drug abuse;
  • Pregnant or lactating women;
  • Other patients considered by the investigator as unsuitable to participate in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing cancer hospital

    Beijing

Other trials in China

About this study

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetics of BAT4706 Injection in Patients With Advanced Solid Tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetics of BAT4706 Injection in Patients With Advanced Solid Tumors.

Read the detailed description

This study is a single center, 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 PK characteristics of BAT4706 injection in patients with advanced solid tumors. After the completion of dose increment, 1-2 tolerated doses were selected for extended research on melanoma (20-40 cases), so as to provide recommended doses for subsequent clinical trials.

Being tested
BAT4706
Medical subject headings
Melanoma

What participants receive

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

  • BAT4706Drug

    Also called BAT 4706

    The administration cycle was proposed to be 3 weeks (Q3W), i.e., 21 days in a cycle, and the first 4 cycles were administered on the first day of each cycle.

Study groups in NCT05148325
Study groupRoleWhat they receive
Single groupExperimentalFirst Phase: dose escalation study. It was divided into six dose groups: 0.1mg/kg, 0.3mg/kg, 0.5mg/kg ,1.0mg/kg, 3.0mg/kg and 10.0mg/kg. The safety, tolerability and pharmacokinetics of bat4706 injection were explored according to the 3 + 3 dose increasing mode. It is expected that 18-36 cases will be included in the group Second Phase: dose expansion study. After the completion of dose increment, 1-2 tolerated doses were selected for extended research on melanoma (20-40 cases), so as to provide recommended doses for subsequent clinical trials
Receives: Drug: BAT4706

What is being measured

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

  1. Explore the maximum tolerated dose (MTD)

    To evaluate the safety and tolerance of BAT4706 injection in patients with advanced solid tumors, explore the maximum tolerated dose (MTD), and provide the recommended dose for subsequent clinical trials.

    Measured: 21 days after first dosing

Secondary outcomes (19)

  1. Cmax

    Single dose PK characteristics

    Measured: 126 days after first dosing

  2. Tmax

    Single dose PK characteristics

    Measured: 126 days after first dosing

  3. T1/2

    PK characteristics

    Measured: 126 days after first dosing

  4. CL

    Single dose PK characteristics

    Measured: 126 days after first dosing

  5. Vd

    Single dose PK characteristics

    Measured: 126 days after first dosing

  6. AUC(0-τ)

    Single dose PK characteristics

    Measured: 126 days after first dosing

  7. AUC(0-∞)

    Single dose PK characteristics

    Measured: 126 days after first dosing

  8. Cmax

    Multiple doses PK characteristics

    Measured: 126 days after first dosing

  9. Tmax

    Multiple doses PK characteristics

    Measured: 126 days after first dosing

  10. T1/2

    Multiple doses PK characteristics

    Measured: 126 days after first dosing

  11. CL

    Multiple doses PK characteristics

    Measured: 126 days after first dosing

  12. MRT

    Multiple doses PK characteristics

    Measured: 126 days after first dosing

  13. DF

    Multiple doses PK characteristics

    Measured: 126 days after first dosing

  14. ADA antibody

    immunogenicity

    Measured: 126 days after first dosing

  15. Nab positive

    immunogenicity

    Measured: 126 days after first dosing

  16. ORR

    Tumor evaluation after administration will be performed at weeks 6, 12, and 18.

    Measured: 126 days after first dosing

  17. BORR

    Tumor evaluation after administration will be performed at weeks 6, 12, and 18.

    Measured: 126 days after first dosing

  18. DOR

    Tumor evaluation after administration will be performed at weeks 6, 12, and 18.

    Measured: 126 days after first dosing

  19. PFS

    Tumor evaluation after administration will be performed at weeks 6, 12, and 18.

    Measured: 126 days after first dosing

Timeline

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

  1. First posted8 Dec 2021
  2. Study start2 Sep 2021
  3. Primary completion5 Nov 2024
  4. Study completion5 Nov 2024

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05148325
Sponsor's protocol ID
BAT-4706-001-CR
Status last verified
Mar 2026
First submitted
3 Nov 2021
Last updated
1 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BAT4706 in people with Advanced Solid Tumor and Melanoma, 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 8 inclusion and 29 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 1 Apr 2026. 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?

Explore the maximum tolerated dose (MTD) (time frame: 21 days after first dosing). 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 NCT05148325.

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 1 Apr 2026.

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