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Advanced Solid TumorPhase 1NCT06139536

Assessment of Safety, Tolerability and Pharmacokinetics With BAT4706 and BAT1308 in Advanced Solid Tumors Patients

A Phase 1 study testing BAT4706 Injection and BAT1308 Injection in people with Advanced Solid Tumor, run by Bio-Thera Solutions at 3 sites 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

This is a Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BAT4706 Injection Combined With BAT1308 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
What is being tested?
BAT4706 Injection and BAT1308 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
3 sitesChina
Study dates
6 Mar 2024to 17 Mar 2026
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

  • Voluntary signing of informed consent.
  • Study population:
  • Dose increasing stage:Patients with advanced malignant solid tumors who have been pathologically confirmed, have failed to standard treatment, or are intolerant to standard treatment.
  • Dose expansion stage: Divided into 3 queues:
  • Queue A: Patient with locally advanced or metastatic non-small cell lung cancer (NSCLC) confirmed by pathology, failed to standard treatment, or are intolerant to standard treatment. And it must meet the following requirements: a) Previous PD-L1 test results have been obtained; Or b) Provide previously stored tumor tissue samples or fresh biopsy tumor lesion tissue for PD-L1 testing at the site before the first medication use;
  • Queue B: Advanced microsatellite stable (pMMR/MSS) colorectal cancer confirmed by pathology, with disease progression after receiving at least 2 standard chemotherapy regimens/lines, and no liver metastasis or resection/ablation liver metastasis.
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  • Queue C: Patient with Hepatocellular carcinoma confirmed by pathology, refractory to at least 1 line of previous systemic treatment, and intolerant to this treatment.
  • An evaluable tumor focus was necessary in the dose escalation stage, and at least one measurable tumor focus in the dose expanding stage(according to RECIST 1.1 standard).
  • ECOG should be 0-1 in the dose escalation stage, and be 0-2 in the dose expanding stage.
  • The expected survival period is more than 12 weeks base on the evaluation of the investigator.
  • Enough organs, bone marrow reserve function.
  • Female patients with fertility must undergo a serum pregnancy test during the screening period, and the result is negative. Patient must agree to take effective contraceptive methods to prevent pregnancy.

Who cannot join

  • Have received any other clinical trial treatment or participated in a medical device clinical study within 4 weeks prior to the first administration of the study drug.
  • Previously failed to receive CTLA-4 monoclonal antibody treatment.
  • Received other tumor treatments within 4 weeks prior to the first administration of the study drug, such as chemotherapy, radiotherapy (palliative radiotherapy must be completed within 2 weeks prior to the first administration), targeted therapy/immunotherapy (with a minimum interval of 4 weeks or at least 5 half-lives, whichever is shorter), hormone therapy (excluding alternative therapy).
  • Prior to the first administration of the investigational drug, there were still cases of AE caused by previous anti-tumor therapy that were greater than level 1 (CTCAE5.0).
  • Having undergone major surgery (such as craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first administration of the study drug, major surgery is defined as a level 3 or 4 surgery; Individuals with a history of organ transplant surgery.
  • Primary central nervous system tumor or symptomatic central nervous system metastasis, meningeal metastasis, or previous history of epilepsy. Excluding patients with central nervous system metastasis who are clinically asymptomatic or have symptoms but have been judged stable by investigator.
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  • If other malignant tumors have been diagnosed within the past 5 years, or if previous malignant tumors have been cured for less than 5 years, the first pathological diagnosis shall prevail. Except radical skin basal cell carcinoma, skin squamous cell carcinoma or carcinoma in situ (such as breast cancer in situ, cervical carcinoma in situ).
  • Severe cardiovascular disease: Heart failure with a New York Heart Association(NYHA) rating of 2 or above, left ventricular ejection fraction (LVEF) less than 50%, unstable arrhythmia or unstable angina, uncontrollable hypertension (defined in this protocol as systolic blood pressure>150mmHg and/or diastolic blood pressure>100mmHg after treatment, although the optimal antihypertensive treatment is used).
  • Patients with a history of autoimmune diseases (those who undergo thyroid hormone replacement therapy to control stable hypothyroidism can be included in the group); Patients who are using immunosuppressive agents or systemic or absorbable local hormone therapy to achieve immunosuppressive effects (dosage>10mg/day of prednisone or other therapeutic hormones) and continue to use the study drug within 2 weeks before the first administration.
  • Active infections with clinical significance that require intravenous antibiotics, including active pulmonary tuberculosis patients.
  • Patients with uncontrolled or requiring drainage of pleural, pericardial, or abdominal effusion.
  • Individuals at risk of thrombosis or bleeding.
  • Individuals infected with the following diseases: human immunodeficiency virus (HIV) infection; Treponema pallidum antibody positive; Active hepatitis B virus infected; Hepatitis C virus infected.
  • Received or planned to receive live/attenuated vaccines within 4 weeks prior to screening or during the study period.
  • Known to have experienced severe hypersensitivity reactions to any monoclonal antibody.
  • Patients who have a known history of abuse or drug use of psychotropic substances and are believed to affect compliance with this study.
  • Pregnant or lactating women.
  • The study participants who were considered unsuitable for the study by investigator.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Linyi Cancer Hospital

    Linyi, Shandong, 276002

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

  • The First Affiliated Hospital of Henan University of Science and Technology

    Zhengzhou, Henan, 450052

Other trials in China

About this study

Official title: A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BAT4706 Injection Combined With BAT1308 Injection in Patients With Advanced Solid Tumors

This is a Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BAT4706 Injection Combined With BAT1308 Injection in Patients With Advanced Solid Tumors.

Read the detailed description

The goal of this interventional study is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BAT4706 injection combined with BAT1308 injection in patients with advanced solid tumors, explore the maximum tolerable dose. The study is generally divided into two stages. In the first stage, the "3+3" dose increasing rule is proposed to explore the safety and tolerability, subject will be given BAT1308 injection and BAT4706 injection through Intravenous infusion in the first four cycles, and then maintain administration of BAT1308 monotherapy after four cycles until 18 cycles; In the second stage, based on the preliminary safety and efficacy results of the previous stage, appropriate doses and tumor types were selected for extended research, in order to further explore the safety and clinical effectiveness of BAT4706 injection and BAT1308 injection in the combined administration mode.

Being tested
BAT4706 Injection, BAT1308 Injection

What participants receive

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

  • BAT4706 InjectionDrug

    Also called Fc-glycosylated recombinant fully humanized anti-CTLA-4 monoclonal antibody injection

    Intravenous infusion, 3 weeks one cycle(Q3W), Administer on the first day of each cycle. In the first four cycles, administration starting with BAT1308, and then administering BAT4706 on the same day. Maintain administration of BAT1308 monotherapy after four cycles.

  • BAT1308 InjectionDrug

    Also called Recombinant humanized anti PD-1 monoclonal antibody injection

    Intravenous infusion, 3 weeks one cycle(Q3W), Administer on the first day of each cycle. In the first four cycles, administration starting with BAT1308, and then administering BAT4706 on the same day. Maintain administration of BAT1308 monotherapy after four cycles.

Study groups in NCT06139536
Study groupRoleWhat they receive
A/ Standard 3+3 1.0mg/kg of BAT4706 with 300mg of BAT1308ExperimentalDrug: BAT4706 injection, Dosage: 1.0mg/kg, Frequency: once every 3 weeks, Duration: 3 month. Drug: BAT1308 injection, Dosage: 300mg, Frequency: once every 3 weeks, Duration: 1 year.
Receives: Drug: BAT4706 Injection; Drug: BAT1308 Injection
B/ Standard 3+3 2.0mg/kg of BAT4706 with 300mg of BAT1308ExperimentalDrug: BAT4706 injection, Dosage: 2.0mg/kg, Frequency: once every 3 weeks, Duration: 3 month. Drug: BAT1308 injection, Dosage: 300mg, Frequency: once every 3 weeks, Duration: 1 year.
Receives: Drug: BAT4706 Injection; Drug: BAT1308 Injection
C/ Standard 3+3 3.0mg/kg of BAT4706 with 300mg of BAT1308ExperimentalDrug: BAT4706 injection, Dosage: 3.0mg/kg, Frequency: once every 3 weeks, Duration: 3 month. Drug: BAT1308 injection, Dosage: 300mg, Frequency: once every 3 weeks, Duration: 1 year.
Receives: Drug: BAT4706 Injection; Drug: BAT1308 Injection
D/ Standard 3+3 6.0mg/kg of BAT4706 with 300mg of BAT1308ExperimentalDrug: BAT4706 injection, Dosage: 6.0mg/kg, Frequency: once every 3 weeks, Duration: 3 month. Drug: BAT1308 injection, Dosage: 300mg, Frequency: once every 3 weeks, Duration: 1 year.
Receives: Drug: BAT4706 Injection; Drug: BAT1308 Injection
E/ Standard 3+3 10.0mg/kg of BAT4706 with 300mg of BAT1308ExperimentalDrug: BAT4706 injection, Dosage: 10mg/kg, Frequency: once every 3 weeks, Duration: 3 month. Drug: BAT1308 injection, Dosage: 300mg, Frequency: once every 3 weeks, Duration: 1 year.
Receives: Drug: BAT4706 Injection; Drug: BAT1308 Injection

What is being measured

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

  1. Dose-limiting toxicity (DLT)

    The following AEs related to the study drug occurred from day 1 to day 21 after administration in the first cycle:

    ≥grade 3 of non hematological toxicity (except for nausea, vomiting, and diarrhea that can be relieved within 3 days of supportive treatment, and those who recover within 2 hours of symptomatic treatment of infusion reactions); ≥grade 4 of Hematological toxicity(including ≥ 3 grade neutropenia with fever; however, grade 4 neutropenia requires a duration of ≥ 7 days to determine DLT);≥ grade 4 thrombocytopenia or grade 3 thrombocytopenia with bleeding.

    Measured: The first administration cycle(21 days)

  2. Vital signs

    Number of cases with abnormal vital signs results

    Measured: Through study completion, 1 year

  3. Physical examination

    Number of cases with abnormal physical examination results

    Measured: Through study completion, 1 year

  4. Laboratory Examination

    Number of cases with abnormal laboratory examination results

    Measured: Through study completion, 1 year

  5. Electrocardiogram

    Number of cases with abnormal electrocardiogram results

    Measured: Through study completion, 1 year

  6. Echocardiography

    Number of cases with abnormal echocardiography results

    Measured: Through study completion, 1 year

  7. Adverse event

    Number of cases with all adverse medical events that occur after the subject receives the investigational drug assessed by CTCAE V5.0

    Measured: Through study completion, 1 year

Secondary outcomes (7)

  1. Pharmacokinetic

    Cmax

    Measured: Every cycle until 18 cycles (one cycle equals 3 weeks)

  2. Immunogenicity

    Presence of anti drug antibody (ADA)/Neutralizing antibodies (NAb)

    Measured: Every cycle until 18 cycles (one cycle equals 3 weeks)

  3. Objective response rate (ORR)

    Refer to the proportion of subjects defined as complete remission (CR) and partial remission (PR)

    Measured: Through study completion, 1 year

  4. Best Overall Response Rate(BORR)

    The proportion of subjects with complete response (CR) and partial response (PR) as the optimal ORR in tumor efficacy evaluation

    Measured: Through study completion, 1 year

  5. Progression-Free Survival(PFS)

    The time from the first administration to the occurrence of objective tumor progression or all cause death

    Measured: Through study completion, 1 year

  6. Duration of Response(DOR)

    DoR is defined as the time between the first assessment of objective remission of a tumor and death from any cause before the first assessment of Disease progression (PD) , reflecting the duration of ORR.

    Measured: Through study completion, 1 year

  7. Overall Survival(OS)

    The time from the date of first administration to the occurrence of death due to any cause. Subjects who were still alive at the time of analysis will use the date of their last contact as the deadline.

    Measured: Through study completion, 1 year

Timeline

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

  1. First posted18 Nov 2023
  2. Study start6 Mar 2024
  3. Primary completion2 Dec 2025
  4. Study completion17 Mar 2026

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06139536
Sponsor's protocol ID
BAT-4706-1308-001-CR
Status last verified
Mar 2026
First submitted
6 Nov 2023
Last updated
15 Oct 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 Injection and BAT1308 Injection in people with Advanced Solid Tumor, run by Bio-Thera Solutions at 3 sites 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 12 inclusion and 18 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 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 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: The first administration cycle(21 days)). The study lists 7 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 NCT06139536.

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.

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