Trial Title:
Assessment of Safety, Tolerability and Pharmacokinetics With BAT4706 and BAT1308 in Advanced Solid Tumors Patients
NCT ID:
NCT06139536
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Antineoplastic Agents, Immunological
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BAT4706 Injection
Description:
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.
Arm group label:
A/ Standard 3+3 1.0mg/kg of BAT4706 with 300mg of BAT1308
Arm group label:
B/ Standard 3+3 2.0mg/kg of BAT4706 with 300mg of BAT1308
Arm group label:
C/ Standard 3+3 3.0mg/kg of BAT4706 with 300mg of BAT1308
Arm group label:
D/ Standard 3+3 6.0mg/kg of BAT4706 with 300mg of BAT1308
Arm group label:
E/ Standard 3+3 10.0mg/kg of BAT4706 with 300mg of BAT1308
Other name:
Fc-glycosylated recombinant fully humanized anti-CTLA-4 monoclonal antibody injection
Intervention type:
Drug
Intervention name:
BAT1308 Injection
Description:
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.
Arm group label:
A/ Standard 3+3 1.0mg/kg of BAT4706 with 300mg of BAT1308
Arm group label:
B/ Standard 3+3 2.0mg/kg of BAT4706 with 300mg of BAT1308
Arm group label:
C/ Standard 3+3 3.0mg/kg of BAT4706 with 300mg of BAT1308
Arm group label:
D/ Standard 3+3 6.0mg/kg of BAT4706 with 300mg of BAT1308
Arm group label:
E/ Standard 3+3 10.0mg/kg of BAT4706 with 300mg of BAT1308
Other name:
Recombinant humanized anti PD-1 monoclonal antibody injection
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Voluntary signing of informed consent.
- Study population:
1. 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.
2. Dose expansion stage: Divided into 3 queues:
1. 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;
2. 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.
3. 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.
Exclusion Criteria:
- 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.
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Recruiting
Contact:
Last name:
Suxia Luo
Phone:
18638553211
Email:
luosxrm@163.com
Facility:
Name:
The First Affiliated Hospital of Henan University of Science and Technology
Address:
City:
Zhengzhou
Zip:
450052
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhiye Zhang
Facility:
Name:
Linyi Cancer Hospital
Address:
City:
Linyi
Zip:
276002
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhen Wang
Start date:
March 6, 2024
Completion date:
February 2026
Lead sponsor:
Agency:
Bio-Thera Solutions
Agency class:
Industry
Source:
Bio-Thera Solutions
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06139536
