Trial Title:
Study in Patients With Advanced Solid Tumors to Evaluate the Safety of FTL008.16
NCT ID:
NCT06410131
Condition:
Solid Tumors
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Solid Tumors
Sound Biopharmaceuticals
FTL008.16
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
FTL008.16
Description:
IV infusion every 2 weeks
Arm group label:
Arm 1 Part 1 Dose Escalation
Arm group label:
Arm 1 Part 2 Dose Expansion
Summary:
This is an open, multi-center, multi-cohort phase I clinical study designed to evaluate
safety, tolerability, pharmacokinetics and initial efficacy of FTL008.16 in patients with
advanced and metastatic solid tumors.
Detailed description:
This study is divided into two phases: Part 1(dose escalation of FTL008.16) and Part
2(dose extension of FTL008.16), which is intended to include about 40 to 68 subjects.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntarily participate in the experiment and sign a written informed consent, with
good compliance, and can follow the protocol visit plan and other research
procedures.
2. Age ≥18 years and ≤75 years at the time of signing the informed consent, both male
and female.
3. Expected survival ≥ 3 months.
4. Histologically or cytologically confirmed advanced solid tumors; The enrollment
should focus on subjects with multiple solid tumor types/histologies likely to
express 5T4 antigen, including but not limited to non-small cell lung cancer
(NSCLC), stomach cancer, esophageal cancer, colorectal cancer, pancreatic cancer,
head cancer, cervical squamous cell carcinoma, renal cell carcinoma, urothelial
carcinoma, prostate cancer, breast cancer, ovary cancer, cervical cancer,
endometrial cancer or malignant pleural mesothelioma.
5. Patients with advanced recurrence and metastasis of solid tumors with disease
progression after standard treatment or intolerance to standard treatment or no
standard treatment (definitions of standard treatment and recurrence refer to the
latest CSCO guidelines or other authoritative diagnosis and treatment guidelines at
home and abroad).
6. According to RECIST 1.1 solid tumor efficacy evaluation criteria, the patient had at
least one lesion that could be measured or evaluated on imaging (CT, MRT); Patients
enrolled in the extended study should have at least one measurable lesion; (Note:
Tumor lesions that have previously received local treatment (such as radiotherapy,
ablation, vascular intervention, etc.) will not be considered measurable unless
there is sufficient evidence to demonstrate clear imaging progression of the lesion
after local treatment).
7. Eastern Cancer Collaboration (ECOG) Physical fitness score of 0 or 1.
8. The patient must provide the required tumor tissue specimen (fresh tumor tissue or
archived tumor tissue specimen).
9. The results of laboratory examination during the screening period indicate that the
subject has good organ function;
10. If sexually active: females of childbearing potential must practice a medically
effective methods of contraception during study participation and for at least 6
months after last dose of study drug.
11. If sexually active: men who are sexually active with females of child-bearing
potential must agree to use highly effective methods of contraception during study
participation and for at least 6 months after the last dose of study drug..
Exclusion Criteria:
1. History of hypersensitivity or idiosyncrasy to the excipients of the study drug or
to any monoclonal antibody.
2. A history of malignancies other than the disease under study within the previous 5
years, with the exception of malignancies that have been cured after treatment and
have no risk of recurrence (including but not limited to adequately treated thyroid
cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or breast
ductal carcinoma in situ treated with radical surgery).
3. Systematic treatment with anti-tumor drugs (including chemotherapy, targeted
therapy, antibody therapy, immunotherapy, endocrine therapy, etc.) was received
within 4 weeks before the initial study.
4. Patients who have previously received cell immunotherapy (CAR-T).
5. Prior treatment with any anti-CD137/anti-5T4 antibody or drug (single agent or
combination).
6. Adverse reactions caused by previous treatment did not recover to CTCAE (version
5.0) grade 1 or below (Alopecia, neurotoxicity returned to grade 2 or below, adverse
reactions that the investigators judged were not a safety risk could be included);
7. Previously received allogeneic hematopoietic stem cell transplantation or solid
organ transplantation;
8. Active primary or metastatic tumors of the central nervous system (except in
patients who have previously been treated and have discontinued treatment 4 weeks
prior to the first study drug administration, symptomless patients who do not
require long-term glucocorticoid therapy), seizures, spinal cord compression,
meningeal metastases, or carcinomatous meningitis.
9. Have or have suspected active autoimmune diseases, including but not limited to
systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease,
etc., but the following conditions can be included: Type 1 diabetes that can be
controlled by alternative therapy alone, skin diseases that do not require systemic
treatment (e.g. Psoriasis, vitiligo).
10. Suffering from pleural effusion, ascites or pericardial effusion that cannot be
controlled by clinical symptoms or treatment.
11. Severe cardiovascular and cerebrovascular diseases, such as resting QTc interval
≥470ms (corrected QT interval, according to the Fridericia formula); Uncontrolled or
poorly controlled hypertension (systolic more than 160mmHg or diastolic more than
100mmHg) or pulmonary hypertension; Unstable angina pectoris or myocardial
infarction, coronary artery bypass grafting or stenting within 6 months prior to
study administration; Chronic heart failure with heart function ≥2 (NYHA rating);
Degree II and above heart block; Left ventricular ejection fraction (LVEF) less than
50%; Study cerebrovascular accident (CVA) or transient ischemic attack (TIA) within
6 months prior to medication.
12. History of pulmonary disease: interstitial pneumonia, obstructive pulmonary disease
(requiring steroid treatment with a prednisone equivalent dose of more than 10mg/
day) or symptomatic bronchospasm.
13. Active tuberculosis (TB) is known to exist. Subjects suspected of active TB should
be examined for chest X-rays, sputum, and clinical signs and symptoms.
14. An active infection requiring intravenous anti-infective treatment, or severe
unhealed wounds or ulcers, occurs within 14 days prior to the first dose.
15. Positive human immunodeficiency virus (HIV) antibody test result, or active syphilis
infection (i.e., positive treponema pallidum antibody and non-treponema pallidum
antibody titer test result).
16. Autoimmune liver disease and decompensated cirrhosis; People with active hepatitis B
virus or hepatitis C virus.
17. Systemic immunosuppressive therapy is required if received within 14 days before the
first dose or during the trial. However, the following conditions were allowed: in
the absence of active autoimmune disease, patients were allowed to use nasal spray,
inhalation, or topical corticosteroid drugs, or other corticosteroid drugs with a
prednisone equivalent dose ≤10 mg/ day.
18. Receive live vaccination within 4 weeks prior to the initial study administration.
19. Major surgical operations (including primary tumor operations, craniotomy,
thoracotomy or laparotomy, etc., excluding vascular access establishment operations)
were performed within 4 weeks prior to the first study of drug use.
20. Those who have a history of psychotropic drug abuse and cannot quit or have a
history of mental disorders.
21. Pregnant or lactating women.
22. There are other severe, acute, or chronic medical or psychiatric disorders or
laboratory abnormalities, as determined by the investigator, that may increase the
risks associated with participation in the study or that may interfere with the
interpretation of the study findings.
23. Patients who have participated in or are being treated in other clinical trials for
any other drug within 28 days prior to the first dose and plan to receive other
anticancer therapy or other investigational drug during the study period.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Contact:
Last name:
Ning Li, MD
Investigator:
Last name:
Ning Li, MD
Email:
Principal Investigator
Start date:
June 2024
Completion date:
May 2027
Lead sponsor:
Agency:
Sound Biopharmaceuticals Ltd.
Agency class:
Industry
Source:
Sound Biopharmaceuticals Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06410131
