| Eligibility |
Inclusion Criteria:
1. Male or female aged 18 to 75 years (including upper and lower limit) at the time of
signing the informed consent form (ICF);
2. Subjects with locally advanced or metastatic solid tumors or lymphoma who have
histologically or cytologically confirmed inoperable disease at screening and have
failed from standard treatment,or cannot tolerate standard treatment and/or currently
have no effective standard treatment;
3. Patients must have at least 1 lesion that qualifies as a target lesion;
4. ECOG=1;
5. Life expectancy =3 months;
6. Adequate organ function;
7. Patients who have received any chemotherapy or anti-tumor monoclonal antibody drugs
within 4 weeks prior to the first dose of study drug (excluding mitomycin and
nitrosoureas within 6 weeks prior to the first dose of study drug); small molecule
targeted drugs within 2 weeks prior to the first dose of study drug; Chinese medicine
therapy (Chinese medicine therapy with clear anti-tumor indications in the package
insert )within 4 weeks prior to the first dose of study drug;
8. Patients, both females and males, of reproductive potential must agree to use adequate
contraception during and for 6 months after the last infusion of LTC004.
9. Understands and provides written informed consent and willing to follow the
requirements specified in protocol
Exclusion Criteria:
1. History of severe hypersensitivity reactions to other mAbs.
2. Untreated, unstable or uncontrolled central nervous system (CNS) metastases with
following exceptions:A. Clinically stable MRI scans (at least 2 consecutive scans
within prior 6 months including 1 scan within 28 days prior to screening) and no
progressive or uncontrolled neurologic symptoms or signs (e.g., seizures, headaches,
central nausea/emesis, progressive neurologic deficits, papilledema) for at least 4
weeks prior to the first study treatment;
3. Patients with uncontrolled pleural effusion, pericardial effusion or abdominal
effusion (requiring repeated drainage, more than one month or more frequently) as
judged by the investigator at screening;
4. Patients with untreated or clinically uncontrolled spinal cord compression (except for
those who have been treated and have stable symptoms and image for at least 4 weeks
before the first dose, and no evidence of cerebral edema, and no need for
glucocorticoid therapy);
5. Concurrent malignancy within 5 years prior to entry, except for adequately treated
cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell
carcinoma;
6. Moderate to severe dyspnea at rest, severe primary lung disease required for
continuous oxygen therapy, or clinically active interstitial lung disease (ILD) or
pneumonia due to advanced cancer or its complications; = Grade 3 interstitial
pneumonia during previous anti-tumor treatment;
7. History of moderate to severe dyspnea at rest due to advanced cancer or their
complications, severe primary lung disease, current need of continuous oxygen therapy,
or clinically active interstitial lung disease (ILD) or pneumonitis.
8. Severe infection within 4 weeks before the first dose, including but not limited to
bacteremia requiring hospitalization, severe pneumonia, etc.; active infection with
CTCAE = grade 2 requiring systemic antibiotics within 2 weeks before the first dose;
9. History of serious cardiovascular and cerebrovascular diseases, including but not
limited to: severe heart rhythm or conduction abnormalities, such as ventricular
arrhythmia requiring clinical intervention, II-III degree atrioventricular block,
etc.; acute coronary syndrome, congestive heart failure, aortic dissection, stroke or
other grade 3 and above cardiovascular and cerebrovascular events within 6 months
before the first dose; New York Heart Association (NYHA) functional classification =
II or left ventricular ejection fraction (LVEF) < 50% or clinically uncontrolled
hypertension (systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100
mmHg);
10. Patients who have any known liver disease, including chronic hepatitis B (HBsAg
positive and HBV DNA = ULN of local site and excluding hepatitis caused by drugs or
other reasons), hepatitis C, autoimmune hepatic disorders, primary biliary cirrhosis
or sclerosing cholangitis; Patients who have concurrent, serious, uncontrolled
infections or known infection with HIV, or have a diagnosed acquired immunodeficiency
syndrome (AIDS); or an uncontrolled autoimmune disease, or have undergone organ
transplant;
11. Syphilis positive patients at screening;
12. Patients with active autoimmune diseases (such as systemic lupus erythematosus,
rheumatoid arthritis, vasculitis, etc.) at screening, or have suffered from autoimmune
diseases that may relapse, except for patients with clinically stable autoimmune
thyroid disease;
13. History of immunodeficiency disease , including positive human immunodeficiency virus
(HIV) serum test;
14. Patients who have experienced bleeding symptoms of significant clinical significance
within 3 months before the first dose; Subjects who had a significant cough of blood
and hemoptysis of half a teaspoon (2.5 mL) or more per occasion within 4 weeks prior
to the first dose of study drug; arterial/venous thrombotic events such as
cerebrovascular accident, deep venous thrombosis, pulmonary embolism within 6 months
prior to the first dose; and those who were receiving anticoagulant therapy at
screening;
15. Patients who have received systemic immunosuppressive therapy (including but not
limited to glucocorticoids, cyclophosphamide, azathioprine, methotrexate, thalidomide,
etc.) within 2 weeks before the first dose;
16. Immunomodulatory drugs within 2 weeks (or 5 drug half-lives, whichever is longer)
before the first dose, including but not limited to thymosin, IL-2, IL-15, interferon,
etc.
17. Receiving non-thoracic radical radiotherapy > 30 Gy within 4 weeks before the first
dose, thoracic radiotherapy > 30 Gy within 24 weeks before the first dose, and
palliative radiotherapy = 30 Gy within 14 days before the first dose.
18. Received other unmarketed clinical study drugs or treatments within 4 weeks before the
first dose.
19. Use of live or attenuated vaccines within 4 weeks prior to the first dose, or
anticipated need for live or attenuated vaccines during the study.
20:Received major surgery within 4 weeks prior to the first dose (except for procedures for
diagnostic purposes), anticipated major surgery during the study (except for procedures for
diagnostic purposes), or diagnostic or less invasive surgery within 7 days prior to the
first dose (not in this range for needle biopsy).
21:Have not recovered from previous anti-tumor treatment, CTCAE 5.0 grade evaluation = 1
(alopecia and grade 2 neurotoxicity caused by chemotherapeutic drugs, as well as grade 2
hypothyroidism caused by anti-tumor treatment); 22:Patients who have previously received
allogeneic bone marrow/hematopoietic stem cell transplantation or solid organ
transplantation.
23:Pregnant and lactating women. 24:The subjects have a history of other serious systemic
diseases or any other reason (patients with mental illness, alcoholism, drug abuse or drug
abuse that may affect the compliance of the trial) should not participate in this trial as
judged by investigator.
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