Overview
This study is a phase I study to evaluate the safety and tolerability of TQB2858 injection in patients with advanced malignancy.
Eligibility
Inclusion Criteria:
- Patients with advanced malignancies diagnosed histologically and/or cytologically, where standard treatment has failed or there is no effective treatment;
- Age: 18-75 years old;
- ECOG score: 0 ~ 1;
- Expected survival of more than 3 months;
- The main organs are functioning normally;
- Women of childbearing age must be negative for serum or urine HCG within 7 days prior to study enrollment and must be non-lactating;Patients should agree to use contraception during the study period and for 6 months after the study period.
- Patients voluntarily joined the study and signed the informed consent, showing good compliance.
Exclusion Criteria:
-Complicated disease and history: A) Has developed other malignant tumors within 2 years or
is currently suffering from the same tumor; B) unmitigated toxic reactions above CTC AE
grade 1 due to any prior treatment, excluding hair loss and peripheral sensory nerve
disorders; C) received major surgical treatment or significant traumatic injury (excluding
needle biopsy) within 28 days prior to the commencement of study treatment; D) Long-term
unhealed wounds or fractures; E) The occurrence of arterial/venous thrombosis events within
6 months, such as cerebrovascular accidents (including temporary ischemic attack, cerebral
hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; F) People
with a history of psychotropic substance abuse and inability to quit or with mental
disorders; G) subjects with any severe and/or uncontrolled disease;"
-Tumor-related symptoms and treatment: A) had undergone surgery, chemotherapy, radiation or
other anticancer therapy within 4 weeks prior to the start of study treatment (washout
period was calculated from the end of the last treatment); B) Chinese patent drugs with
anti-tumor indications specified in the NMPA approved drug specifications (including
compound cantharide capsule, Kangai injection, Kanglaite capsule/injection, Aidi injection,
Brucea oil injection/capsule, Xiaoaoping tablet/injection, Huabenin capsule, etc.) were
received within 2 weeks before the start of the study; C) previously received immunodouble
antibody therapy targeting the same target of TQB2858 injection; D) uncontrolled pleural
effusion, pericardial effusion, or ascites that still require repeated drainage (as
determined by the investigator); E) Patients with brain metastases whose symptoms
stabilized less than 4 weeks after discontinuation of dehydrants and steroids;"
-Research Treatment Related: A) a history of live attenuated vaccine vaccination within 28
days prior to the study treatment initiation or a planned live attenuated vaccine
vaccination during the study period; B) Previous history of severe allergy to
macromolecular drugs or known components of TQB2858 injection; C) Study the occurrence of
active autoimmune disease requiring systemic treatment (e.g., use of palliative drugs,
corticosteroids, or immunosuppressants) within 2 years prior to treatment
initiation.Alternative therapies (such as thyroxine, insulin, or physiological
corticosteroids for adrenal or pituitary insufficiency) are not considered systemic; D)
have been diagnosed with immunodeficiency or are receiving systemic glucocorticoid therapy
or any other form of immunosuppressive therapy.(dose of >10mg/ day prednisone or other
equivalent efficacy hormone), and continued to use within 2 weeks of the first
administration;" Participants had participated in other antitumor drug clinical trials in
the previous 4 weeks;
-Subject who, in the Investigator's judgment, has a concomitant disease that seriously
endangers the subject's safety or affects the completion of the study, or is considered
unsuitable for inclusion for other reasons.