Locally Advanced or Metastatic Solid Tumors
Conditions
Interventions
Dose-escalation group:THZ0106
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Patients who voluntarily sign a written informed consent form (ICF). 2) Male or female patients aged =18 years at the time of signing the ICF. 3) Target population: Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors for whom standard of care has failed (progressive disease after treatment or treatment intolerance) or no standard of care regimen available or for whom the standard of care is not applicable at this stage. 4) Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1. 5) Expected survival =3 months. 6) Adverse reactions caused by previous treatments have recovered to NCI CTCAE v5.0 grade 1 and below before screening (except for alopecia and grade 2 neurotoxicity caused by chemotherapy drugs). 7) Adequate normal bone marrow, hepatic and renal function. 8) Presence of at least one measurable tumor lesion according to RECIST v1.1 criteria. A lesion that has received radiotherapy in the past is only considered a measurable lesion if the lesion has clearly progressed. 9) Agree to use reliable contraceptive methods as required by the study protocol.
Exclusion criteria
Exclusion criteria: 1) Patients who have received any anti-tumor treatment within 4 weeks before the first investigational product administration. 2) Patients who have received systemic corticosteroid therapy (prednisone >10 mg/d or equivalent dose of similar drugs) or any other immunosuppressive therapy within 14 days before the first investigational product administration. 3) Patients who have risk factors for intestinal obstruction or intestinal perforation. 4) Patients who have CNS metastasis with clinical symptoms or other evidence that CNS metastasis has not been controlled. 5) Patients with a history of leptomeningeal disease. 6) Patients who have active or have had autoimmune disease or immunodeficiency. 7) Patients who are known to be allergic to THZ0106 or any of its excipients, or have a history of hypersensitivity to other monoclonal or bispecific antibody treatment. 8) Patients who have received live vaccine, attenuated live vaccine or equivalent vaccine within 4 weeks before the first administration of THZ0106. 9) Patients who had an active infection requiring systemic treatment within 2 weeks before the first administration of THZ0106. 10) Patients with active cardiovascular diseases. 11) Uncontrollable tumor-related pain. 12) Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 13) Patients with active hepatitis B, hepatitis C or positive HIV screening. 14) Patients who have previously received TIGIT immune checkpoint antibody therapy. 15) Patients with any situation that does not conform to their best benefit as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AE;Physical examination;Vital signs;Laboratory tests;ECOG score;12-lead ECG;Dose limited toxicity ; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK;ADA;ORR;DOR;DCR;PFS;OS; | — |
Countries
China
Contacts
Public ContactZhou Caicun
Shanghai Pulmonary Hospital
Outcome results
None listed