Advanced Solid Tumors
Conditions
Interventions
Solid tumor patients group:None
Sponsors
Qingdao Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be enrolled in this study: 1.Histologically or cytologically confirmed advanced solid tumors, with no restriction on prior antitumor treatment regimens; 2.Age >=18 years; 3.Eastern Cooperative Oncology Group (ECOG) performance status score of 0–2; 4.Presence of >=1 measurable lesion according to RECIST v1.1 criteria; 5.Expected survival >=12 weeks; 6.Contraception: Women of childbearing potential or men with partners of childbearing potential must use effective contraception during treatment and for 6 months after the last dose; 7.Planned to receive Iparlizumab Tovorivenk monotherapy or combination regimens for antitumor treatment; 8.Voluntary participation with signed informed consent, good compliance, and ability to complete follow-up assessments.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will not be eligible for enrollment in this study: 1.History of or current autoimmune disease, interstitial lung disease, or other conditions requiring long-term use of systemic corticosteroids (>10 mg/day prednisone equivalent) or other immunosuppressive agents; 2.Prior Grade 3 or 4 immune-related adverse events (irAEs) from previous immunotherapy; 3.Known active infectious diseases, such as active hepatitis B or C or human immunodeficiency virus (HIV) infection. Active hepatitis B and C include patients with positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody who are receiving intravenous anti-infective treatment. Patients with hepatitis B or C receiving oral antiviral agents for suppressive therapy are permitted to enroll; 4.Known pregnant or lactating women; 5.Any other conditions that the investigator considers unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of Iparlizumab Tovorivenk, including incidence of all-grade TRAEs and Grade =3 TRAEs.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS);Objective Response Rate, ORR;Disease Control Rate, DCR;Overall Survival; | — |
Countries
China
Contacts
Public ContactCao Yufeng
Qingdao Traditional Chinese Medicine Hospital
Outcome results
None listed