solid tumor
Conditions
Interventions
DN1508052-01 combined with tririplizumab:SC/ivgtt
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older; 2. Part 1: Patients with histologically or cytologically confirmed advanced/metastases solid tumors that have progressed despite standard therapy or for which no standard therapy exists; Part 2: Patients with histologically or cytologically confirmed advanced solid tumors or locally advanced patients who are not suitable for radical treatment, and failed at least first-line standard therapy (patients with adjuvant therapy who have disease progression less than 6 months after the end of treatment can be considered as first-line treatment). Cohort 1: Head and neck squamous cell carcinoma (except from nasopharyngeal carcinoma): Progress/relapse after at least first-line platinum-based chemotherapy (adjuvant chemotherapy followed by surgery or radical radiotherapy, concurrent chemoradiotherapy for the primary tumor). Previous use of PD-1/PD-L1 immune checkpoint inhibitors. Cohort 2: Nasopharyngeal carcinoma: Progressed/relapsed after at least first-line platinum-based chemotherapy (e.g., platinum-based chemoradiotherapy or platinum-based chemoradiotherapy plus adjuvant chemotherapy). No restrictions on whether PD-1/PD-L1 immune checkpoint inhibitors have been used in the past. Cohort 3: Adenocarcinoma of the stomach or gastroesophageal junction: Progressed/relapsed after at least first-line therapy, except from confirmed HER2-positive gastric cancer (HER2 IHC3+; or FISH +). Previous use of PD-1/PD-L1 immune checkpoint inhibitors. Cohort 4: Upper tract urothelial carcinoma: Progressed/relapsed after at least first-line therapy. No restrictions on whether PD-1/PD-L1 immune checkpoint inhibitors have been used in the past. Cohort 5: Non-small cell lung cancer: Progressed/relapsed after at least first-line therapy. Previous use of PD-1/PD-L1 immune checkpoint inhibitors. Cohort 6: Small cell lung cancer: Progressed/relapsed after at least first-line therapy. No restrictions on whether PD-1/PD-L1 immune checkpoint inhibitors have been used in the past. Cohort 7: Esophageal cancer: Progressed/relapsed after at least first-line therapy. Previous use of PD-1/PD-L1 immune checkpoint inhibitors. Neuroendocrine tumor: includes G1, G2, and G3 NETs and neuroendocrine carcinomas. Progressed/relapsed after at least first-line therapy (including somatostatin analogs, angiogenesis inhibitors, mTOR inhibitors or chemotherapy, etc.). The use of somatostatin analogs (SSA) to control symptoms of functional tumor-secreting hormones is permitted, the dose must have been stable for 2 months prior to enrollment and is expected to remain stable during treatment. No previous use of PD-1/PD-L1 immune checkpoint inhibitors. Soft-tissue sarcoma: Progressed/relapsed after at least first-line therapy. Patients with undifferentiated pleomorphic sarcoma and acinar soft tissue sarcoma require prior use of PD-1/PD-L1 immune checkpoint inhibitors. Patients with other subtypes require no previous use of PD-1/PD-L1 immune checkpoint inhibitors. Malignant pleural mesothelioma: Progressed/relapsed after at least first-line therapy. Previous use of PD-1/PD-L1 immune checkpoint inhibitors. Cervical cancer: Progressed/relapsed after at least first-line therapy. No previous use of PD-1/PD-L1 immune checkpoint inhibitors. Triple-negative breast cancer: Progressed/relapsed after at least second-line therapy. No previous use of PD-1/PD-L1 immune checkpoint inhibitors. 3. ECOG performance score 0 or 1; 4. Life expectancy >= 3 months; 5. Patients
Exclusion criteria
Exclusion criteria: 1. Patients who have a history of another primary malignancy within 2 years before screening, with the exception of cured cutaneous squamous cell carcinoma, skin basal cell carcinoma, non-muscle-invasive bladder cancer, localized low-risk prostate cancer [stage 103 copies/mL) who are willing to continue antiviral therapy according to local standard treatment and whose liver function meets the inclusion criteria can be enrolled; Patients with a history of HCV infection but has negative PCR results for HCV RNA can be enrolled; (5) Patients received systemic corticosteroids (intravenous or broad-spectrum oral antibiotics for more than 1 week) within 28 days prior to the first administration of investigational product; 4. Patients with active or previous autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for patients with clinically stable autoimmune thyroid disease; 5. Patients who with an allo-transplant of any kind (including those with a xenograft heart valve); 6. Any significant ophthalmologic abnormality, including but not limited to the following: (1) Grade 2 or greater severity syndrome of dry eye; (2) Iritis. 7. Patients who have a history of definite neurological disorders that affected brain function activity, including epilepsy or dementia; 8. Patients with thrombotic or embolic events, such as cerebrovascular accident, uncontrolled deep vein thrombosis, pulmonary embolism, etc., within 6 months prior to the first dose of investigational product; Patients who is currently receiving thrombolytic or anticoagulant therapy such as warfarin, heparin, or similar drugs, or long-term nonsteroidal anti-inflammatory drug (NSAID) therapy; Prophylactic anticoagulation by open intravenous delivery systems is permitted, as long as the coagulation conditions required for enrollment are met within 7 days prior to initiation of investigational product; 9. Patients with clinically significant bleeding, or a clear bleeding tendency, such as gastroesophageal varices, gastrointestinal bleeding, hemorrhagic gastric ulcer, etc. within 3 months before the start of administration; patient with clinically significa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR); | — |
Countries
China
Contacts
Public ContactLin Shen
Outcome results
None listed