None listed
Conditions
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Those with the appropriate protein expression profile (IFN gamma signature) confirmed through screening in the master protocol 2. Those with primary cancers of the hepatobiliary and pancreatic, triple-negative breast, small bowel-colon, bladder-ureter, kidney, skin, cervix, sarcoma, neuroendocrine cancer, and cancer of unknown primary site confirmed pathologically or cytologically 3. Those who are intolerant to standard therapy or have progressive disease 4. Those who are 19 years of age or older on the date of signing the consent form 5. Those with ECOG performance status 0-2 6. Those with an expected survival of > 8 weeks. 7. Those with adequate organ function as defined in the following items; •Absolute neutrophil count (ANC) = 1.0 x 109/L (= 1,000 per mm3) •Platelet count = 100 x 109/L (= 100,000 per mm3) •Serum bilirubin = 1.5 x institutional upper limit of normal (ULN). (Gilbert’s syndrome is an exception). •AST (SGOT)/ALT (SGPT) = 2.5 x institutional UNL (= 5x ULN in the presence of liver metastases) •24-h urine creatinine clearance or eGFR > 40 mL/min 8. For women, a negative pregnancy test or non-fertile women defined as follows: • Menopause (cessation of menstruation for more than 1 year without other medical reasons) based on medical history; • Patients who underwent hysterectomy or bilateral tubal ligation or bilateral oophorectomy; 9. Women of childbearing potential must agree to follow effective contraception (Appendix 1) during the trial period and for at least 6 months after the last dose of the trial drug, and must have a negative result in a urine or serum pregnancy test performed within 14 days prior to the first dose of the trial drug; 10. Presence of a measurable lesion on RECIST; 11. Patients who have not previously received anti-PD-1 or anti-PD-L1 therapy.
Exclusion criteria
Exclusion criteria: 1. The last dose of any anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, or targeted therapy (including tumor embolization and other investigational drugs) was administered less than 14 days before the first dose of the study drug (less than 28 days before the first dose of the study drug for subjects who had previously received monoclonal antibodies or biological therapy, and less than 42 days before the first dose of the study drug for subjects who had previously received nitrosourea or mitomycin C). 2. NCI CTCAE Grade =2 toxicity not resolved by prior chemotherapy, excluding alopecia, vitiligo, and laboratory values ??defined in the inclusion criteria a. Patients with neuropathy Grade =2 will be evaluated on a case-by-case basis after consultation with the investigator. b. Patients with irreversible toxicity not reasonably expected to be worsened by IP administration may be excluded only after consultation with the investigator. 3. Concurrent use of chemotherapy, IP, biologic agents, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer conditions (e.g., hormone replacement therapy) is permitted. 4. Radiation therapy or extensive radiotherapy to more than 30% of the bone marrow within 4 weeks of the first dose of the study drug 5. Major surgery (as defined by the investigator) within 28 days of the first dose of IP. Note: Local surgery to a single lesion for palliative purposes is permitted. 6. History of allogeneic organ transplantation. 7. Active or previous documented autoimmune or inflammatory disorder (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [except diverticulosis], systemic lupus erythematosus, sarcoid syndrome, or Wegener syndrome [including granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, and uveitis]). The following are exceptions to this criterion: a. Patients with vitiligo or alopecia b. Patients with stable hypothyroidism with hormone replacement (e.g., post-Hashimoto's syndrome) c. Chronic skin conditions that do not require systemic therapy d. Patients without active disease in the past 5 years may be included only after consultation with the study physician. e. Patients with celiac disease controlled by diet alone 8. Uncontrolled intercurrent diseases including but not limited to ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, cardiac arrhythmias, interstitial lung disease, significant chronic gastrointestinal conditions associated with diarrhea, or mental illness/social situations that limit compliance with study requirements, significantly increase the risk of developing AEs, or impair the patient's capacity to give written consent. 9. History of other primary malignant tumors, except for the following: a. Malignant tumors that have been treated with curative intent and have no known active disease within 3 years prior to the first administration of IP and are likely to have a low risk of recurrence b. Adequately treated nonmelanoma skin cancer or malignant melanoma without evidence of disease c. Adequately treated carcinoma in situ without evidence of disease 10. History of meningocele 11. Patients treated for brain metastases may participate if they demonstrate radiographic stability (defined as 2 brain scans obtained after treatment of brain metastases, obtained at least 4 weeks apart and showing no eviden
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comprehensive evaluation of CT or MRI results according to RECIST 1.1 criteria, and evaluation of laboratory tests/vital sign abnormalities, adverse reactions, etc. according to NCI CTCAE v5 | — |
Countries
Korea, Republic of
Contacts
Public Contacthye kyung Jang
National Cancer Center
Outcome results
None listed