Patient population
NSCLC, ovarian cancer, SCLC, melanoma, CRC, adenocarcinoma of esophago-gastric conjunction, lung cancer, HCC, interstitial lung disease, tumors, autoimmune disease, NPC, gastric cancer
OVARIAN CANCER, SCLC, MELANOMA, FALLOPIAN TUBE CANCER, BREAST CANCER, UROTHELIAL CARCINOMA, SOLID TUMORS, KIDNEY CANCER, SOLID TUMOR, LUNG CANCER, ENDOMETRIAL CARCINOMA, NSCLC, ONCOLOGY, TUMORS, DISEASES, ESOPHAGEAL CARCINOMA, CHOLANGIOCARCINOMA
Patients meeting the following key inclusion criteria were enrolled into phase I: (1) aged ≥ 18 years; (2) pathologically confirmed diagnosis of advanced solid tumor with failed on or with no standard antitumor therapy; (3) at least one measurable lesion according to RECIST v1.1; (4) with an Eastern Cooperative Oncology Group performance status of 0 or 1 and a life expectancy of greater than 3 months. The key exclusion criteria were as follows: (1) previous or active autoimmune disease, interstitial lung disease, or other diseases requiring long-term use of systemic corticosteroids (> 10 mg/day prednisone) or other immunosuppressive drugs; (2) grade 3 or 4 irAEs related to prior immunotherapy; (3) prior treatment with anti-CTLA-4 and anti-PD-(L)1 combination. Eligible patients received QL1706 as a single agent monotherapy.In phase Ib (indication expansion), the types of tumors were specified for eligible patients, including pathologically confirmed metastatic or recurrent CC, ovarian cancer, fallopian tube cancer, endometrial carcinoma, NPC, gastric cancer, adenocarcinoma of esophago-gastric conjunction, esophageal carcinoma, and metastatic or recurrent solid tumors, including lung cancer (NSCLC, SCLC), HCC, cholangiocarcinoma, breast cancer, CRC, urothelial carcinoma, melanoma, and kidney cancer.The major differences of phase Ib compared to phase I were that in phase Ib, the patients were required to have at least one measurable lesion according to the Response Evaluation Criteria In Solid Tumours (RECIST) v1.1, the absolute platelet count was set to > 75 × 10