Patients
large-cell lung cancer, tumor, high-grade liposarcomas, undifferentiated pleomorphic sarcoma, head and neck squamous cell carcinoma, toxicities, sarcoma, small-cell lung cancer
TUMOR, CANCER, SOLID TUMORS, SARCOMA, MALIGNANT PLEURAL MESOTHELIOMA, ONCOLOGY, UNDIFFERENTIATED PLEOMORPHIC SARCOMA, ESOPHAGEAL CARCINOMA, GASTRIC CANCER
Part 1 included patients with histologically or cytologically confirmed advanced or metastatic (unresectable), relapsed, or refractory solid tumors who had failed/did not tolerate standard therapy or for whom there was no available standard treatment. Selected tumor types in part 1 phase 1b included the following: arm 1—soft tissue sarcoma, including, but not limited to, undifferentiated pleomorphic sarcoma and dedifferentiated or other high-grade liposarcomas; arm 2—malignant pleural mesothelioma; arms 3 and 4—bladder cancer, Merkel cell carcinoma, gastric cancer, esophageal carcinoma, small-cell lung cancer, large-cell lung cancer, head and neck squamous cell carcinoma, or cutaneous squamous cell carcinoma; and any solid tumors with microsatellite instability-high or deficient mismatch repair (MSI-H/dMMR). Patients in part 2 had mCRC and had progressed or intolerable toxicities after least two lines of standard-of-care therapies (i.e., fluorouracil, oxaliplatin, and irinotecan-based chemotherapy). Patients with known MSI-H/dMMR and patients who had previously received regorafenib, fruquintinib or other VEGFR tyrosine kinase inhibitors were excluded from part 2. All patients had an Eastern Cooperative Oncology Group performance status of 0 or 1 and a life expectancy ≥3 months. Patients who previously received any targeted T-Cell co-regulated proteins (immune checkpoint proteins) antibody/medicine (including PD-1 and PD-L1) were excluded. Detailed inclusion and exclusion criteria are provided in the 