Phase 1, open-label dose-escalation study to determine the MTD of INV-1120 and RP2D, and to assess the DLT of INV-1120 as a single agent or in the combination with pembrolizumab. The safety, tolerability, and PK of INV-1120 as a single agent or in the combination with pembrolizumab will be assessed in adult patients with advanced solid tumors.
Written informed consent, according to local guidelines, signed and dated by the patient prior to the performance of any study-specific procedures, sampling, or analyses;
Patient must be ≥18 years-of-age at the time of signature of the informed consent form (ICF);
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1;
Patients with histologically or cytologically confirmed advanced solid tumors which have progressed on or following standard therapy or for which no standard therapy exists;
History (≤5 years) or current evidence of cancer that is histologically distinct from the cancer under study, except for cervical carcinoma in situ, superficial non-invasive bladder tumors, or curatively treated Stage I non-melanoma skin cancer. Patients with hepatocellular carcinoma will be excluded from Phase 1b dose escalation;
Known serious allergy to investigational drug or excipients (microcrystalline cellulose);
History of severe autoimmune disease (including significant ongoing immune-related adverse events of prior immune-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at immunosuppressive doses (prednisone >10 mg/day or equivalent);
Known malignant central nervous system disease other than neurologically stable, treated brain metastases - defined as metastases having been treated by surgery, surgery plus radiotherapy or radiotherapy alone, with no evidence of progression or hemorrhage and off any systemic corticosteroids for at least 4 weeks prior to signing the consent;
Shenzhen Ionova Life Sciences Co., Ltd.
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator