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;
Sequential
INV-1120
DrugINV-1120 is an investigational selective and potent small molecule indicated for the treatment of solid malignancies including, but not limited to colorectal, breast, pancreatic, lung and liver cancers.
Pembrolizumab
Combination productPembrolizumab will be administered as a dose of 200 mg on Day 1 of each 3-week treatment cycle.
Phase 1a: Determine DLTs and RP2Ds in INV-1120
To evaluate dose limiting toxicities (DLTs) of INV-1120 in patients with advanced cancer and to establish a recommended Phase 2 dose (RP2D)
Phase 1b: Determine RP2D and DLTs of the combination of INV-1120 and pembrolizumab
To determine RP2D, and to assess DLT of the combination of INV-1120 and pembrolizumab administered to adult patients with advanced solid tumors.
Phase 1a: Determine the PK using AUC of INV-1120
To determine the pharmacokinetics (PK) using AUC of INV-1120 after a single dose and at steady state after multiple doses
Phase 1b: Determine the PK using AUC of INV-1120
To determine the pharmacokinetics (PK) using AUC of INV-1120 after a single dose and at steady state after multiple doses in combination with pembrolizumab
Phase 1a: Determine the PK using Cmax of INV-1120
To determine the pharmacokinetics (PK) using Cmax of INV-1120 after a single dose and at steady state after multiple doses
Phase 1b: Determine the PK using Cmax of INV-1120
To determine the pharmacokinetics (PK) using Cmax of INV-1120 after a single dose and at steady state after multiple doses in combination with pembrolizumab
Phase 1a: Characterize investigator defined ORR using iRECIST
To characterize investigator defined ORR using iRECIST
Phase 1a: Characterize investigator defined PFS using iRECIST
To characterize investigator defined PFS using iRECIST
Phase 1a: Characterize investigator defined DOR using iRECIST
To characterize investigator defined DOR using iRECIST
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Shenzhen Ionova Life Sciences Co., Ltd.
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
