Study of RO7515629 in Participants With HLA-G Positive Solid Tumors
Renal Cell Carcinoma, Non-small Cell Lung Cancer, Pancreatic Adenocarcinoma
About this trial
This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring HLA-G, Human leukocyte antigen G, Renal cell carcinoma, Non-small cell lung cancer, Pancreatic adenocarcinoma, Colorectal cancer, Epithelial ovarian cancer, Primary peritoneal cancer, Fallopian tube cancer, RO7515629, Tocilizumab
Eligibility Criteria
Inclusion Criteria: Unresectable and/or metastatic HLA-G-positive solid tumors, for which standard therapy does not exist, or has proven to be ineffective or intolerable The following tumor histologies will be permitted: Part 1: renal cell carcinoma (clear cell, papillary, chromophobe or unclassified), non-small cell lung cancer (squamous or non-squamous), pancreatic adenocarcinoma, epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer of the following subtype: serous high-grade carcinoma Part 2: renal cell carcinoma (clear cell, papillary, chromophobe or unclassified), non-small cell lung cancer (squamous or non-squamous), pancreatic adenocarcinoma, colorectal cancer, epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer of the following subtype: serous high-grade carcinoma Part 3: renal cell carcinoma with a clear-cell component; must have IMDC poor or intermediate risk disease and must have received no more than 3 prior systemic therapies in the advanced or metastatic setting (prior treatment must include an immune checkpoint inhibitor) Confirmed HLA-G tumor expression. Participants without archival tumor tissue available for testing must have a lesion amenable to biopsy. Radiologically measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 For part I only: non-measurable evaluable disease is acceptable. For participants in part 1 with epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer: participants without a measurable lesion must have evaluable disease and/or have CA-125 greater than 2 times the upper limit of normal (ULN). Life expectancy of at least 12 weeks Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Adequate hematological, liver, renal and pulmonary function Willingness to abide by protocol defined contraceptive requirements for the duration of the study. Exclusion Criteria: History or clinical evidence of Central Nervous System (CNS) metastases unless protocol specified criteria are met Leptomeningeal metastases Rapid disease progression including lesions that are a threat to vital organs or non-irradiated lesions 2cm or larger at critical sites where tumor swelling may pose a risk to critical anatomical structures Participants with another invasive malignancy in the last 2 years unless protocol specified criteria are met Uncontrolled hypertension Active interstitial lung disease (ILD), pneumonitis or a history of ILD/pneumonitis requiring treatment with steroids, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest Computed Tomography (CT) scan Participants with >10 bilateral pulmonary lesions (i.e., at least one lesion in each lung and more than 10 lung lesions in total) or pulmonary miliary metastatic pattern or pulmonary lymphangitic carcinomatosis History of pulmonary embolism within 3 months prior to study entry Significant cardiovascular disease Presence of active or uncontrolled infection or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to initiation of study treatment. Known hepatitis B or C (actively replicating) based on protocol specified criteria Known Human Immunodeficiency Virus (HIV) positivity Presence of an indwelling line or drain Active auto-immune disease that has required systemic therapy within the past 2 years unless protocol specified exceptions are met Major surgery within 28 days prior to first study treatment Last treatment with anti-cancer therapy or any investigational drug 28 days or less prior to the first study treatment Last dose of immunostimulating or immunosuppressive therapy 28 days or less prior to the first study treatment Regular dose of corticosteroids that exceeds prednisone 10 mg/day or equivalent within 28 days prior to first study treatment Prior treatment with T cell engaging or adoptive cell therapy Administration of a live, attenuated vaccine 28 days or less prior to first study treatment Contraindication or known hypersensitivity to any of the components of RO7515629 or tocilizumab or dexamethasone
Sites / Locations
- Sarah Cannon Research Institute at HealthONERecruiting
- Tennessee Oncology; Sarah Cannon Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Part I Single Participant Cohort RO7515629 Dose Escalation
Part II Multiple Participant Cohort RO7515629 Dose Escalation
Part III Multiple Participant Cohort RO7515629 Dose Expansion
Participants will receive a fixed dose of RO7515629 intravenously as a single agent on cycle 0 day -7 and 7 days later on cycle 1 day 1 followed by every three-week dosing frequency. Treatment may continue for up to 12 months maximum or until progression, loss of clinical benefit, intolerable toxicity, withdrawal from study treatment or death.
Participants will receive RO7515629 intravenously, as a single agent on cycle 0 day -7 and 7 days later on cycle 1 day 1 followed by every three-week dosing frequency. In case of toxicity, step up dosing (single or double) may be implemented. Treatment may continue for up to 12 months maximum or until progression, loss of clinical benefit, intolerable toxicity, withdrawal from study treatment or death.
Participants with selected solid tumors will receive a selected dose of RO7515629 intravenously as a single agent based on the recommended dose sequence for expansion (RDE) and dosing regimen selected from Part I and Part II. Treatment may continue for up to 12 months maximum or until progression, loss of clinical benefit, intolerable toxicity, withdrawal from study treatment or death.