Study of RO7515629 in Participants With HLA-G Positive Solid Tumors
- Colorectal Cancer (CRC)
- Non-Small Cell Lung Cancer
- Pancreatic Adenocarcinoma
- Renal Cell Carcinoma
- United States
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, immune response and preliminary anti-tumor activity of RO7515629 alone in participants with advanced or metastatic solid tumors expressing human leukocyte antigen G (HLA-G).
An Open-Label, Multicenter, Phase 1 Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of RO7515629 in Participants With Unresectable and/or Metastatic HLA-G Positive Solid Tumors
- 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 or chromophobe subtypes), non-small cell lung cancer (squamous or non-squamous), pancreatic adenocarcinoma
- Part 2: renal cell carcinoma (clear cell, papillary or chromophobe subtypes), non-small cell lung cancer (squamous or non-squamous), pancreatic adenocarcinoma, colorectal cancer
- 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
- 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.
- 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
- 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
For the latest version of this information please go to www.forpatients.roche.com