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Study of RO7515629 in Participants With HLA-G Positive Solid Tumors
- Cancer
- Colorectal Cancer (CRC)
- Lung Cancer
- Non-Small Cell Lung Cancer (NSCLC)
- Pancreatic Cancer
- Pancreatic Adenocarcinoma
- Tumor
- Neoplasms
- Ovarian Neoplasms
- Renal Cell Cancer (RCC)
- Renal Cell Carcinoma
Please note that the recruitment status of the trial at your site may differ.
Trial Status:
Recruiting
This trial runs in
Countries
- United States
Trial Identifier:
NCT05769959 BP44068
Trial Summary
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).
Hoffmann-La Roche
Sponsor
Phase 1/Phase 2
Phase
NCT05769959,BP44068
Trial Identifier
RO7515629, tocilizumab
Treatments
Renal Cell Carcinoma, Non-small Cell Lung Cancer, Pancreatic Adenocarcinoma, Colorectal Cancer, Ovarian Neoplasms
Condition
Official Title
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
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
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 I and Part II: 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 III: 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 I 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) within 2 weeks prior to first dose of study drug.
- 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 central cavitation or tumor(s) shown to be invading or abutting major blood vessels by imaging or the Investigator determines the tumor(s) is likely to invade major blood vessels and cause fatal bleeding
- Participants with pulmonary military 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
For the latest version of this information please go to www.forpatients.roche.com