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Study of RO7515629 in Participants With HLA-G Positive Solid Tumors
- Colorectal Cancer (CRC)
- Non-Small Cell Lung Cancer
- Pancreatic Adenocarcinoma
- Renal Cell Carcinoma
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
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 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.
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
- 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