About the study

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).

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Unresectable and/or metastatic HLA-G-positive solid tumors, for which standard therapy does not exist, or has proven to be ineffective or intolerable
2. The following tumor histologies will be permitted:
3. Part 1: renal cell carcinoma (clear cell, papillary or chromophobe subtypes), non-small cell lung cancer (squamous or non-squamous), pancreatic adenocarcinoma
4. Part 2: renal cell carcinoma (clear cell, papillary or chromophobe subtypes), non-small cell lung cancer (squamous or non-squamous), pancreatic adenocarcinoma, colorectal cancer
5. 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)
6. Confirmed HLA-G tumor expression. Participants without archival tumor tissue available for testing must have a lesion amenable to biopsy.
7. Radiologically measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
8. Life expectancy of at least 12 weeks
9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
10. Adequate hematological, liver, renal and pulmonary function
11. Willingness to abide by protocol defined contraceptive requirements for the duration of the study.

Exclusion criteria

1. History or clinical evidence of Central Nervous System (CNS) metastases unless protocol specified criteria are met
2. Leptomeningeal metastases
3. 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
4. Participants with another invasive malignancy in the last 2 years unless protocol specified criteria are met
5. Uncontrolled hypertension
6. 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
7. 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
8. Significant cardiovascular disease
9. 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.
10. Known hepatitis B or C (actively replicating) based on protocol specified criteria
11. Known Human Immunodeficiency Virus (HIV) positivity
12. Presence of an indwelling line or drain
13. Active auto-immune disease that has required systemic therapy within the past 2 years unless protocol specified exceptions are met
14. Major surgery within 28 days prior to first study treatment
15. Last treatment with anti-cancer therapy or any investigational drug 28 days or less prior to the first study treatment
16. Last dose of immunostimulating or immunosuppressive therapy 28 days or less prior to the first study treatment
17. Regular dose of corticosteroids that exceeds prednisone 10 mg/day or equivalent within 28 days prior to first study treatment
18. Prior treatment with T cell engaging or adoptive cell therapy
19. Administration of a live, attenuated vaccine 28 days or less prior to first study treatment
20. Contraindication or known hypersensitivity to any of the components of RO7515629 or tocilizumab or dexamethasone

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.