Study of RO7515629 in Participants With HLA-G Positive Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2027-01-29
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

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 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