Kidney Cancer Clinical Trial

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

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).

View Eligibility Criteria

Eligibility 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
Confirmed HLA-G tumor expression.
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 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

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

3

Study ID:

NCT05769959

Recruitment Status:

Terminated

Sponsor:

Hoffmann-La Roche

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There are 2 Locations for this study

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Sarah Cannon Research Institute at HealthONE
Denver Colorado, 80218, United States
SCRI Oncology Partners
Nashville Tennessee, 37203, United States

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

3

Study ID:

NCT05769959

Recruitment Status:

Terminated

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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