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

clipboard-pencil

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).
user-3

Who can take part

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

INCLUSION 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. Confirmed HLA-G tumor expression.
  3. Radiologically measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  4. Life expectancy of at least 12 weeks
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  6. Adequate hematological, liver, renal and pulmonary function
  7. Willingness to abide by protocol defined contraceptive requirements for the duration of the study.

EXCLUSION CRITERIA

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 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
  8. Participants with pulmonary military metastatic pattern or pulmonary lymphangitic carcinomatosis
  9. History of pulmonary embolism within 3 months prior to study entry
  10. Significant cardiovascular disease
  11. 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.
  12. Known hepatitis B or C (actively replicating) based on protocol specified criteria
  13. Known Human Immunodeficiency Virus (HIV) positivity
  14. Presence of an indwelling line or drain
  15. Active auto-immune disease that has required systemic therapy within the past 2 years unless protocol specified exceptions are met
  16. Major surgery within 28 days prior to first study treatment
  17. Last treatment with anti-cancer therapy or any investigational drug 28 days or less prior to the first study treatment
  18. Last dose of immunostimulating or immunosuppressive therapy 28 days or less prior to the first study treatment
  19. Regular dose of corticosteroids that exceeds prednisone 10 mg/day or equivalent within 28 days prior to first study treatment
  20. Prior treatment with T cell engaging or adoptive cell therapy
  21. Administration of a live, attenuated vaccine 28 days or less prior to first study treatment
  22. Contraindication or known hypersensitivity to any of the components of RO7515629 or tocilizumab or dexamethasone

pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 888-662-6728 (U.S. and Canada)Email iconEmail Study Center

Study Details


Contition
Renal Cell Carcinoma,Non-small Cell Lung Cancer,Pancreatic Adenocarcinoma,Colorectal Cancer,Ovarian Neoplasms
Age (in years)
18+
Phase
PHASE1
Participants Needed
3
Est. Completion Date
Mar 19, 2024
Treatment Type
INTERVENTIONAL

Sponsor
Hoffmann-La Roche
ClinicalTrials.gov NCT Identifier
NCT05769959
Study Number
BP44068

Understanding Clinical Trials


Get answers to your questions about clinical trials.What is clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?