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

NCT ID: NCT05769959

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-15
• Study Completion Date: 2024-03-19

Brief 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).

Conditions

Renal Cell Carcinoma; Non-small Cell Lung Cancer; Pancreatic Adenocarcinoma; Colorectal Cancer; Ovarian Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part I Single Participant Cohort RO7515629 Dose Escalation

Participants will receive a fixed dose of RO7515629 intravenously as a single agent on cycle 0 day -7 and 7 days later on cycle 1 day 1 followed by every three-week dosing frequency. Treatment may continue for up to 12 months maximum or until progression, loss of clinical benefit, intolerable toxicity, withdrawal from study treatment or death.

Group Type: EXPERIMENTAL

RO7515629

Intervention Type: DRUG

RO7515629 will be administered intravenously at a dose and schedule as specified for the respective study part and cohort.

tocilizumab

Intervention Type: DRUG

Tocilizumab will be used as rescue medication only. Tocilizumab will be administered as required for the management of cytokine release syndrome (CRS).

Part II Multiple Participant Cohort RO7515629 Dose Escalation

Participants will receive RO7515629 intravenously, as a single agent on cycle 0 day -7 and 7 days later on cycle 1 day 1 followed by every three-week dosing frequency. In case of toxicity, step up dosing (single or double) may be implemented. Treatment may continue for up to 12 months maximum or until progression, loss of clinical benefit, intolerable toxicity, withdrawal from study treatment or death.

Group Type: EXPERIMENTAL

RO7515629

Intervention Type: DRUG

RO7515629 will be administered intravenously at a dose and schedule as specified for the respective study part and cohort.

tocilizumab

Intervention Type: DRUG

Tocilizumab will be used as rescue medication only. Tocilizumab will be administered as required for the management of cytokine release syndrome (CRS).

Part III Multiple Participant Cohort RO7515629 Dose Expansion

Participants with selected solid tumors will receive a selected dose of RO7515629 intravenously as a single agent based on the recommended dose sequence for expansion (RDE) and dosing regimen selected from Part I and Part II. Treatment may continue for up to 12 months maximum or until progression, loss of clinical benefit, intolerable toxicity, withdrawal from study treatment or death.

Group Type: EXPERIMENTAL

RO7515629

Intervention Type: DRUG

RO7515629 will be administered intravenously at a dose and schedule as specified for the respective study part and cohort.

tocilizumab

Intervention Type: DRUG

Tocilizumab will be used as rescue medication only. Tocilizumab will be administered as required for the management of cytokine release syndrome (CRS).

Interventions

RO7515629

RO7515629 will be administered intravenously at a dose and schedule as specified for the respective study part and cohort.

Intervention Type: DRUG

tocilizumab

Tocilizumab will be used as rescue medication only. Tocilizumab will be administered as required for the management of cytokine release syndrome (CRS).

Intervention Type: DRUG

Other Intervention Names

Actemra, RoActemra

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

BP44068

Identifier Type: -

Identifier Source: org_study_id