Study Of RO7515629 In Participants With HLA-G Positive Solid Tumors

Study Overview

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

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).

N/A

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

DRUG: RO7515629
DRUG: tocilizumab

BP44068

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-03-03	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-07-08
First Submitted that Met QC Criteria 2023-03-03	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-07-09
First Posted (ACTUAL) 2023-03-15	Results First Posted N/A	Last Verified 2024-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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,	DRUG: RO7515629 RO7515629 will be administered intravenously at a dose and schedule as specified for the respective study part and cohort. DRUG: tocilizumab Tocilizumab will be used as rescue medication only. Tocilizumab will be administered as required for the management of cytokine release syndrome (CRS).
EXPERIMENTAL: 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 ma	DRUG: RO7515629 RO7515629 will be administered intravenously at a dose and schedule as specified for the respective study part and cohort. DRUG: tocilizumab Tocilizumab will be used as rescue medication only. Tocilizumab will be administered as required for the management of cytokine release syndrome (CRS).
EXPERIMENTAL: 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	DRUG: RO7515629 RO7515629 will be administered intravenously at a dose and schedule as specified for the respective study part and cohort. DRUG: tocilizumab Tocilizumab will be used as rescue medication only. Tocilizumab will be administered as required for the management of cytokine release syndrome (CRS).

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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,

DRUG: RO7515629

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

DRUG: tocilizumab

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

EXPERIMENTAL: 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 ma

DRUG: RO7515629

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

DRUG: tocilizumab

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

EXPERIMENTAL: 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

DRUG: RO7515629

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

DRUG: tocilizumab

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

Primary Outcome Measures	Measure Description	Time Frame
Part 1, 2, 3: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		Up to 15 months
Part 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs)		From start of study treatment (cycle 0 day -7 or cycle 0 day -14) until two weeks after second or third RO7515629 infusion (cycle 1 day 1) for a total DLT window of up to 28 days.

Secondary Outcome Measures	Measure Description	Time Frame
Part 1, 2, 3: Pharmacokinetic Analysis: Maximum Serum Concentration (Cmax) of RO7515629		Up to 13 months
Part 1, 2, 3: Pharmacokinetic Analysis: Time of Maximum Serum Concentration (Tmax) of RO7515629		Up to 13 months
Part 1, 2, 3: Pharmacokinetic Analysis: Minimum Serum Concentration (Cmin) of RO7515629		Up to 13 months
Parts 1, 2, 3: Pharmacokinetic Analysis: Clearance (CL) of RO7515629		Up to 13 months
Part 1, 2, 3: Pharmacokinetic Analysis: Volume of Distribution at Steady State (Vss) of RO7515629		Up to 13 months
Part 1, 2, 3: Pharmacokinetic Analysis: Area Under The Curve (AUC) of RO7515629		Up to 13 months
Part 1, 2, 3: Number of Participants With RO7515629 Anti-drug Antibodies (ADAs)		Up to 13 months
Part 1, 2, 3: Objective Response Rate (ORR)		Up to approximately 18 months
Part 1, 2, 3: Disease Control Rate (DCR)		Up to approximately 18 months
Part 1, 2, 3: Duration of Response (DoR)		Up to approximately 18 months
Part 1, 2, 3: Progression Free Survival (PFS)		Up to approximately 18 months
Part 1, 2, 3: Overall survival (OS)	Defined as the time from first dose of study treatment to time of death.	Up to approximately 18 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Clinical Trials, Hoffmann-La Roche

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record