- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05769959
Study of RO7515629 in Participants With HLA-G Positive Solid Tumors
February 14, 2024 updated by: Hoffmann-La Roche
An Open-Label, Multicenter, Phase 1 Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of RO7515629 in Participants With Unresectable and/or Metastatic 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).
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
150
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Reference Study ID Number: BP44068 https://forpatients.roche.com/
- Phone Number: 888-662-6728 (U.S. and Canada)
- Email: global-roche-genentech-trials@gene.com
Study Locations
-
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Colorado
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Denver, Colorado, United States, 80218
- Sarah Cannon Research Institute at HealthONE
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Tennessee
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Nashville, Tennessee, United States, 37203
- Tennessee Oncology; Sarah Cannon Research Institute
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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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 I and Part II: renal cell carcinoma (clear cell, papillary, chromophobe or unclassified), non-small cell lung cancer (squamous or non-squamous), pancreatic adenocarcinoma, colorectal cancer, epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer of the following subtype: serous high-grade carcinoma
- Part III: 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
- For Part I only: non-measurable evaluable disease is acceptable.
- For participants in Part I with epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer: participants without a measurable lesion must have evaluable disease and/or have CA-125 greater than 2 times the upper limit of normal (ULN) within 2 weeks prior to first dose of study drug.
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
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, loss of clinical benefit, intolerable toxicity, withdrawal from study treatment or death.
|
RO7515629 will be administered intravenously at a dose and schedule as specified for the respective study part and cohort.
Tocilizumab will be used as rescue medication only.
Tocilizumab will be administered as required for the management of cytokine release syndrome (CRS).
Other Names:
|
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 may continue for up to 12 months maximum or until progression, loss of clinical benefit, intolerable toxicity, withdrawal from study treatment or death.
|
RO7515629 will be administered intravenously at a dose and schedule as specified for the respective study part and cohort.
Tocilizumab will be used as rescue medication only.
Tocilizumab will be administered as required for the management of cytokine release syndrome (CRS).
Other Names:
|
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 to 12 months maximum or until progression, loss of clinical benefit, intolerable toxicity, withdrawal from study treatment or death.
|
RO7515629 will be administered intravenously at a dose and schedule as specified for the respective study part and cohort.
Tocilizumab will be used as rescue medication only.
Tocilizumab will be administered as required for the management of cytokine release syndrome (CRS).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Part 1, 2, 3: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to 15 months
|
Up to 15 months
|
Part 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs)
Time Frame: 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.
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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
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part 1, 2, 3: Pharmacokinetic Analysis: Maximum Serum Concentration (Cmax) of RO7515629
Time Frame: Up to 13 months
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Up to 13 months
|
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Part 1, 2, 3: Pharmacokinetic Analysis: Time of Maximum Serum Concentration (Tmax) of RO7515629
Time Frame: Up to 13 months
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Up to 13 months
|
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Part 1, 2, 3: Pharmacokinetic Analysis: Minimum Serum Concentration (Cmin) of RO7515629
Time Frame: Up to 13 months
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Up to 13 months
|
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Parts 1, 2, 3: Pharmacokinetic Analysis: Clearance (CL) of RO7515629
Time Frame: Up to 13 months
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Up to 13 months
|
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Part 1, 2, 3: Pharmacokinetic Analysis: Volume of Distribution at Steady State (Vss) of RO7515629
Time Frame: Up to 13 months
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Up to 13 months
|
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Part 1, 2, 3: Pharmacokinetic Analysis: Area Under The Curve (AUC) of RO7515629
Time Frame: Up to 13 months
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Up to 13 months
|
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Part 1, 2, 3: Number of Participants With RO7515629 Anti-drug Antibodies (ADAs)
Time Frame: Up to 13 months
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Up to 13 months
|
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Part 1, 2, 3: Objective Response Rate (ORR)
Time Frame: Up to approximately 18 months
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Up to approximately 18 months
|
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Part 1, 2, 3: Disease Control Rate (DCR)
Time Frame: Up to approximately 18 months
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Up to approximately 18 months
|
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Part 1, 2, 3: Duration of Response (DoR)
Time Frame: Up to approximately 18 months
|
Up to approximately 18 months
|
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Part 1, 2, 3: Progression Free Survival (PFS)
Time Frame: Up to approximately 18 months
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Up to approximately 18 months
|
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Part 1, 2, 3: Overall survival (OS)
Time Frame: Up to approximately 18 months
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Defined as the time from first dose of study treatment to time of death.
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Up to approximately 18 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
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 Major Dates
Study Start (Actual)
June 15, 2023
Primary Completion (Estimated)
January 29, 2027
Study Completion (Estimated)
January 29, 2027
Study Registration Dates
First Submitted
March 3, 2023
First Submitted That Met QC Criteria
March 3, 2023
First Posted (Actual)
March 15, 2023
Study Record Updates
Last Update Posted (Estimated)
February 15, 2024
Last Update Submitted That Met QC Criteria
February 14, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Endocrine Gland Neoplasms
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Kidney Neoplasms
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Lung Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Carcinoma, Renal Cell
- Carcinoma, Non-Small-Cell Lung
- Colorectal Neoplasms
- Adenocarcinoma
- Ovarian Neoplasms
Other Study ID Numbers
- BP44068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org).
Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).
For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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