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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05769959
Recruitment Status : Active, not recruiting
First Posted : March 15, 2023
Last Update Posted : February 15, 2024
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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).

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Non-small Cell Lung Cancer Pancreatic Adenocarcinoma Colorectal Cancer Ovarian Neoplasms Drug: RO7515629 Drug: tocilizumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 15, 2023
Estimated Primary Completion Date : January 29, 2027
Estimated Study Completion Date : January 29, 2027


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.
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).
Other Name: Actemra, RoActemra

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.
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).
Other Name: Actemra, RoActemra

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.
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).
Other Name: Actemra, RoActemra




Primary Outcome Measures :
  1. Part 1, 2, 3: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 15 months ]
  2. 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. ]

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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05769959


Locations
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United States, Colorado
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
United States, Tennessee
Tennessee Oncology; Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT05769959    
Other Study ID Numbers: BP44068
First Posted: March 15, 2023    Key Record Dates
Last Update Posted: February 15, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hoffmann-La Roche:
HLA-G
Human leukocyte antigen G
Renal cell carcinoma
Non-small cell lung cancer
Pancreatic adenocarcinoma
Colorectal cancer
Epithelial ovarian cancer
Primary peritoneal cancer
Fallopian tube cancer
RO7515629
Tocilizumab
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Adenocarcinoma
Carcinoma, Renal Cell
Ovarian Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications