Study of RO7515629 in Participants With HLA-G Positive Solid Tumors
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ClinicalTrials.gov Identifier: NCT05769959 |
Recruitment Status :
Terminated
(Sponsor decision (not related to safety, efficacy or quality).)
First Posted : March 15, 2023
Last Update Posted : April 22, 2024
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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 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3 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 |
Actual Primary Completion Date : | March 19, 2024 |
Actual Study Completion Date : | March 19, 2024 |
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.
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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 |
- Part 1, 2, 3: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 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. ]
- Part 1, 2, 3: Pharmacokinetic Analysis: Maximum Serum Concentration (Cmax) of RO7515629 [ Time Frame: Up to 13 months ]
- Part 1, 2, 3: Pharmacokinetic Analysis: Time of Maximum Serum Concentration (Tmax) of RO7515629 [ Time Frame: Up to 13 months ]
- Part 1, 2, 3: Pharmacokinetic Analysis: Minimum Serum Concentration (Cmin) of RO7515629 [ Time Frame: Up to 13 months ]
- Parts 1, 2, 3: Pharmacokinetic Analysis: Clearance (CL) of RO7515629 [ Time Frame: Up to 13 months ]
- Part 1, 2, 3: Pharmacokinetic Analysis: Volume of Distribution at Steady State (Vss) of RO7515629 [ Time Frame: Up to 13 months ]
- Part 1, 2, 3: Pharmacokinetic Analysis: Area Under The Curve (AUC) of RO7515629 [ Time Frame: Up to 13 months ]
- Part 1, 2, 3: Number of Participants With RO7515629 Anti-drug Antibodies (ADAs) [ Time Frame: Up to 13 months ]
- Part 1, 2, 3: Objective Response Rate (ORR) [ Time Frame: Up to approximately 18 months ]
- Part 1, 2, 3: Disease Control Rate (DCR) [ Time Frame: Up to approximately 18 months ]
- Part 1, 2, 3: Duration of Response (DoR) [ Time Frame: Up to approximately 18 months ]
- Part 1, 2, 3: Progression Free Survival (PFS) [ Time Frame: Up to approximately 18 months ]
- 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.
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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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
United States, Colorado | |
Sarah Cannon Research Institute at HealthONE | |
Denver, Colorado, United States, 80218 | |
United States, Tennessee | |
SCRI Oncology Partners | |
Nashville, Tennessee, United States, 37203 |
Study Director: | Clinical Trials | Hoffmann-La Roche |
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: | April 22, 2024 |
Last Verified: | April 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). |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |
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 |