A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers
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| ClinicalTrials.gov Identifier: NCT03448042 |
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Recruitment Status :
Recruiting
First Posted : February 27, 2018
Last Update Posted : May 19, 2023
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Sponsor:
Genentech, Inc.
Information provided by (Responsible Party):
Genentech, Inc.
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Brief Summary:
This study will evaluate the safety, tolerability, and pharmacokinetics of Runimotamab administered intravenously as a single agent and in combination with Trastuzumab in participants with locally advanced or metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-expressing cancers.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Solid Tumors | Drug: Runimotamab Drug: Trastuzumab Drug: Tocilizumab | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 537 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase Ia/Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Runimotamab Administered Intravenously as a Single Agent and in Combination With Trastuzumab in Patients With Locally Advanced or Metastatic HER2-Expressing Cancers |
| Actual Study Start Date : | June 6, 2018 |
| Estimated Primary Completion Date : | April 30, 2024 |
| Estimated Study Completion Date : | April 30, 2024 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Trastuzumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Dose Escalation
Participants will be assigned sequentially to escalating doses of runimotamab up to the maximum tolerated dose (MTD).
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Drug: Runimotamab
Runimotamab will be administered via IV infusion until disease progression, intolerable toxicity, or any other discontinuation criteria are met.
Other Names:
Drug: Trastuzumab Trastuzumab will be administered via IV infusion Drug: Tocilizumab Participants will receive IV tocilizumab if needed |
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Experimental: Dose Expansion
Participants will receive runimotamab based on the MTD or maximum allowed dose (MAD) identified during dose escalation.
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Drug: Runimotamab
Runimotamab will be administered via IV infusion until disease progression, intolerable toxicity, or any other discontinuation criteria are met.
Other Names:
Drug: Trastuzumab Trastuzumab will be administered via IV infusion Drug: Tocilizumab Participants will receive IV tocilizumab if needed |
Primary Outcome Measures :
- Percentage of Participants with Adverse Events [ Time Frame: From baseline through end of study (approximately 78 months) ]
Secondary Outcome Measures :
- Serum Concentration of Runimotamab [ Time Frame: At predefined intervals from Cycle 1, Day 1 (approximately 1 year) ]
- Area Under the Serum Concentration vs. Time Curve (AUC) of Runimotamab [ Time Frame: At predefined intervals from Cycle 1, Day 1 (approximately 1 year) ]
- Maximum Observed Serum Concentration (Cmax) of Runimotamab [ Time Frame: At predefined intervals from Cycle 1, Day 1 (approximately 1 year) ]
- Minimum Observed Serum Concentration (Cmin) of Runimotamab [ Time Frame: At predefined intervals from Cycle 1, Day 1 (approximately 1 year) ]
- Clearance (CL) of Runimotamab [ Time Frame: At predefined intervals from Cycle 1, Day 1 (approximately 1 year) ]
- Volume of Distribution at Steady State (Vss) of Runimotamab [ Time Frame: At predefined intervals from Cycle 1, Day 1 (approximately 1 year) ]
- Objective Response (OR) as Determined by the Investigator According to Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) [ Time Frame: Baseline through the end of study (approximately 78 months) ]
- Duration of Response (DOR) [ Time Frame: From the first occurrence of a documented objective response to first documented disease progression or death from any cause, through the end of the study (approximately 78 months) ]
- Anti-Drug Antibody (ADA) Levels of Runimotamab [ Time Frame: At predefined intervals from Cycle 1, Day 1 (approximately 1 year) ]
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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
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate hematologic and end-organ function
- Acute, clinically significant treatment-related toxicity from prior therapy must have resolved to Grade </=1 prior to study entry
- Left Ventricular Ejection Fraction (LVEF) >/=50%
HER2-Expressing Breast Cancer-Specific Inclusion Criteria
- Locally tested, Human Epidermal Growth Factor Receptor 2 (HER2)-expressing BC
- Locally advanced or metastatic BC that has relapsed or is refractory to established therapies
HER2-Expressing Gastric/Gastroesophageal (GEJ) Cancer-Specific Inclusion Criteria
- Adenocarcinoma of the stomach or GEJ with inoperable locally advanced or recurrent and/or metastatic disease, not amenable to curative therapy
- HER2-expressing tumor (primary tumor or metastasis) as assessed by local lab testing
- HER2-positive gastric/GEJ cancer must have received prior trastuzumab, cisplatin (or carboplatin or oxaliplatin or investigational platinum agent) and 5-fluorouracil (5-FU)/capecitabine
HER2-Positive Solid Tumor Specific Inclusion Criteria
- HER2-positive tumor (primary tumor or metastasis) as assessed by local (non-central) laboratory testing
- Locally advanced, recurrent, or metastatic incurable malignancy that has progressed after at least one available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable, or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care; or for whom a clinical trial of an investigational agent is considered an acceptable treatment option
Exclusion Criteria
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 140 days after the last dose of runimotamab
- Significant cardiopulmonary dysfunction
- Known clinically significant liver disease
- Positive for acute or chronic Hepatitis B virus (HBV) infection
- Acute or chronic Hepatitis C virus (HCV) infection
- Human Immunodeficiency Virus (HIV) seropositivity
- Poorly controlled Type 2 diabetes mellitus
- History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias
- Current treatment with medications that are well known to prolong the Q-wave/T-wave (QT) interval
- Known clinically significant liver disease
- Primary central nervous system (CNS) malignancy, untreated CNS metastases, or active CNS metastases (progressing or requiring corticosteroids for symptomatic control)
- Leptomeningeal disease
- Spinal cord compression that has not definitively treated with surgery and/or radiation
- History of autoimmune disease
- Prior allogeneic stem cell or solid organ transplantation
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): NCT03448042
Contacts
| Contact: Reference Study ID Number: GO40311 https://forpatients.roche.com/ | 888-662-6728 (U.S. and Canada) | global-roche-genentech-trials@gene.com |
Locations
Show 33 study locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
| Study Director: | Clinical Trials | Genentech, Inc. |
| Responsible Party: | Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT03448042 |
| Other Study ID Numbers: |
GO40311 |
| First Posted: | February 27, 2018 Key Record Dates |
| Last Update Posted: | May 19, 2023 |
| Last Verified: | May 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Trastuzumab Antineoplastic Agents, Immunological Antineoplastic Agents |