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A Study Evaluating Safety, Pharmacokinetics, and Therapeutic Activity of RO6874281 as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C) | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study Evaluating Safety, Pharmacokinetics, and Therapeutic Activity of RO6874281 as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C)

An Open-Label, Multicenter, Dose-Escalation, Phase Ia/Ib Study to Evaluate Safety, Pharmacokinetics, and Therapeutic Activity of RO6874281, an Immunocytokine Consisting of Interleukin 2 Variant (IL-2v) Targeting Fibroblast Activation Protein-α (FAP), as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C)

NCT02627274•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This first-in-human, open-label, multicenter, Phase Ia/Ib, adaptive, multiple ascending-dose study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of RO6874281 as a single agent (Part A) or in combination with trastuzumab or cetuximab (Part B or C).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Radiologically measurable and clinically evaluable disease
•Absence of rapid disease progression or threat to vital organs or critical anatomical sites requiring urgent alternative medical intervention
•Confirmed at least one tumor lesion with location accessible to safely biopsy per clinical judgment (special requirements apply for Part C; Participants with only one target lesion and no non-target lesions can enroll after documented agreement with the Medical Monitor).
•Life expectancy of greater than or equal to (\>=12) weeks
•Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
•Participants with unilateral pleural effusion (other than non-small cell lung cancer \[NSCLC\] indication) should fulfill the following criteria for pulmonary and cardiac functions: Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification 0 - 1 level and New York Heart Association (NYHA) classification class 1 or better
•Forced expiratory volume 1 (FEV1) \>70% and forced vital capacity (FVC) \>70% of predicted value; participants with lung metastases should present with DLCO \>60% of predicted value
•Adequate cardiovascular, hematological, liver and renal function
•All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to grade less than or equal to (\<=) 1, except alopecia (any grade) and Grade 2 peripheral neuropathy
•Negative serum pregnancy test within 7 days prior to study treatment in premenopausal women and women less than (\<) 12 months after menopause
+6 more criteria

Exclusion Criteria

•History of, active, or suspicion of autoimmune disease (exceptions apply)
•Adverse events from prior anti-cancer therapy that have not resolved to Grade 1, except for alopecia, vitiligo, or endocrinopathies managed with replacement therapy
•Symptomatic or untreated central nervous system (CNS) metastases
•History of treated asymptomatic CNS metastases with any of the following: Metastases to the brain stem, midbrain, pons, medulla, cerebellum, or within 10 millimeters (mm) of the optic nerves and chiasm; history of intracranial or spinal cord hemorrhage; lacking radiographic demonstration of improvement upon the completion of CNS-directed therapy and evidence of progression between completion of therapy and the baseline radiographic study; ongoing requirement for dexamethasone; stereotactic or whole brain radiation within 28 days before the start of study treatment; last CNS radiographic study less than 4 weeks since completion of radiotherapy and less than 2 weeks since the discontinuation of corticosteroids; CNS metastases treated by resection or brain biopsy performed within 28 days before the start of study treatment
•Participants with an active second malignancy
•Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders, and known autoimmune diseases or other disease with ongoing fibrosis
•Significant cardiovascular/cerebrovascular disease within 6 months prior to Day 1 of study drug administration
•Active or uncontrolled infections
•Known human immunodeficiency virus (HIV) or known active hepatitis B virus or hepatitis C virus infection
•History of chronic liver disease or evidence of hepatic cirrhosis
+14 more criteria

Locations (26)

University of Arizona Cancer Center

Tucson, Arizona, United States

UCSD - Moores Cancer Center

La Jolla, California, United States

Banner MD Anderson Cancer Center

Greeley, Colorado, United States

Washington University; Division of Oncology

St Louis, Missouri, United States

The Ohio State University

Columbus, Ohio, United States

UZ Antwerpen

Edegem, Belgium

Juravinski Cancer Clinic; Department of Oncology

Hamilton, Ontario, Canada

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Rigshospitalet; Onkologisk Klinik

København Ø, Denmark

Institut Bergonie; Oncologie

Bordeaux, France

Key Dates

Start Date

December 7, 2015

Primary Completion Date

November 10, 2022

Completion Date

November 10, 2022

Last Updated

November 22, 2022

Enrollment

134

ACTUAL participants

Conditions

Solid TumorBreast CancerCancer of Head and Neck

Interventions

RO6874281

DRUG

Trastuzumab

DRUG

Cetuximab

DRUG

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

NCT05245812

Breast CancerHigh Risk of Breast Cancer

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RECRUITINGPHASE1

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

NCT04704661

Advanced Breast CarcinomaAdvanced Colon Carcinoma+38 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 22, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study Evaluating Safety, Pharmacokinetics, and Therapeutic Activity of RO6874281 as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C)

Inclusion Criteria

Exclusion Criteria

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

A Study of PYX-201 in Advanced Solid Tumors

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer