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Monoclonal Antibodies

RO6874281 for Breast Cancer

Phase 1
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 up to 24 months
Awards & highlights

Study Summary

This trial will study the safety and effectiveness of RO6874281 as a cancer treatment, either alone or in combination with other drugs.

Eligible Conditions
  • Solid Tumors
  • Breast Cancer
  • Head and Neck Cancers

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Concentration-Time Curve (AUC) of RO6874281
Maximum Observed Serum Concentration (Cmax) of RO6874281
Maximum Tolerated Dose (MTD) of RO6874281
+5 more
Secondary outcome measures
Density of CD20 Cells in Tumor Samples
Density of CD3-/Perforin+ Cells in Tumor Samples
Density of Cluster of Differentiation (CD)8+ Cells in Tumor Samples
+11 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part C: RO6874281 in Combination with CetuximabExperimental Treatment2 Interventions
RO6874281 will be administered as an IV infusion. The starting dose regimen of RO6874281 in combination with cetuximab will be 5 mg QW for the first 4 administrations, then Q2W. Cetuximab will be administered Q2W at 500 milligrams per square meter (mg/m^2). Different regimens may be explored based on the emerging safety, PK, and PD data of RO6874281 and may be tested in parallel. Participants will be treated with RO6874281 in combination with cetuximab until disease progression, unacceptable toxicities, or withdrawal of consent. Participants may continue treatment with RO6874281 in combination with cetuximab for a maximum of 24 months. Extension Phase: The MTD for RO6874281 was determined to be 10mg and therefore patients in the extension will be treated with 10mg RO6874281. Cetuximab and R06874281 will be administered weekly during induction phase (cycle 1 and cycle 2). Both IMPs will be administered Q2W starting in cycle 3.
Group II: Part B: RO6874281 in Combination with TrastuzumabExperimental Treatment2 Interventions
Dose Escalation: RO6874281 will be administered as an IV infusion. RO6874281 will be administered QW for the first 4 administrations, then Q2W. The standard dose for trastuzumab will be a loading dose of 6 milligrams per kilogram (mg/kg) followed by a maintenance dose of 4 mg/kg from Cycle 2 in a Q2W regimen. Different regimens may be explored based on the emerging safety, PK, and PD data of RO6874281 and may be tested in parallel. Participants will be treated with RO6874281 in combination with trastuzumab until disease progression, unacceptable toxicities, or withdrawal of consent. Participants may continue treatment with RO6874281 in combination with trastuzumab for a maximum of 24 months.
Group III: Part A: RO6874281 MonotherapyExperimental Treatment1 Intervention
Dose Escalation: RO6874281 will be administered as an intravenous (IV) infusion. The starting dose regimen of RO6874281 as a single agent will be 5 milligrams (mg) once weekly (QW). Different regimens may be explored based on the emerging safety, PK, and PD data of RO6874281 and may be tested in parallel. Participants will be treated with RO6874281 until disease progression, unacceptable toxicities, or withdrawal of consent. Participants may continue treatment with RO6874281 for a maximum of 24 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
2011
Completed Phase 3
~2480
RO6874281
2015
Completed Phase 1
~290
Trastuzumab
2014
Completed Phase 4
~5190

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,931 Total Patients Enrolled
159 Trials studying Breast Cancer
91,333 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,198 Previous Clinical Trials
888,311 Total Patients Enrolled
137 Trials studying Breast Cancer
71,962 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
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)
2015. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02627274.
~14 spots leftby Apr 2025
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