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Monoclonal Antibodies

NBE-002 for Breast Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by NBE-Therapeutics AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing NBE-002, a new treatment that combines an antibody with a drug, in patients with advanced solid tumors. It works by targeting a specific protein on cancer cells to deliver the drug directly and kill the cancer cells.

Eligible Conditions
  • Breast Cancer
  • Solid Tumors
  • Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Anti-tumor Activity (Phase 2)
Recommended Phase 2 Dose (RP2D) (Phase 1)
Secondary study objectives
Concentrations of NBE-002
Concentrations of NBE-002-reactive antibodies
Incidence of Adverse Events (Safety and Tolerability)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Safety-expansion Cohort (SEC)Experimental Treatment1 Intervention
Dose to be determined based on DEC.
Group II: Expansion Cohort 2 (EC2)Experimental Treatment1 Intervention
Dose to be determined based on DEC and SEC.
Group III: Expansion Cohort 1 (EC1)Experimental Treatment1 Intervention
Dose to be determined based on DEC and SEC.
Group IV: Dose-escalation Cohort (DEC)Experimental Treatment1 Intervention
Escalating doses of NBE-002 depending on cohort at enrollment.

Find a Location

Who is running the clinical trial?

NBE-Therapeutics AGLead Sponsor
Cmed Clinical ServicesOTHER
2 Previous Clinical Trials
165 Total Patients Enrolled

Media Library

NBE-002 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04441099 — Phase 1 & 2
Breast Cancer Research Study Groups: Expansion Cohort 2 (EC2), Dose-escalation Cohort (DEC), Safety-expansion Cohort (SEC), Expansion Cohort 1 (EC1)
Breast Cancer Clinical Trial 2023: NBE-002 Highlights & Side Effects. Trial Name: NCT04441099 — Phase 1 & 2
NBE-002 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04441099 — Phase 1 & 2
~2 spots leftby Nov 2025
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