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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

Study Summary

This trial will study a new cancer drug to see if it is safe and effective.

Eligible Conditions

Solid Tumors
Cancer
Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Anti-tumor Activity (Phase 2)

Recommended Phase 2 Dose (RP2D) (Phase 1)

Secondary outcome measures

Concentrations of NBE-002

Concentrations of NBE-002-reactive antibodies

Incidence of Adverse Events (Safety and Tolerability)

+1 more

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.

Do I qualify?Apply below to find out

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap on participant enrollment for this trial?

"Affirmative. The clinicaltrials.gov page reveals that this experiment is presently recruiting participants, which it initially began doing on June 19th 2020 and updated most recently on March 3rd 2022. It necessitates 100 patients to be recruited from 3 distinct medical centres."

Answered by AI

What is the end goal of this medical experiment?

"As per the research sponsor, NBE-Therapeutics AG, this will be a long-term study spanning up to 60 months. The primary outcome that will be monitored is determining the Recommended Phase 2 Dose (RP2D). Additionally, secondary measures such as Immunogenicity profile through measuring concentrations of NBE-002 reactive antibodies, Preliminary Anti-tumor Activity via Response Evaluation Criteria in Solid Tumours v1.1 and Pharmacokinetic profile by monitoring levels of NBE-002 are also part of the evaluation criteria."

Answered by AI

Are there any vacancies remaining in this clinical trial?

"Clinicaltrials.gov reveals that this trial is in progress, having been initially published on June 19th 2020 and recently updated on March 3rd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

NBE-002 in Patients With Advanced Solid Tumors

2020. "NBE-002 in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04441099.