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Targeted Alpha Therapy

BAY2701439 for Cancer

Phase 1
Waitlist Available
Research Sponsored by Bayer
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 after first administration of study intervention up to 42 days after the last dose of study intervention
Awards & highlights

Study Summary

This trial is to study the safety of a new drug, BAY2701439, for people with advanced cancer that has the protein HER2.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 42 days after first administration of study intervention on cycle 1 (42 days) day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 42 days after first administration of study intervention on cycle 1 (42 days) day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose escalation: Frequency of DLTs at each dose level
Dose escalation: Incidence of TEAEs including TESAEs
Dose escalation: Severity of TEAEs including TESAEs
+3 more
Secondary outcome measures
AUC(0-42 days) of radium-223
AUC(0-42 days) of thorium-227
AUC(0-42 days) of total antibody
+6 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Other HER2 overexpressing advanced carcinomasExperimental Treatment1 Intervention
Dose expansion of BAY2701439
Group II: HER2 overexpressing breast cancerExperimental Treatment1 Intervention
Dose expansion of BAY2701439
Group III: HER2 low expressing breast cancerExperimental Treatment1 Intervention
Dose expansion of BAY2701439
Group IV: Dose escalation of BAY2701439Experimental Treatment1 Intervention
The target population consists of participants with advanced HER2-expressing/amplified breast, gastric or gastroesophageal cancer.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BAY2701439
2020
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,237 Previous Clinical Trials
25,326,964 Total Patients Enrolled

Media Library

BAY2701439 (Targeted Alpha Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04147819 — Phase 1
Cancer Research Study Groups: HER2 overexpressing breast cancer, Other HER2 overexpressing advanced carcinomas, Dose escalation of BAY2701439, HER2 low expressing breast cancer
Cancer Clinical Trial 2023: BAY2701439 Highlights & Side Effects. Trial Name: NCT04147819 — Phase 1
BAY2701439 (Targeted Alpha Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04147819 — Phase 1

Frequently Asked Questions

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

How many volunteers are participating in this experiment?

"This clinical trial requires that 213 suitable patients partake in the study, located at Washington University School of Medicine (Saint Louis) and University of Texas MD Anderson Cancer Center (Houston)."

Answered by AI

Are there various locations where this experiment is taking place within the state?

"This trial is presently enrolling at 4 centres, located in Saint Louis, Houston and New york. There are also other sites available to minimize the burden of travel for participants."

Answered by AI

What goals is this clinical trial attempting to accomplish?

"The principal objective of this research project is to evaluate the safety and tolerability of BAY2701439 via a 42-day period following administration. Secondary outcomes encompass determining the recommended dose level for expansion cohorts, measuring radium-223's area under the curve over 42 days, as well as ascertaining total antibody maximum exposure."

Answered by AI

Does this research initiative need additional participants?

"This study, which was initially published on July 2nd 2020 and recently amended on November 18th 2022, is actively seeking participants. Clinicaltrials.gov has the most up to date information regarding recruitment status."

Answered by AI

Has the FDA endorsed BAY2701439 for therapeutic use?

"Our assessment of BAY2701439's safety is a 1, as this early-phase trial has only provided limited evidence for its effectiveness and security."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A First in Human Study of BAY2701439 to Look at Safety, How the Body Absorbs, Distributes and Excretes the Drug, and How Well the Drug Works in Participants With Advanced Cancer Expressing the HER2 Protein
2020. "A First in Human Study of BAY2701439 to Look at Safety, How the Body Absorbs, Distributes and Excretes the Drug, and How Well the Drug Works in Participants With Advanced Cancer Expressing the HER2 Protein". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04147819.
~3 spots leftby Apr 2025
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