BAY2701439 for Malignant Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Malignant Neoplasms
BAY2701439 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Malignant Neoplasms

Study Objectives

6 Primary · 9 Secondary · Reporting Duration: Up to 42 days after first administration of study intervention on cycle 1 (42 days) day 1

Day 42
Dose escalation: Incidence of TEAEs including TESAEs
Dose escalation: Severity of TEAEs including TESAEs
Dose expansion: Frequency of TEAEs
Dose expansion: Severity of TEAEs
Cycle 1 (42 days)
AUC(0-42 days) of radium-223
AUC(0-42 days) of thorium-227
AUC(0-42 days) of total antibody
Cmax of radium-223
Cmax of thorium-227
Cmax of total antibody
Day 42
Dose escalation: Recommended dose level(s) of BAY2701439 for the dose expansion cohorts
Therapeutic procedure
Dose expansion: Recommended dose for further clinical development of BAY2701439
Month 12
Dose expansion: ORR by RECIST 1.1 based on Investigator review
Day 42
Dose escalation: Frequency of DLTs at each dose level

Trial Safety

Safety Progress

1 of 3

Other trials for Malignant Neoplasms

Trial Design

4 Treatment Groups

HER2 overexpressing breast cancer
1 of 4
Dose escalation of BAY2701439
1 of 4
HER2 low expressing breast cancer
1 of 4
Other HER2 overexpressing advanced carcinomas
1 of 4
Experimental Treatment

213 Total Participants · 4 Treatment Groups

Primary Treatment: BAY2701439 · No Placebo Group · Phase 1

HER2 overexpressing breast cancerExperimental Group · 2 Interventions: BAY2701439, BAY2701438 · Intervention Types: Drug, Drug
Dose escalation of BAY2701439Experimental Group · 2 Interventions: BAY2701439, BAY2701438 · Intervention Types: Drug, Drug
HER2 low expressing breast cancerExperimental Group · 2 Interventions: BAY2701439, BAY2701438 · Intervention Types: Drug, Drug
Other HER2 overexpressing advanced carcinomasExperimental Group · 2 Interventions: BAY2701439, BAY2701438 · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 42 days after first administration of study intervention on cycle 1 (42 days) day 1

Who is running the clinical trial?

BayerLead Sponsor
2,140 Previous Clinical Trials
23,767,748 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have an ECOG PS of 0 or 1.
You have a life expectancy of at least 6 months.
You are at least 18 years of age.
Patients with HER2-expressing, unresectable locally advanced or metastatic gastric, gastroesophageal, or breast cancer must have evaluable disease by RECIST 1.1, assessed by local imaging.
You have HER2-positive breast cancer that has relapsed after standard treatment options, or for which no standard treatment is available.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 15th, 2021

Last Reviewed: October 8th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.