CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 133 enrolled
Drug / intervention
Xentuzumab +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03099174
NCT03099174Phase 1Completed
CompareCT.gov

An Open Label, Phase Ib, Dose-escalation Study Evaluating the Safety and Tolerability of Xentuzumab and Abemaciclib in Patients With Locally Advanced or Metastatic Solid Tumours and in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-positive, HER2-, Breast Cancer, Followed by Expansion Cohorts.

Boehringer Ingelheim·interventional·Posted Apr 4, 2017·Updated Jun 24, 2025

In Brief

A Phase 1 clinical trial evaluating Xentuzumab, Abemaciclib, and 3 other interventions for Neoplasms and Breast Neoplasms. Completed, enrolled 133 participants across 30 sites in 7 countries.

Detailed Summary

This is a study in adult patients with different types of cancer. The purpose of this study is to find a safe dose of: * Xentuzumab in combination with abemaciclib * Xentuzumab in combination with abemaciclib and hormonal therapies The study also tests whether these medicines make tumours shrink in participants with lung and breast cancer. Participants can stay in the study as long as they benefit from and can tolerate treatment. All participants get xentuzumab infusions and abemaciclib tablets. Participants who have breast cancer get different types of hormonal therapies in addition to xentuzumab and abemaciclib. For all participants, the size of the tumour is measured regularly. Doctors also regularly check the general health of the participants."

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Breast Neoplasms
CountriesDenmark, Finland, France, Japan, South Korea, Spain, United States
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 4, 2017
Enrollment StartMay 4, 2017
Primary CompletionMay 31, 2023
Study CompletionMay 16, 2024
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 9.2 years ago

Interventions

Xentuzumabdrug

Once weekly administrated through one hour intravenous infusion

Abemaciclibdrug

Treatment/28-day cycle p.o. Q12H on Days 1-28 (dose determined in Cohort A) Abbreviations: PO = orally; Q12H = every 12 (± 2) hours

Letrozoledrug

Once a day

Anastrozoledrug

Once a day

Fulvestrantdrug

Once a month, with an additional dose given two weeks after the first dose. Each dose is given as two slow injections lasting one to two minutes, with one injection being given into the muscle of each buttock

Abemaciclibdrug

Treatment/28-day cycle p.o. Q12H on Days 1-28 (dose determined in Cohort D) Abbreviations: PO = orally; Q12H = every 12 (± 2) hours