Dose-escalation Study of Lupartumab Amadotin (BAY1129980)

ClinicalTrials.gov ID: NCT02134197

Public ClinicalTrials.gov record NCT02134197. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

View official ClinicalTrials.gov record → Back to search

ClinicalTrials.gov public records Last synced Oct 8, 2026, 1:28 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-label Phase I Dose-escalation Study to Evaluate the Safety, Tolerability, Maximum Tolerated Dose, Pharmacokinetics, and Pharmacodynamics of the Anti-C4.4a Antibody Drug Conjugate BAY1129980 in Subjects With Advanced Solid Tumors Known to Express C4.4a

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to evaluate: * The side effects of BAY1129980 when given every 21 days different dose levels. * Determine the dose level of BAY1129980 that should be tested in future clinical research studies. * Measure how much BAY1129980 is in the blood at specific times after administration. * If treatment with BAY1129980 shows any effect on reducing the tumor growth. * If there are specific biomarkers that might be able to explain why some patients respond to treatment and others do not. * If treatment with BAY1129980 causes an immune response from the body against the drug (immunogenicity).

Study identification

NCT ID: NCT02134197
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 1
Lead sponsor: Bayer; Industry
Enrollment: 69 participants

Conditions and interventions

Conditions

Neoplasms

Interventions

Lupartumab Amadotin (BAY1129980) Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 22, 2014 (Actual)
Primary completion: Aug 30, 2018 (Actual)
Completion: Aug 30, 2018 (Actual)
Last update posted: Dec 11, 2019

2014 – 2018

United States locations

U.S. sites: 15
U.S. states: 12
U.S. cities: 15

Facility	City	State	ZIP	Site status
Not listed	La Jolla	California	92093	—
Not listed	Stanford	California	94305	—
Not listed	Aurora	Colorado	80045	—
Not listed	Washington D.C.	District of Columbia	20007-2197	—
Not listed	Gainesville	Georgia	32610	—
Not listed	Westwood	Kansas	66205	—
Not listed	Hackensack	New Jersey	07601	—
Not listed	Buffalo	New York	14263	—
Not listed	New York	New York	—	—
Not listed	Durham	North Carolina	27710	—
Not listed	Philadelphia	Pennsylvania	19104	—
Not listed	Nashville	Tennessee	37203	—
Not listed	Dallas	Texas	75230	—
Not listed	Houston	Texas	77030	—
Not listed	Seattle	Washington	98109-1023	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02134197, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Dec 11, 2019 · Synced Oct 8, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02134197 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →