Dose-escalation Study of Lupartumab Amadotin (BAY1129980)

Neoplasms Clinical Trial

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

Status Terminated

Clinical Trial Summary

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).

Clinical Trial Description

The relatively restricted C4.4a expression pattern provides a target for the selective delivery of a cytotoxic drug to C4.4.a-expressing tumor cells by means of a suitable antibody-drug conjugate. The subject population eligible for the current study will be those subjects with advanced malignancies known to express C4.4a, which are refractory to standard therapy or those without standard therapy or actively refusing any treatment, which would be regarded as standard and in whom, in the opinion of the investigator, experimental therapy with BAY1129980 may be beneficial.Depending on the number of dose-escalating steps and the occurrence of DLTs, the planned numbers of subjects could vary.It is expected that up to 90 subjects may participate in the dose-expansion phase of the study and up to 6-9 subjects may particpate in the dose re-esclation phase.The study assessments in the expansion phase of the study are identical to those in the dose-escalation phase.

Amendment # 3 includes changes to DLT criteria (hematological and non-hematological) and allows for frequent follow-up for subjects experiencing drug-related liver toxicity that warrants dose reduction or dose interruptions. ;

Related Conditions & MeSH terms

• Neoplasms

• NCT number: NCT02134197
• Study type: Interventional
• Source: Bayer
• Status: Terminated
• Phase: Phase 1
• Start date: May 22, 2014
• Completion date: August 30, 2018