First-in-man Dose Escalation Study of BAY1179470 in Patients With Advanced, Refractory Solid Tumors

Bayer

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: BAY1179470

Study type: Interventional

Funder types: Industry

Identifiers

NCT01881217

16182

Details and patient eligibility

About

An open-label, non-randomized, Phase I dose-escalation study designed to assess the safety, tolerability, pharmacokinetics(PK) /pharmacodynamics( PD) and tumor response profile of BAY1179470 in subjects with advanced, refractory solid tumors

Enrollment: 35 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with advanced, histologically or cytologically confirmed solid tumors refractory to any standard therapy or have no standard therapy available or subjects actively refuse any treatment which would be regarded standard
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 and a life expectancy of at least 3 months
• Adequate bone marrow, liver, and renal function.

For subjects in the additional cohort:

• Subjects with advanced, histologically or cytologically confirmed gastric cancer.
• At least moderate FGFR2 expression in the tumor tissue from archival samples is confirmed

Exclusion criteria

• History of severe allergic reactions to monoclonal antibody therapy
• Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 90 mmHg, despite optimal medical management
• Any condition that is unstable or could jeopardize the safety of the subject and his / her compliance in the study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 3 patient groups

BAY1179470 (Dose escalation)

Experimental group

Description:

BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days.

Treatment:

Drug: BAY1179470

BAY1179470 (additional)

Experimental group

Description:

Additional cohort: BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days.

Treatment:

Drug: BAY1179470

BAY1179470 (expansion)

Experimental group

Description:

Expansion cohort: BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days.

Treatment:

Drug: BAY1179470