Trial Condition(s):
Neoplasms
First-in-man dose escalation study of BAY1179470 in patients with advanced, refractory solid tumors
Bayer Identifier:
16182
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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
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 Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Kashiwa, Japan, 277-8577 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chuo-ku, Japan, 104-0045 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Koto-ku, Japan, 135-8550 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kita-Adachigun, Japan, 362-0806 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fukuoka, Japan, 811-1395 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 138-736 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Singapore, Singapore, 119074 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Singapore, Singapore, 169610 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
An open-label, Phase I, dose-escalation study to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous BAY 1179470 in subjects with advanced, refractory solid tumors.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Number of participants with Adverse Events as a Measure of Safety and TolerabilityTimeframe: Up to 2 years
- Maximum drug concentration versus time curve (AUC) from zero to infinity after single (first) and multiple doses of BAY1179470Timeframe: Cycle 1 and 2: pre-dose, 0.5, 1 , 2, 3, 5, 8, 24, 48, 72, 168 and 336 hours after start of the infusion, Cycle 3 and 4: pre-dose and 1 hour after start of the infusion; each cycle is 21 days
- Maximum drug concentration (Cmax) and minimal drug concentration (Cmin) of BAY1179470 in plasma after single and multiple dose administrationTimeframe: Cycle 1 and 2: pre-dose, 0.5, 1 , 2, 3, 5, 8, 24, 48, 72, 168 and 336 hours after start of the infusion, Cycle 3 and 4: pre-dose and 1 hour after start of the infusion; each cycle is 21 days
Secondary Outcome
- Tumor responseTumor response will be evaluated based on the RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria.Timeframe: Every 42 days
- Biomarker (plasma)Timeframe: Cycle 1: pre-dose, 24 hours after start of the infusion and Day 15, Cycle 2, 3 and 4: pre-dose; each cycle is 21 days
- Biomarker (biopsy)Additional cohort onlyTimeframe: Cycle 1: pre-dose and Day 8; cycle 1 is 21 days
- ImmunogenicityAnalyzed for anti-BAY 1179470 antibodiesTimeframe: Cycle 1 and Cycle 2 pre-dose and every second cycle thereafter pre-dose. End of treatment visit and follow-up visit up to 2 years; each cycle is 21 days
Additional Information
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