Clinical trial · Interventional
First-in-man Dose Escalation Study of BAY1179470 in Patients With Advanced, Refractory Solid Tumors
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.
NCT01881217CI-TRIAL-00029529completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BAY1179470 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- BAY1179470 (Dose escalation)
- description
- BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days.
- interventionNames
- Drug: BAY1179470
- type
- EXPERIMENTAL
- label
- BAY1179470 (additional)
- description
- Additional cohort: BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days.
- interventionNames
- Drug: BAY1179470
- type
- EXPERIMENTAL
- label
- BAY1179470 (expansion)
- description
- Expansion cohort: BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.