Clinical trial · Interventional
Phase I Study of Oral BAY 1217389 in Combination With Intravenous Paclitaxel
An Open-label Randomized Two-arm Phase I Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of Oral BAY 1217389 in Combination With Weekly Intravenous Paclitaxel Given in an Intermittent Dosing Schedule in Subjects With Advanced Malignancies
- 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)
Determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of oral BAY1217389 given in combination with intravenous (IV) paclitaxel using an intermittent dosing schedule (2 days on / 5 days off) in subjects with advanced malignancies.
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 |
|---|---|---|---|
| Medical Oncology | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BAY1217389 | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Experimental Treatment (combination of BAY1217389 with paclitaxel in an intermittent dosing schedule) Expansion Cohort - Maximum tolerated dose of BAY1217389 and Paclitaxel
- interventionNames
- Drug: BAY1217389
- Drug: Paclitaxel
- type
- PLACEBO_COMPARATOR
- label
- Arm 2
- description
- Standard Treatment (Single-agent Paclitaxel )
- interventionNames
- Drug: BAY1217389
- Drug: Paclitaxel
Primary outcomes (7)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female subjects aged \>/= 18 years. * Study population: * For the dose-escalation cohorts: Subjects with histologically or cytologically confirmed advanced malignancies (solid tumors), refractory to any standard therapy, have no standard therapy available * For the expansion cohort: Subjects with advanced, histologically or cytologically confirmed triple-negative breast cancer (TNBC), refractory to any standard therapy, have no standard therapy available, or subjects actively refused any standard treatment and / or if, in the judgment of the investigator, experimental treatment is clinically acceptable. * Subjects must have evaluable or measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Life expectancy of at least 12 weeks. * Adequate bone marrow, liver, and renal functions. Exclusion Criteria: * Known hypersensitivity to the study drugs or excipients of the preparations or any agent given in association with this study. * Evidence of peripheral neuropathy of Grade \>2. * History of cardiac disease: congestive heart failure New York Heart Association (NYHA) class \>II, unstable angina (anginal symptoms at rest), new-onset angina (within the past 3 months before study entry), myocardial infarction within the past 3 months before study entry, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers, calcium channel blockers, and digoxin are permitted). * Uncontrolled hypertension defined as systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg, despite optimal medical management. * Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C. * History of human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection.
References
Publications (0)
Data not yet available