Clinical trial · Interventional
Thorough ECG (Electrocardiogram) and Drug Interaction Study With Anetumab Ravtansine and Itraconazole
An Open Label, Phase I Study to Assess the Effect of Itraconazole (CYP3A4 and P-gp Inhibitor) on the Pharmacokinetics of Anetumab Ravtansine and to Assess the ECG Effects, Safety and Immunogenicity of Anetumab Ravtansine Given as a Single Agent and Together With Itraconazole in Subjects With Mesothelin-expressing Advanced Solid Cancers
- 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)
Characterize the safety, tolerability, ECG effects, pharmacokinetics and immunogenicity of anetumab ravtansine given as single agent and after inhibition of CYP3A4 and P-gp by concomitant administration of itraconazole in subjects with mesothelin-expressing advanced solid cancers
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 |
|---|---|---|---|
| Anetumab ravtansine (BAY94-9343) | Drug | — | UNRESOLVED |
| Itraconazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Anetumab ravtansine
- description
- The evaluation of multiple ECG parameters and the drug-drug interaction (DDI) potential of anetumab ravtansine parameters when administered alone and together with itraconazole 100 mg oral capsules will be conducted in 2 sequential parts. On Cycle 1 Day 1, anetumab ravtansine will be given alone at a dose of 6.5 mg/kg in Part 1 and Part 2. On Cycle 2 Day 1, anetumab ravtansine will be given together with itraconazole at a dose of 0.6 mg/kg in Part 1, and at a dose of 6.5 mg/kg (planned) in Part 2.
- interventionNames
- Drug: Anetumab ravtansine (BAY94-9343)
- Drug: Itraconazole
Primary outcomes (10)
- measure
- PR interval duration
- timeFrame
- Up to 2 months per patient
- description
- ECG evaluation
- measure
- QRS interval duration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects must have histologically confirmed, locally advanced or metastatic solid cancers of the following histological types: 1. predominantly epithelial (≥50% tumor component) pleural or peritoneal mesothelioma 2. epithelial ovarian cancer (fallopian tube and primary peritoneal cancers are eligible) 3. adenocarcinoma of the pancreas, 4. triple-negative adenocarcinoma of the breast 5. non-small-cell adenocarcinoma of the lung 6. gastric cancer (including gastro-esophageal junction) 7. colon cancer 8. cholangiocarcinoma 9. Thymic carcinoma * Subjects must have no standard therapy available, or have actively refused standard therapy * Subjects must provide samples of archival tumor tissue collected and submitted anytime during the study * Subjects must have a life expectancy of at least 12 weeks * Subjects must have ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1 * Subjects must have adequate bone marrow, renal and hepatic function and coagulation * Subjects must have normal or clinically insignificant ECG at screening * Women of reproductive potential must have a negative serum pregnancy test obtained within 3 days before the start of anetumab ravtansine * Women of childbearing potential and fertile men must agree to use adequate contraception when sexually active. This applies from the time period between signing of the informed consent until at least 6 months after the last administration of the last study drug. Male patients with a female partner of childbearing potential must use a condom and ensure that an additional form of contraception is also used during treatment and until 6 months after last study drug administration. Exclusion Criteria: * Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, except cervical carcinoma in situ, treated basal cell carcinoma, superficial noninvasive bladder tumors or any previous cancer curatively treated ≥ 3 years before the start of anetumab ravtansine * New or progressive brain or meningeal or spinal metastases * Corneal epitheliopathy or any eye disorder that may predispose the subjects to drug-induced corneal epitheliopathy, or may interfere with diagnosis of treatment-emergent corneal epitheliopathy at the ophthalmologist's or the investigator's discretion * History or current evidence of * biliary cirrhosis * malignant biliary obstruction unless the bile flow to the gastrointestinal tract is maintained by a fully operational biliary stent * CTCAE (Common Terminology Criteria for Adverse Events) Grade ≥2 bleeding disorder within 4 weeks before the start of anetumab ravtansine * uncontrolled cardiovascular disease or uncontrolled hypertension * Long QT Syndrome * HIV infection * Hepatitis B or C infection * Had a major surgery or significant trauma within 4 weeks before the start of anetumab ravtansine * Had solid organ or bone marrow transplantation * Have LVEF (left ventricular ejection fraction) \<50% at screening * Have QTc \>450 ms or heart rate ≥100 bpm or ≤45 bpm at screening * Poor CYP2D6 metabolizers based on the screening test for genetic polymorphisms in CYP2D6 metabolizing capacity
References
Publications (0)
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