Clinical trial · Interventional
A Study of TAK-441 in Adult Patients With Advanced Nonhematologic Malignancies
A Multicenter, Open-Label, Dose-Escalation, Phase 1 Study of TAK-441, an Oral Hedgehog Signaling Pathway Inhibitor, in Adult Patients With Advanced Nonhematologic 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)
This is the first study in which TAK-441 is administered to humans. The patient population will consist of adults aged 18 or older who have advanced nonhematologic malignancies and for whom standard treatment is no longer effective or does not offer curative or life-prolonging potential. Following completion of the dose escalation study, patients will be enrolled as part of 2 expansion cohorts.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Nonhematologic Malignancies | — | UNRESOLVED | — |
| Carcinoma, Basal Cell | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TAK-441 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TAK-441
- interventionNames
- Drug: TAK-441
Primary outcomes (1)
- measure
- Safety profile, maximum tolerated dose (MTD) or maximum feasible dose (MFD) of TAK-441 administered as an oral formulation in patients wtih advanced nonhematologic malignancies
- timeFrame
- From first dose of TAK-441 through 30 days after the last dose of TAK-441
- description
- Adverse events, serious adverse events, dose-limiting toxicities, assessments of clinical laboratory values, electrocardiogram parameters and vital sign measurements
Secondary outcomes (4)
- measure
- Single-dose and multiple-dose plasma pharmacokinetics (PK) of TAK-441
- timeFrame
- Sampling during Cycle 1 (Days 1-28)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Each patient must meet all of the following inclusion criteria to be enrolled in the study: * Male or female 18 years or older * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 * Diagnosis of a nonhematologic malignancy for which standard treatment is no longer effective or does not offer curative or life-prolonging potential * Meet other clinical, radiographic or laboratory inclusion criteria as specified in the protocol * Voluntary written consent Exclusion Criteria: Patients meeting any of the following exclusion criteria are not to be enrolled in the study: * Life-threatening illness unrelated to cancer * Receiving other treatment (radiotherapy, antineoplastics or investigational agents) within protocol specified windows of first dose of TAK-441 * Patients with brain metastases who do not meet criteria specified in study protocol * Known history of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C * Major surgery within 14 days before the first dose of TAK-441 * Infection requiring systemic therapy, or other serious infection within 14 days of the first dose of TAK-441 * Do not meet other clinical, laboratory or radiographic criteria as specified in the protocol
References
Publications (0)
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