Clinical trial · Interventional
First in Human Trial of TAS266 in Patients With Advanced Solid Tumors
A Phase I, Open-label Dose Escalation Study With Safety Expansion of TAS266 Administered by IV Infusion to Patients With Advanced Solid Tumors
NCT01529307CI-TRIAL-00049058terminatedPhase 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)
This study will assess safety, tolerability, maximum tolerated dose or recommended dose for expansion of TAS266 administered by IV infusion to patients with advanced 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 |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TAS266 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TAS266
- interventionNames
- Drug: TAS266
Primary outcomes (1)
- measure
- Frequency and characteristics of Dose limiting toxicities at each dose level
- timeFrame
- 2 years
Secondary outcomes (4)
- measure
- Type, frequency, and severity of AEs, changes in laboratory and clinical assessments
- timeFrame
- 2 years
- measure
- TAS266 serum concentrations and PK parameters: Cmax, Tmax, AUC0-tlast, Tlast, T1/2 and accumulation ratio of TAS266
- timeFrame
- 8 timepoints each for Cycles 1 and 2, prior to dosing on Day 1 of Cycles 3, 4, 5 and 6, at End of Treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of solid tumors * 18 years or older * ECOG performance status of 0, 1 or 2 * Adequate bone marrow, hepatic and renal function * Obtained written informed consent Exclusion Criteria: * Patients with primary CNS tumor or CNS tumor involvement. However patients with CNS metastases may be allowed if certain conditions are met. * Major surgery within 4 weeks before study treatment * Prior anaphylactic or other severe infusion reactions to human immunoglobulin or antibody formulations * Impaired cardiac functions * Previous hepatitis viral infection such as hepatitis B or hepatitis C * Diagnosis of HIV infection * Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.