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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01529307

Enrollment

Registered

2012-02-08

Start date

2012-06-30

Completion date

2012-09-30

Last updated

2020-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors

Keywords

Biologic,, solid tumors,, Death Receptor 5 agonist,, caspase-8

Brief summary

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.

Interventions

DRUGTAS266

TAS266 IV infusions given weekly

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Frequency and characteristics of Dose limiting toxicities at each dose level	2 years

Secondary

Measure	Time frame	Description
Type, frequency, and severity of AEs, changes in laboratory and clinical assessments	2 years	—
TAS266 serum concentrations and PK parameters: Cmax, Tmax, AUC0-tlast, Tlast, T1/2 and accumulation ratio of TAS266	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	1 Treatment Cycle = 28 days,) assuming maximum 6 cycles of treatment
Presence and concentration of anti-TAS266 antibodies	2 Years	—
Tumor response	2 Years	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026