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

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.

Study Overview

• Status: Terminated
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: TAS266

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center/University of South Florida Moffitt SC
  • Texas
    • San Antonio, Texas, United States, 789229
      • South Texas Accelerated Research Therapeutics START
  • Utah
    • Salt Lake City, Utah, United States, 84103
      • University of Utah / Huntsman Cancer Institute Huntsman UT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TAS266	Drug: TAS266; TAS266 IV infusions given weekly

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 Treatment Cycle = 28 days,) assuming maximum 6 cycles of treatment	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
Presence and concentration of anti-TAS266 antibodies		2 Years
Tumor response		2 Years

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CTAS266X2101 can be found on the Novartis Clinical Trial Results Website

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): September 1, 2012
• Study Completion (ACTUAL): September 1, 2012

Study Registration Dates

• First Submitted: February 1, 2012
• First Submitted That Met QC Criteria: February 6, 2012
• First Posted (ESTIMATE): February 8, 2012

Study Record Updates

• Last Update Posted (ACTUAL): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Biologic,; solid tumors,; Death Receptor 5 agonist,; caspase-8
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CTAS266X2101