First in Human Trial of TAS266 in Patients With Advanced Solid Tumors

Novartis

Status and phase: Terminated; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: TAS266

Study type: Interventional

Funder types: Industry

Identifiers

NCT01529307

CTAS266X2101

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

TAS266

Experimental group

Treatment:

Drug: TAS266