A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

138

Participants

Timeline

Start Date

April 26, 2019

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Solid TumorColorectal CancerCholangiocarcinomaBladder CancerOvarian CancerGastric CancerPalpable Subcutaneous Malignant LesionsRenal Cell CarcinomaMelanomaEpithelial Ovarian CancerPrimary Peritoneal CancerFallopian Tube Cancer
Interventions
BIOLOGICAL

TRK-950

10 mg/kg administered intravenously over 60 minutes (weekly)

BIOLOGICAL

TRK-950

5 mg/kg administered intravenously over 60 minutes (weekly)

BIOLOGICAL

TRK-950

Treatment Phase: 20 mg/kg administered intravenously over 60 minutes (bi-weekly) Maintenance Phase: 30 mg/kg administered intravenously over 60 minutes (every 3 weeks)

DRUG

Irinotecan

Intravenously over 30 - 90 minutes

DRUG

Leucovorin

Intravenously over 30 - 90 minutes

DRUG

5-FU

Intravenously bolus and intravenously for two days

DRUG

Gemcitabine

Intravenously over 30 minutes

DRUG

Cisplatin

Intravenously over 60 minutes

DRUG

Carboplatin

Intravenously per package insert

DRUG

Ramucirumab

Intravenously over 60 minutes

DRUG

Paclitaxel

Intravenously

DRUG

Nivolumab

Intravenously over 30 minutes

DRUG

Pembrolizumab

Intravenously over 30 minutes

DRUG

Imiquimod Cream

Topically

DRUG

Bevacizumab

Intravenously over 90 minutes for the first dose, over 60 for the second dose and over 30 minutes for all subsequent doses

DRUG

PLD

Intravenously over 60 minutes

Trial Locations (14)

10016

Perlmutter Cancer Center at NYU Langone, New York

20176

Virginia Cancer Specialists, PC, Leesburg

53226

Medical College of Wisconsin, Milwaukee

69373

Centre Léon Bérard, Lyon

70121

Ochsner Clinic Foundation, New Orleans

75246

Texas Oncology, P.A. Baylor Charles A. Sammons Cancer Center, Dallas

76104

Texas Oncology - Downtown Fort Worth Cancer Center, Fort Worth

85258

HonorHealth Research Institute, Scottsdale

85711

AOA-HOPE, Tucson

90033

USC Norris Comprehensive Cancer Center, Los Angeles

92663

HOAG Memorial Hospital Presbyterian, Newport

97227

Northwest Cancer Specialists, Portland

97401

Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute and Research Center), Eugene

07960

Atlantic Health System, Morristown

All Listed Sponsors
lead

Toray Industries, Inc

INDUSTRY

NCT03872947 - A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors | Biotech Hunter | Biotech Hunter