The main purpose of this study is to establish the safety and the recommended dose of TRK-950 in combination with FOLFIRI, Gemcitabine / Cisplatin, Gemcitabine / Carboplatin, Ramucirumab / Paclitaxel, PD1 inhibitors (Nivolumab or Pembrolizumab), and Imiquimod Cream, Bevacizumab, Gemcitabine / Carboplatin / Bevacizumab, Pegylated liposomal doxorubicin (PLD), Carboplatin / PLD / Bevacizumab and Paclitaxel for selected advanced solid tumors.
This study is an open-label, Phase 1b study evaluating TRK-950 in combination with 1) FOLFIRI or 2) Gemcitabine / Cisplatin or 3) Gemcitabine / Carboplatin or 4) Ramucirumab/Paclitaxel or 5) PD1 inhibitors (Nivolumab or Pembrolizumab) or 6) Imiquimod Cream for subcutaneous lesions 7) Bevacizumab 8) Gemcitabine / Carboplatin / Bevacizumab, 9)PLD, 10) Carboplatin / PLD / Bevacizumab or 11) Paclitaxel in Patients with Selected Advanced Solid Tumors. The objectives of this study are to determine the safety, tolerability, MTD, recommended Phase 2 dose (RP2D), PK, and preliminary anti-tumor activity of TRK-950 when used in combination with other treatment regimens.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
138
10 mg/kg administered intravenously over 60 minutes (weekly)
5 mg/kg administered intravenously over 60 minutes (weekly)
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)
Intravenously over 30 - 90 minutes
Intravenously over 30 - 90 minutes
Intravenously bolus and intravenously for two days
Intravenously over 30 minutes
Intravenously over 60 minutes
Intravenously per package insert
Intravenously over 60 minutes
Intravenously
Intravenously over 30 minutes
Intravenously over 30 minutes
Topically
Intravenously over 90 minutes for the first dose, over 60 for the second dose and over 30 minutes for all subsequent doses
Intravenously over 60 minutes
HonorHealth Research Institute
Scottsdale, Arizona, United States
AOA-HOPE
Tucson, Arizona, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
HOAG Memorial Hospital Presbyterian
Newport, California, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Atlantic Health System
Morristown, New Jersey, United States
Perlmutter Cancer Center at NYU Langone
New York, New York, United States
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute and Research Center)
Eugene, Oregon, United States
Northwest Cancer Specialists
Portland, Oregon, United States
Texas Oncology, P.A. Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
...and 4 more locations
Frequency of patients experiencing treatment emergent adverse events as assessed by CTCAE v5.0
Time frame: through study completion, an average of 1 year
Frequency of patients experiencing adverse events of special interest (AESIs)
Time frame: through study completion, an average of 1 year
Blood pressure
mmHg
Time frame: through study completion, an average of 1 year
Heart rate
bpm
Time frame: through study completion, an average of 1 year
Respiratory rate
bpm
Time frame: through study completion, an average of 1 year
Temperature
°F or °C
Time frame: through study completion, an average of 1 year
Weight
lbs/kg
Time frame: through study completion, an average of 1 year
Height
inches/cm
Time frame: through study completion, an average of 1 year
Performance status using Karnofsky performance status criteria
Time frame: through study completion, an average of 1 year
QTc interval determined from 12-lead Electrocardiogram
msec
Time frame: through study completion, an average of 1 year
QRS interval determined from 12-lead Electrocardiogram
msec
Time frame: through study completion, an average of 1 year
Frequency of patients with laboratory abnormalities (Complete Blood Count, Coagulation, Urinalysis and Serum Chemistry)
Time frame: through study completion, an average of 1 year
Overall response rate (ORR)
Time frame: through study completion, an average of 1 year
Disease Control Rate (DCR)
Time frame: through study completion, an average of 1 year
Serum concentration of TRK-950
Time frame: through study completion, an average of 1 year
Plasma concentration of Gemcitabine for the first six patients in Arm K
Time frame: At the beginning of Cycle 1 and Cycle 4 (each cycle is 21 days)
Plasma concentration of Carboplatin for the first six patients in Arm K
Time frame: At the beginning of Cycle 1 and Cycle 4 (each cycle is 21 days)
Serum concentration of Bevacizumab for the first six patients in Arm K
Time frame: At the beginning of Cycle 1, Cycle 2, Cycle 4 and Cycle 5 (each cycle is 21 days)
Plasma concentration of PLD for the first six patients in Arm O
Time frame: At the beginning and middle of Cycle 1 and Cycle 3 (each cycle is 28 days)
Serum concentration of Ramucirumab for the first six patients in Arm Q
Time frame: At the beginning and middle of Cycle 1 and Cycle 4 (each cycle is 28 days)
Plasma concentration of Paclitaxel for the first six patients in Arm Q
Time frame: At the beginning of Cycle 1 and Cycle 4 (each cycle is 28 days)
Serum concentration of Bevacizumab for the first six patients in Arm R
Time frame: At the beginning and middle of Cycle 1 and Cycle 4 (each cycle is 28 days)
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