NCT03872947

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

A Phase 1b, Multicenter Study to Determine the Dose, Safety, Efficacy and Pharmacokinetics of TRK-950 When Used in Combinations With Selected Anti-Cancer Treatment Regimens in Patients With Selected Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Toray Industries, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Solid Tumor
• Colorectal Cancer
• Cholangiocarcinoma
• Bladder Cancer
• Ovarian Cancer
• Gastric Cancer
• Palpable Subcutaneous Malignant Lesions
• Renal Cell Carcinoma
• Melanoma
• Epithelial Ovarian Cancer
• Primary Peritoneal Cancer
• Fallopian Tube Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-04-26
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2019-03-13
• Last updated: 2025-08-03

Locations

14 sites across 2 countries: United States, France

Regulatory

• FDA-regulated drug study