A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors
NCT03872947 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 138
Last updated 2025-08-03
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.
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
- 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
-
Intravenously over 30 - 90 minutes
- DRUG
-
Intravenously over 30 - 90 minutes
- DRUG
-
Intravenously bolus and intravenously for two days
- DRUG
-
Intravenously over 30 minutes
- DRUG
-
Intravenously over 60 minutes
- DRUG
-
Intravenously per package insert
- DRUG
-
Intravenously over 60 minutes
- DRUG
-
Intravenously
- DRUG
-
Intravenously over 30 minutes
- DRUG
-
Intravenously over 30 minutes
- DRUG
-
Imiquimod Cream
Topically
- DRUG
-
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
Sponsors & Collaborators
-
Toray Industries, Inc
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-04-26
- Primary Completion
- 2026-06-30
- Completion
- 2026-06-30
- FDA Drug
- Yes
Countries
- United States
- France
Study Locations
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