Phase 1Completed
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
- Sponsor
- Toray Industries, Inc (Industry)
- Enrolment
- 138 enrolled
- 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
- TRK-950; TRK-950; TRK-950; Irinotecan; Leucovorin; 5-FU; Gemcitabine; Cisplatin; Carboplatin; Ramucirumab; Paclitaxel; Nivolumab
- Ages
- adults, older adults
- Registry
- NCT03872947
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Frequency of patients experiencing treatment emergent adverse events as assessed by CTCAE v5.0
- Frequency of patients experiencing adverse events of special interest (AESIs)
- Blood pressure
- Heart rate
History
Last registry update
Primary completion
Started
Registered