A Study of TRK-950 in Patients With Advanced Solid Tumors
About this study
Part 1 • To determine the safety and tolerability of TRK-950 in patients with advanced solid tumors Part 2 • To determine the safety and tolerability of TRK-950 in combination with nivolumab(NIVO) in patients with advanced solid tumors eligible for NIVO therapy Part 3 • To determine the efficacy of TRK-950 in patients with advanced/recurrent unresectable melanoma, who received prior chemotherapy with dacarbazine(DTIC) and for whom no standard therapy exists
- Condition
- Solid Tumor, Melanoma
- Tested
- TRK-950, TRK-950, TRK-950, Nivolumab, TRK-950
- Sponsor
- Toray Industries, Inc
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 9
- Minimum age: 18 years
- Study condition: Solid Tumor, Melanoma
- Part 1: Patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who have been refractory or intolerant to standard therapies or for whom no standard therapy exists.
- Part 2: Patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who are eligible for standard therapy with NIVO 240 mg alone administered at 2-week intervals.
- Part 3: Patients with histologically confirmed locally advanced unresectable or metastatic melanoma (excluding uveal melanoma), who received prior chemotherapy with DTIC and for whom no standard therapy exists
- Patients with life expectancy of at least 3 months after the start of study drug administration
- Patients aged \>=18 years at the time of consent
- Patients who are able to provide written consent in person to be a subject of this study
- A negative pregnancy test before enrollment (if female of childbearing potential)
Exclusion 7
- Patients with active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
- Pregnant women (including those who are considered possibly pregnant based on history taking, etc. by physician) or breastfeeding women (interrupting breastfeeding to enroll is also not allowed)
- Patients who are unwilling or unable to comply with the protocol specified procedures
- Patients who are positive for human immunodeficiency virus (HIV) antibody
- Patients who meet any of the following conditions on hepatitis B virus (HBV) and hepatitis C virus (HCV) testing
- Patients who are positive for hepatitis B surface antigen (HBsAg)
- Patients who are positive for HCV RNA
Where
10 sites, 10 recruiting
National Cancer Center Hospital
Chuo Ku, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, Japan
Shinshu University Hospital
Matsumoto, Nagano, Japan
Shizuoka Cancer Center
Nagaizumi-chō, Shizuoka, Japan
and 4 more sites on ClinicalTrials.gov
Contact
-
Toray Contact for Clinical Trial Information
+81467-32-9948 npdd-clinical.toray.mb@mail.toray
Potential match only. Final eligibility is determined by the study team.