A Study of TRK-950 in Patients With Advanced Solid Tumors

Summary

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

Eligibility

Inclusion Criteria:

* 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 Criteria:

* 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

Conditions3

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