A Study of TRK-950 in Patients With Advanced Solid Tumors
Recruiting
Phase 1Phase 2Interventional Study
Solid TumorMelanoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
49 (estimated)
Sponsor
Toray Industries, Inc · Industry
Who this trial is looking for
Think this trial could be right for you?
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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 chemother…
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
Trial Locations
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Eligibility Criteria
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 lo…
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
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