TRK-950: 5 or 10 mg/kg administered intravenously over 60 minutes (weekly)
TRK-950: 10 mg/kg administered intravenously over 60 minutes (weekly)
TRK-950: 20 mg/kg administered intravenously over 60 minutes (bi-weekly)
Nivolumab: 240 mg administered intravenously over 30 minutes (bi-weekly)
TRK-950: 10 mg/kg administered Intravenously over 60 minutes (weekly)
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Number of participants with dose-limiting toxicities (DLTs) (Part 1 and 2) — Up to Day 28 Number of participants with DLTs will be determined.
Number of participants with adverse events (AEs) (Part 1 and 2) — through study completion, an average of 1 year Number of participants with AEs will be assessed.
Number of participants with adverse events of special interest (AESIs) (Part 1 and 2) — through study completion, an average of 1 year Number of participants with AESIs will be assessed.
Number of participants with serious adverse events (SAEs) (Part 1 and 2) — through study completion, an average of 1 year Number of participants with SAEs will be assessed.
Objective response rate (ORR) (Part 3) — Up to approximately 12 months Objective response rate (ORR) is defined as the percentage of patients who achieved either complete response (CR) or partial response (PR) as assessed by independent central review (ICR) per RECIST Version 1.1.
Trial sites (10)
Facility
City
Region
Status
Nagoya City University Hospital
Nagoya
Aichi-ken
Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka
Fukuoka
Recruiting
Sapporo Medical University Hospital
Sapporo
Hokkaido
Recruiting
Kumamoto University Hospital
Kumamoto
Kumamoto
Recruiting
Shinshu University Hospital
Matsumoto
Nagano
Recruiting
Niigata Cancer Center Hospital
Niigata
Niigata
Recruiting
Saitama Medical University International Medical Center
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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