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
This is an open-label phase I/II study and consists of three parts. In 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 will receive two dose level of TRK-950. In 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 will receive two dose level of TRK-950 in combination with Nivolumab. In 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 will receive one dose level of TRK-950. The objectives of this study are to determine the safety, tolerability, pharmacokinetic (PK) profile and the incidence of the development of anti-drug antibodies (ADA) and neutralizing antibodies (NAb) against TRK-950.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
RECRUITINGNational Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, Japan
RECRUITINGNumber of participants with dose-limiting toxicities (DLTs) (Part 1 and 2)
Number of participants with DLTs will be determined.
Time frame: Up to Day 28
Number of participants with adverse events (AEs) (Part 1 and 2)
Number of participants with AEs will be assessed.
Time frame: through study completion, an average of 1 year
Number of participants with adverse events of special interest (AESIs) (Part 1 and 2)
Number of participants with AESIs will be assessed.
Time frame: through study completion, an average of 1 year
Number of participants with serious adverse events (SAEs) (Part 1 and 2)
Number of participants with SAEs will be assessed.
Time frame: through study completion, an average of 1 year
Objective response rate (ORR) (Part 3)
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.
Time frame: Up to approximately 12 months
Area under the concentration curve (AUC) of TRK-950 (Part 1 and 2)
Time frame: through study completion, an average of 1 year
Maximum plasma concentration (Cmax) of TRK-950 (Part 1 and 2)
Time frame: through study completion, an average of 1 year
Time to maximum plasma concentration (Tmax) of TRK-950 (Part 1 and 2)
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240 mg administered intravenously over 30 minutes (bi-weekly)
10 mg/kg administered Intravenously over 60 minutes (weekly)
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan
RECRUITINGKumamoto University Hospital
Kumamoto, Kumamoto, Japan
RECRUITINGShinshu University Hospital
Matsumoto, Nagano, Japan
RECRUITINGNiigata Cancer Center Hospital
Niigata, Niigata, Japan
RECRUITINGSaitama Medical University International Medical Center
Hidaka, Saitama, Japan
RECRUITINGShizuoka Cancer Center
Nagaizumi-chō, Shizuoka, Japan
RECRUITINGNational Cancer Center Hospital
Chuo Ku, Tokyo, Japan
RECRUITINGKeio University Hospital
Shinjuku-Ku, Tokyo, Japan
RECRUITINGTime frame: through study completion, an average of 1 year
Terminal elimination half life (t1/2) of TRK-950 (Part 1 and 2)
Time frame: through study completion, an average of 1 year
Total body clearance (CL) of TRK-950 (Part 1 and 2)
Time frame: through study completion, an average of 1 year
Apparent volume of distribution (Vd) of TRK-950 (Part 1 and 2)
Time frame: through study completion, an average of 1 year
Area under the concentration curve (AUC) of Nivolumab (Part 2 only)
Time frame: through study completion, an average of 1 year
Overall survival (OS) (Part 3)
Overall survival (OS) is defined as time from the first date of TRK-950 administration until the date of death due to any cause.
Time frame: Up to approximately 12 months
Progression-free survival (PFS) (Part 3)
Progression-free survival (PFS) is defined as time from the first date of TRK-950 administration until progression per RECIST Version 1.1, or death due to any cause.
Time frame: Up to approximately 12 months
Best overall response (BOR) (Part 3)
Best overall response (BOR) is defined as the best response among all responses at each time point from the first date of TRK-950 administration until progression per RECIST Version 1.1.
Time frame: Up to approximately 12 months
Disease control rate (DCR) (Part 3)
Disease control rate (DCR) is defined as the percentage of patients with BOR of CR or PR or stable disease (SD) per RECIST Version 1.1.
Time frame: Up to approximately 12 months
Duration of response (DOR) (Part 3)
Duration of response (DOR) is defined as the duration between the date of first documented response (CR or PR) and the date of progression per RECIST Version 1.1, or death due to any cause.
Time frame: Up to approximately 12 months
Tumor change rate (Part 3)
Tumor change rate is defined as the percentage change in the sum of the longest diameters of target lesions, as assessed per RECIST Version 1.1, compared to baseline obtained at screening.
Time frame: Up to approximately 12 months