Solid Tumor, Melanoma
Conditions
Keywords
Nivolumab-eligible solid tumor, Melanoma
Brief 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
Detailed description
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.
Interventions
BIOLOGICALTRK-950
5 or 10 mg/kg administered intravenously over 60 minutes (weekly)
DRUGNivolumab
240 mg administered intravenously over 30 minutes (bi-weekly)
Sponsors
Toray Industries, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the concentration curve (AUC) of TRK-950 (Part 1 and 2) | through study completion, an average of 1 year | — |
| Maximum plasma concentration (Cmax) of TRK-950 (Part 1 and 2) | through study completion, an average of 1 year | — |
| Time to maximum plasma concentration (Tmax) of TRK-950 (Part 1 and 2) | through study completion, an average of 1 year | — |
| Terminal elimination half life (t1/2) of TRK-950 (Part 1 and 2) | through study completion, an average of 1 year | — |
| Total body clearance (CL) of TRK-950 (Part 1 and 2) | through study completion, an average of 1 year | — |
| Apparent volume of distribution (Vd) of TRK-950 (Part 1 and 2) | through study completion, an average of 1 year | — |
| Area under the concentration curve (AUC) of Nivolumab (Part 2 only) | through study completion, an average of 1 year | — |
| Overall survival (OS) (Part 3) | Up to approximately 12 months | Overall survival (OS) is defined as time from the first date of TRK-950 administration until the date of death due to any cause. |
| Progression-free survival (PFS) (Part 3) | Up to approximately 12 months | 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. |
| Best overall response (BOR) (Part 3) | Up to approximately 12 months | 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. |
| Disease control rate (DCR) (Part 3) | Up to approximately 12 months | 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. |
| Duration of response (DOR) (Part 3) | Up to approximately 12 months | 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. |
| Tumor change rate (Part 3) | Up to approximately 12 months | 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. |
Countries
Japan
Contacts
CONTACTToray Contact for Clinical Trial Information
Outcome results
None listed