Part 1, 2: Solid tumors Part 3: Melanoma
Conditions
Interventions
Part 1
- Investigational material: TRK-950
5 or 10 mg/kg administered Intravenously over 60 minutes (weekly)
Part 2 Cohort 1
- Investigational material: TRK-950
10 mg/kg administered Intravenously ov
Sponsors
Mori Yoshitaka
Eligibility
Sex/Gender
All
Inclusion 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 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
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 |
|---|---|
| Part 1 and 2 - Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: Up to Day 28 ] Number of participants with DLTs will be determined. - Number of participants with adverse events (AEs) [ Time Frame: 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) [ Time Frame: through study completion, an average of 1 year] Number of participants with AESIs will be assessed. - Number of participants with serious adverse events (SAEs) [ Time Frame: through study completion, an average of 1 year ] Number of participants with SAEs will be assessed. Part 3 - The percentage of patients who achieved either complete response (CR) or partial response (PR) as assessed by independent central review (ICR) (overall response rate: ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 3 - Overall survival (OS) - Progression-free survival (PFS) - Best overall response (BOR) - Disease control rate (DCR) - Duration of response (DOR) - Tumor change rate | — |
Contacts
Public ContactYoshitaka Mori
Toray Industries, Inc.
Outcome results
None listed