A phase I/II study of TRK-950 in patients with advanced solid tumors
A study of TRK-950 in patients with advanced solid tumors
Mori Yoshitaka
Toray Industries, Inc.
10-1, Tebiro 6-chome, Kamakura, Kanagawa
+81-467-32-9358
npdd-clinical.toray.mb@mail.toray
Mori Yoshitaka
Toray Industries, Inc.
10-1, Tebiro 6-chome, Kamakura, Kanagawa
+81-467-32-9358
npdd-clinical.toray.mb@mail.toray
Recruiting
July. 04, 2022
July. 06, 2022
49
Interventional
single arm study
open(masking not used)
uncontrolled control
single assignment
treatment purpose
- 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)
- 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
18age old over
No limit
Both
Part 1, 2: Solid tumors
Part 3: Melanoma
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 over 60 minutes (weekly)
- Concomitant material: Nivolumab
240 mg administered Intravenously over >=30 minutes (bi-weekly)
Part 2 Cohort 2
- Investigational material: TRK-950
20 mg/kg administered Intravenously over 60 minutes (bi-weekly)
- Concomitant material: Nivolumab
240 mg administered Intravenously over >=30 minutes (bi-weekly)
Part 3
- Investigational material: TRK-950
10 mg/kg administered Intravenously over 60 minutes (weekly)
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)
Part 3
- Overall survival (OS)
- Progression-free survival (PFS)
- Best overall response (BOR)
- Disease control rate (DCR)
- Duration of response (DOR)
- Tumor change rate
