A Study of TRK-950 in Patients With Advanced Solid Tumors
Study Details
Study Description
Brief Summary
The main purpose of this study is to determine the safety and tolerability of TRK-950 in patients with advanced solid tumors.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
This is an open-label phase I study of TRK-950 in patients with histologically and cytologically confirmed, metastatic or unresectable solid tumors who are refractory or intolerant to standard therapy or for whom no standard therapy exists. 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm : TRK-950 Solid Tumor TRK-950 will be administered intravenously on days 1, 8, 15, and 22 of a 28-day cycle. Two dose levels will be explored during this Arm. |
Biological: TRK-950
Intravenously over 60 minutes
|
Outcome Measures
Primary Outcome Measures
- Number of participants with dose-limiting toxicities (DLTs) [Up to Day 28]
Number of participants with DLTs will be determined.
- Number of participants with adverse events (AEs) [through study completion, an average of 1 year]
Number of participants with AEs will be assessed.
- Number of participants with serious adverse events (SAEs) [through study completion, an average of 1 year]
Number of participants with SAEs will be assessed.
Secondary Outcome Measures
- Area under the concentration curve (AUC) [through study completion, an average of 1 year]
- Maximum plasma concentration (Cmax) [through study completion, an average of 1 year]
- Time to maximum plasma concentration (Tmax) [through study completion, an average of 1 year]
- Terminal elimination half life (t1/2) [through study completion, an average of 1 year]
- Total body clearance (CL) [through study completion, an average of 1 year]
- Apparent volume of distribution (Vd) [through study completion, an average of 1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
-
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)
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Patients who are unwilling or unable to comply with the protocol specified procedures
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Cancer Center Hospital | Chuo Ku | Tokyo | Japan |
Sponsors and Collaborators
- Toray Industries, Inc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 950P1V03