Clinical trial

A Phase I Study of TRK-950 in Patients With Advanced Solid Tumors

Name

950P1V03

Description

The main purpose of this study is to determine the safety and tolerability of TRK-950 alone and in combination with Nivolumab in patients with advanced solid tumors

Trial arms

Trial start

2022-07-06

Estimated PCD

2025-02-01

Trial end

2025-02-01

Status

Recruiting

Phase

Early phase I

Treatment

TRK-950

5 or 10 mg/kg administered intravenously over 60 minutes (weekly)

Arms:

Part 1 : TRK-950

TRK-950

10 mg/kg administered intravenously over 60 minutes (weekly)

Arms:

Part 2 Cohort 1: TRK-950+Nivolumab

TRK-950

20 mg/kg administered intravenously over 60 minutes (bi-weekly)

Arms:

Part 2 Cohort 2: TRK-950+Nivolumab

Nivolumab

240 mg administered intravenously over 30 minutes (bi-weekly)

Arms:

Part 2 Cohort 1: TRK-950+Nivolumab, Part 2 Cohort 2: TRK-950+Nivolumab

Size

Primary endpoint

Number of participants with dose-limiting toxicities (DLTs)

Up to Day 28

Number of participants with adverse events (AEs)

through study completion, an average of 1 year

Number of participants with adverse events of special interest (AESIs)

through study completion, an average of 1 year

Number of participants with serious adverse events (SAEs)

through study completion, an average of 1 year

Eligibility 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. * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 19, 'type': 'ESTIMATED'}}

Updated at

2024-02-05

1 organization

2 products

1 indication

Organization

Product

Indication

Product