Clinical trial NCT05423262: A Study of TRK-950 in Patients with Advanced Solid Tumors
Official title: A Phase I Study of TRK-950 in Patients with Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Solid Tumor
Keywords: Nivolumab-eligible solid tumor
Lead sponsor: Toray Industries, Inc
Sponsor class: INDUSTRY
First posted: 2022-06-21
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: This is an open-label phase I study and consists of two parts. In the 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 the Part 2, patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who are eligible for standard therapy with Nivolumab 240 mg alone administered at 2-week intervals will receive two dose level of TRK-950 in combination with Nivolumab. 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.

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

Primary outcomes:
measure: Number of participants with dose-limiting toxicities (DLTs)
timeFrame: Up to Day 28
measure: Number of participants with adverse events (AEs)
timeFrame: through study completion, an average of 1 year
measure: Number of participants with adverse events of special interest (AESIs)
timeFrame: through study completion, an average of 1 year
measure: Number of participants with serious adverse events (SAEs)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Area under the concentration curve (AUC) of TRK-950
timeFrame: through study completion, an average of 1 year
measure: Maximum plasma concentration (Cmax) of TRK-950
timeFrame: through study completion, an average of 1 year
measure: Time to maximum plasma concentration (Tmax) of TRK-950
timeFrame: through study completion, an average of 1 year
measure: Terminal elimination half life (t1/2) of TRK-950
timeFrame: through study completion, an average of 1 year
measure: Total body clearance (CL) of TRK-950
timeFrame: through study completion, an average of 1 year
measure: Apparent volume of distribution (Vd) of TRK-950
timeFrame: through study completion, an average of 1 year
measure: Area under the concentration curve (AUC) of Nivolumab (Part 2 only)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Chuo Ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
Study officials:
References: