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

Toray Industries

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Solid Tumor

Melanoma

Treatments

Biological: TRK-950

Drug: Nivolumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05423262

950P1V03

Details and patient eligibility

About

Part 1

• To determine the safety and tolerability of TRK-950 in patients with advanced solid tumors

Part 2

• To determine the safety and tolerability of TRK-950 in combination with nivolumab(NIVO) in patients with advanced solid tumors eligible for NIVO therapy

Part 3

• To determine the efficacy of TRK-950 in patients with advanced/recurrent unresectable melanoma, who received prior chemotherapy with dacarbazine(DTIC) and for whom no standard therapy exists

Full description

This is an open-label phase I/II study and consists of three parts. In 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 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 will receive two dose level of TRK-950 in combination with Nivolumab. In 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 will receive one dose level of TRK-950. 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.

Enrollment

49 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

49 participants in 4 patient groups

Part 1 : TRK-950

Experimental group

Description:

* 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.

Treatment:

Biological: TRK-950

Part 2 Cohort 1: TRK-950+Nivolumab

Experimental group

Description:

* Nivolumab-eligible solid tumor * Nivolumab will be administered intravenously on days 1 and 15 of a 28-day cycle. TRK-950 will be administered as an intravenously infusion on days 1, 8, 15 and 22. After the administration of Nivolumab on days 1 and 15, TRK-950 will be administered as an intravenously infusion.

Treatment:

Biological: TRK-950

Drug: Nivolumab

Biological: TRK-950

Part 2 Cohort 2: TRK-950+Nivolumab

Experimental group

Description:

* Nivolumab-eligible solid tumor * Nivolumab will be administered intravenously on days 1 and 15 of a 28-day cycle. TRK-950 will be administered as an intravenously infusion on days 1 and 15. After the administration of Nivolumab on days 1 and 15, TRK-950 will be administered as an intravenously infusion.

Treatment:

Biological: TRK-950

Drug: Nivolumab

Biological: TRK-950

Part 3: TRK-950

Experimental group

Description:

* Melanoma * TRK-950 will be administered intravenously on days 1, 8, 15, and 22 of a 28-day cycle.

Treatment:

Biological: TRK-950