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

NCT ID: NCT05423262

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-06
• Study Completion Date: 2027-12-31

Brief Summary

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

Detailed 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.

Conditions

Solid Tumor; Melanoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1 : 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.

Group Type: EXPERIMENTAL

TRK-950

Intervention Type: BIOLOGICAL

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

Part 2 Cohort 1: TRK-950+Nivolumab

• 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.

Group Type: EXPERIMENTAL

TRK-950

Intervention Type: BIOLOGICAL

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

Nivolumab

Intervention Type: DRUG

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

Part 2 Cohort 2: TRK-950+Nivolumab

• 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.

Group Type: EXPERIMENTAL

TRK-950

Intervention Type: BIOLOGICAL

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

Nivolumab

Intervention Type: DRUG

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

Part 3: TRK-950

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

Group Type: EXPERIMENTAL

TRK-950

Intervention Type: BIOLOGICAL

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

Interventions

TRK-950

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

Intervention Type: BIOLOGICAL

TRK-950

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

Intervention Type: BIOLOGICAL

TRK-950

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

Intervention Type: BIOLOGICAL

Nivolumab

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

Intervention Type: DRUG

TRK-950

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

Intervention Type: BIOLOGICAL

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.
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Toray Industries, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Site Status: RECRUITING

Kumamoto University Hospital

Kumamoto, Kumamoto, Japan

Site Status: RECRUITING

Shinshu University Hospital

Matsumoto, Nagano, Japan

Site Status: RECRUITING

Niigata Cancer Center Hospital

Niigata, Niigata, Japan

Site Status: RECRUITING

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

Site Status: RECRUITING

National Cancer Center Hospital

Chuo Ku, Tokyo, Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Toray Contact for Clinical Trial Information

Role: CONTACT

npdd-clinical.toray.mb@mail.toray

+81467-32-9948

Facility Contacts

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

References

Okano F, Saito T, Minamida Y, Kobayashi S, Ido T, Miyauchi Y, Wasai U, Akazawa D, Kume M, Ishibashi M, Jiang K, Aicher A, Heeschen C, Yonehara T. Identification of Membrane-expressed CAPRIN-1 as a Novel and Universal Cancer Target, and Generation of a Therapeutic Anti-CAPRIN-1 Antibody TRK-950. Cancer Res Commun. 2023 Apr 18;3(4):640-658. doi: 10.1158/2767-9764.CRC-22-0310. eCollection 2023 Apr.

Reference Type: DERIVED

PMID: 37082579 (View on PubMed)

Other Identifiers

950P1V03

Identifier Type: -

Identifier Source: org_study_id