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

NCT05423262 | Recruiting Phase 1

• 1 other identifier: 950P1V03
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 10

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

Conditions

Solid Tumor; Melanoma

Keywords

Nivolumab-eligible solid tumor; Melanoma

Outcome Measures

Primary Outcomes (5)

• Number of participants with dose-limiting toxicities (DLTs) (Part 1 and 2)

  Number of participants with DLTs will be determined.

  Up to Day 28

• Number of participants with adverse events (AEs) (Part 1 and 2)

  Number of participants with AEs will be assessed.

  through study completion, an average of 1 year

• Number of participants with adverse events of special interest (AESIs) (Part 1 and 2)

  Number of participants with AESIs will be assessed.

  through study completion, an average of 1 year

• Number of participants with serious adverse events (SAEs) (Part 1 and 2)

  Number of participants with SAEs will be assessed.

  through study completion, an average of 1 year

• Objective response rate (ORR) (Part 3)

  Objective response rate (ORR) is defined as the percentage of patients who achieved either complete response (CR) or partial response (PR) as assessed by independent central review (ICR) per RECIST Version 1.1.

  Up to approximately 12 months

Secondary Outcomes (13)

• Area under the concentration curve (AUC) of TRK-950 (Part 1 and 2)

  through study completion, an average of 1 year

• Maximum plasma concentration (Cmax) of TRK-950 (Part 1 and 2)

  through study completion, an average of 1 year

• Time to maximum plasma concentration (Tmax) of TRK-950 (Part 1 and 2)

  through study completion, an average of 1 year

• Terminal elimination half life (t1/2) of TRK-950 (Part 1 and 2)

  through study completion, an average of 1 year

• Total body clearance (CL) of TRK-950 (Part 1 and 2)

  through study completion, an average of 1 year

Study Arms (4)

Part 1 : TRK-950

EXPERIMENTAL

* 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

Part 2 Cohort 1: TRK-950+Nivolumab

EXPERIMENTAL

* 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.

Biological: TRK-950; Drug: Nivolumab

Part 2 Cohort 2: TRK-950+Nivolumab

EXPERIMENTAL

* 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.

Biological: TRK-950; Drug: Nivolumab

Part 3: TRK-950

EXPERIMENTAL

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

Biological: TRK-950

Interventions

TRK-950 BIOLOGICAL

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

Part 1 : TRK-950

Nivolumab DRUG

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Toray Industries, Inc: lead

Study Sites (10)

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

RECRUITING

National Hospital Organization Kyushu Cancer Center

Fukuoka, Fukuoka, 811-1395, Japan

RECRUITING

Sapporo Medical University Hospital

Sapporo, Hokkaido, 060-8543, Japan

RECRUITING

Kumamoto University Hospital

Kumamoto, Kumamoto, 860-8556, Japan

RECRUITING

Shinshu University Hospital

Matsumoto, Nagano, 390-8621, Japan

RECRUITING

Niigata Cancer Center Hospital

Niigata, Niigata, 951-8566, Japan

RECRUITING

Saitama Medical University International Medical Center

Hidaka, Saitama, 350-1298, Japan

RECRUITING

Shizuoka Cancer Center

Nagaizumi-chō, Shizuoka, 411-8777, Japan

RECRUITING

National Cancer Center Hospital

Chuo Ku, Tokyo, 104-0045, Japan

RECRUITING

Keio University Hospital

Shinjuku-Ku, Tokyo, 160-8582, Japan

RECRUITING

Related Publications (1)

• 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.

  PMID: 37082579 DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Toray Contact for Clinical Trial Information

CONTACT

+81467-32-9948; npdd-clinical.toray.mb@mail.toray

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 21, 2022
• Study Start: July 6, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (10)