A Study of TRK-950 in Patients With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TRK-950, TRK-950, TRK-950, Nivolumab.
- Who it may be relevant to
- Registry conditions: Solid Tumor, Melanoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I/II Study of TRK-950 in Patients With Advanced Solid Tumors
Overview
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.
Interventions
- Biological TRK-950
5 or 10 mg/kg administered intravenously over 60 minutes (weekly) - Biological TRK-950
10 mg/kg administered intravenously over 60 minutes (weekly) - Biological TRK-950
20 mg/kg administered intravenously over 60 minutes (bi-weekly) - Drug Nivolumab
240 mg administered intravenously over 30 minutes (bi-weekly) - Biological TRK-950
10 mg/kg administered Intravenously over 60 minutes (weekly)
Primary outcome measures
- Number of participants with dose-limiting toxicities (DLTs) (Part 1 and 2) [Time frame: Up to Day 28]
- Number of participants with adverse events (AEs) (Part 1 and 2) [Time frame: through study completion, an average of 1 year]
- Number of participants with adverse events of special interest (AESIs) (Part 1 and 2) [Time frame: through study completion, an average of 1 year]
- Number of participants with serious adverse events (SAEs) (Part 1 and 2) [Time frame: through study completion, an average of 1 year]
- Objective response rate (ORR) (Part 3) [Time frame: Up to approximately 12 months]
Secondary outcome measures (12)
- Area under the concentration curve (AUC) of TRK-950 (Part 1 and 2) [Time frame: through study completion, an average of 1 year]
- Maximum plasma concentration (Cmax) of TRK-950 (Part 1 and 2) [Time frame: through study completion, an average of 1 year]
- Time to maximum plasma concentration (Tmax) of TRK-950 (Part 1 and 2) [Time frame: through study completion, an average of 1 year]
- Terminal elimination half life (t1/2) of TRK-950 (Part 1 and 2) [Time frame: through study completion, an average of 1 year]
- Total body clearance (CL) of TRK-950 (Part 1 and 2) [Time frame: through study completion, an average of 1 year]
- Apparent volume of distribution (Vd) of TRK-950 (Part 1 and 2) [Time frame: through study completion, an average of 1 year]
- Area under the concentration curve (AUC) of Nivolumab (Part 2 only) [Time frame: through study completion, an average of 1 year]
- Overall survival (OS) (Part 3) [Time frame: Up to approximately 12 months]
- Progression-free survival (PFS) (Part 3) [Time frame: Up to approximately 12 months]
- Best overall response (BOR) (Part 3) [Time frame: Up to approximately 12 months]
- Disease control rate (DCR) (Part 3) [Time frame: Up to approximately 12 months]
- Duration of response (DOR) (Part 3) [Time frame: Up to approximately 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 10 centers
- Nagoya City University Hospital — Nagoya
- National Hospital Organization Kyushu Cancer Center — Fukuoka
- Sapporo Medical University Hospital — Sapporo
- Kumamoto University Hospital — Kumamoto
- Shinshu University Hospital — Matsumoto
- Niigata Cancer Center Hospital — Niigata
- Saitama Medical University International Medical Center — Hidaka
- Shizuoka Cancer Center — Nagaizumi-chō
- … and 2 more centers
Publications
- Koyama T, Yonemori K, Sato J, Katsuya Y, Okada M, Yoshida T, Okano F, Yamamoto N. A phase I study of TRK-950, an Anti-CAPRIN-1 antibody, as monotherapy and in combination with nivolumab in Japanese patients with advanced solid tumors. Invest New Drugs. 2026 Apr 14. doi: 10.1007/s10637-026-01609-z. Online ahead of print. PMID 41979863
- 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
Identifiers
NCT: NCT05423262 · 950P1V03