Solid TumorPhase 1/2NCT05423262
A Study of TRK-950 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing TRK-950 and Nivolumab in people with Solid Tumor and Melanoma, run by Toray Industries, Inc at 10 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Melanoma
- What is being tested?
- TRK-950 and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 10 sitesJapan
- Study dates
- 6 Jul 2022to 31 Mar 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Japan10 sites, 10 recruiting
- Recruiting
National Cancer Center Hospital
Chuo Ku, Tokyo, 104-0045
Principal Investigator
- Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395
Principal Investigator
- Recruiting
Saitama Medical University International Medical Center
Hidaka, Saitama, 350-1298
Principal Investigator
- Recruiting
Kumamoto University Hospital
Kumamoto, Kumamoto, 860-8556
Principal Investigator
- Recruiting
Shinshu University Hospital
Matsumoto, Nagano, 390-8621
Principal Investigator
- Recruiting
Shizuoka Cancer Center
Nagaizumi-chō, Shizuoka, 411-8777
Principal Investigator
- Recruiting
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602
Principal Investigator
- Recruiting
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566
Principal Investigator
- Recruiting
Sapporo Medical University Hospital
Sapporo, Hokkaido, 060-8543
Principal Investigator
- Recruiting
Keio University Hospital
Shinjuku-Ku, Tokyo, 160-8582
Principal Investigator
About this study
Official title: A Phase I/II Study of TRK-950 in Patients With Advanced Solid Tumors
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
Read the 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
- Being tested
- TRK-950, Nivolumab
- Keywords
- Nivolumab-eligible solid tumor, Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRK-950Biological
5 or 10 mg/kg administered intravenously over 60 minutes (weekly)
TRK-950Biological
10 mg/kg administered intravenously over 60 minutes (weekly)
TRK-950Biological
20 mg/kg administered intravenously over 60 minutes (bi-weekly)
NivolumabDrug
240 mg administered intravenously over 30 minutes (bi-weekly)
TRK-950Biological
10 mg/kg administered Intravenously over 60 minutes (weekly)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Biological: TRK-950 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose-limiting toxicities (DLTs) (Part 1 and 2)
Number of participants with DLTs will be determined.
Measured: Up to Day 28
Number of participants with adverse events (AEs) (Part 1 and 2)
Number of participants with AEs will be assessed.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 12 months
Secondary outcomes (13)
Area under the concentration curve (AUC) of TRK-950 (Part 1 and 2)
Measured: through study completion, an average of 1 year
Maximum plasma concentration (Cmax) of TRK-950 (Part 1 and 2)
Measured: through study completion, an average of 1 year
Time to maximum plasma concentration (Tmax) of TRK-950 (Part 1 and 2)
Measured: through study completion, an average of 1 year
Terminal elimination half life (t1/2) of TRK-950 (Part 1 and 2)
Measured: through study completion, an average of 1 year
Total body clearance (CL) of TRK-950 (Part 1 and 2)
Measured: through study completion, an average of 1 year
Apparent volume of distribution (Vd) of TRK-950 (Part 1 and 2)
Measured: through study completion, an average of 1 year
Area under the concentration curve (AUC) of Nivolumab (Part 2 only)
Measured: through study completion, an average of 1 year
Overall survival (OS) (Part 3)
Overall survival (OS) is defined as time from the first date of TRK-950 administration until the date of death due to any cause.
Measured: Up to approximately 12 months
Progression-free survival (PFS) (Part 3)
Progression-free survival (PFS) is defined as time from the first date of TRK-950 administration until progression per RECIST Version 1.1, or death due to any cause.
Measured: Up to approximately 12 months
Best overall response (BOR) (Part 3)
Best overall response (BOR) is defined as the best response among all responses at each time point from the first date of TRK-950 administration until progression per RECIST Version 1.1.
Measured: Up to approximately 12 months
Disease control rate (DCR) (Part 3)
Disease control rate (DCR) is defined as the percentage of patients with BOR of CR or PR or stable disease (SD) per RECIST Version 1.1.
Measured: Up to approximately 12 months
Duration of response (DOR) (Part 3)
Duration of response (DOR) is defined as the duration between the date of first documented response (CR or PR) and the date of progression per RECIST Version 1.1, or death due to any cause.
Measured: Up to approximately 12 months
Tumor change rate (Part 3)
Tumor change rate is defined as the percentage change in the sum of the longest diameters of target lesions, as assessed per RECIST Version 1.1, compared to baseline obtained at screening.
Measured: Up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start6 Jul 2022
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toray Industries, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423262
- Sponsor's protocol ID
- 950P1V03
- Status last verified
- Oct 2026
- First submitted
- 14 Jun 2022
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41979863Okano 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.
PubMed 37082579