Clinical trial · Interventional
A Study of TRK-950 in Patients With Advanced Solid Tumors
A Phase I/II Study of TRK-950 in Patients With Advanced Solid Tumors
NCT05423262CI-TRIAL-00107830recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab | Drug | Nivolumab | ALIAS |
| TRK-950 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Part 1 : TRK-950
- 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.
- interventionNames
- Biological: TRK-950
- type
- EXPERIMENTAL
- label
- Part 2 Cohort 1: TRK-950+Nivolumab
- 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.
- interventionNames
- Biological: TRK-950
- Drug: Nivolumab
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDKoyama 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
- DERIVEDOkano 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