Clinical trial · Interventional
A Phase 1 Study Evaluating the Safety of TRK-950 in Patients With Advanced Solid Tumors
A Phase 1, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of TRK-950 Given Intravenously in Patients With Advanced Solid Tumors
NCT02990481CI-TRIAL-00088616completedPhase 1ClinicalTrials.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)
1. To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs) of TRK-950 as single agent 2. To establish the dose of TRK-950 recommended for future phase 2 studies
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Locally Advanced or Metastatic Solid Carcinomas | Colon Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TRK-950 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm 1 - TRK-950
- description
- * Solid tumor * TRK-950 (Three dose levels will be explored during Arm 1)
- interventionNames
- Biological: TRK-950
- type
- EXPERIMENTAL
- label
- Arm 2 - TRK-950
- description
- * Colon cancer * TRK-950 (Low dose and High dose)
- interventionNames
- Biological: TRK-950
- type
- EXPERIMENTAL
- label
- Arm 3 -TRK-950
- description
- * Cholangiocarcinomas * TRK-950 (Low dose)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically confirmed locally advanced or metastatic solid carcinomas in Arm 1 * Patients with histologically confirmed locally advanced or metastatic colon cancer in Arm 2 * Patients with histologically confirmed locally advanced or metastatic cholangiocarcinomas in Arm 3 * Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy or not amendable to a curative treatment * Measurable disease per RECIST 1.1 (primary or metastases) Exclusion Criteria: * New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG * Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy * Pregnant or nursing women * Treatment with radiation therapy, surgery, chemotherapy, immunotherapy, or investigational therapy within four weeks prior to study entry * Unwillingness or inability to comply with procedures required in this protocol * Known active infection with HIV, hepatitis B, hepatitis C * Symptomatic brain metastases * Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor * Patients who are currently receiving any other investigational agent
References
Publications (1)
- 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