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
1 other identifier
interventional
38
2 countries
3
Brief Summary
- 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2017
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2016
CompletedFirst Posted
Study publicly available on registry
December 13, 2016
CompletedStudy Start
First participant enrolled
March 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 16, 2019
CompletedApril 16, 2025
November 1, 2024
2.5 years
November 29, 2016
April 13, 2025
Conditions
Outcome Measures
Primary Outcomes (11)
Adverse event
through study completion, an average of 1 year
CTCAE version 4.03
through study completion, an average of 1 year
Blood pressure (mmHg)
through study completion, an average of 1 year
Heart rate (bpm)
through study completion, an average of 1 year
Respiratory rate (bpm)
through study completion, an average of 1 year
Temperature (°F or °C)
through study completion, an average of 1 year
Weight (lbs/kg)
through study completion, an average of 1 year
Height (inches/cm)
through study completion, an average of 1 year
Karnofsky performance status
through study completion, an average of 1 year
Electrocardiogram
through study completion, an average of 1 year
Clinical laboratory tests
through study completion, an average of 1 year
Secondary Outcomes (10)
Area under the concentration curve(AUC)
through study completion, an average of 1 year
Maximum plasma concentration(Cmax)
through study completion, an average of 1 year
Time to maximum plasma concentration(Tmax)
through study completion, an average of 1 year
Terminal elimination half life(t1/2)
through study completion, an average of 1 year
Total body clearance(CL)
through study completion, an average of 1 year
- +5 more secondary outcomes
Study Arms (3)
Arm 1 - TRK-950
EXPERIMENTAL* Solid tumor * TRK-950 (Three dose levels will be explored during Arm 1)
Arm 2 - TRK-950
EXPERIMENTAL* Colon cancer * TRK-950 (Low dose and High dose)
Arm 3 -TRK-950
EXPERIMENTAL* Cholangiocarcinomas * TRK-950 (Low dose)
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Mayo Clinic
Phoenix, Arizona, 85054, United States
HonorHealth Research Institute
Scottsdale, Arizona, 85258, United States
Centre Léon Bérard
Lyon, 69373, France
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: 37082579DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2016
First Posted
December 13, 2016
Study Start
March 6, 2017
Primary Completion
September 16, 2019
Study Completion
September 16, 2019
Last Updated
April 16, 2025
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share