A Phase 1 Study Evaluating the Safety of TRK-950 in Patients With Advanced Solid Tumors
NCT ID: NCT02990481
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
38 participants
INTERVENTIONAL
2017-03-06
2019-09-16
Brief Summary
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2. To establish the dose of TRK-950 recommended for future phase 2 studies
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Detailed Description
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Once enrollment in Arm 1 was completed, two dose schedules will be evaluated in Arm 2 to determine the dosing schedule. Up to six (6) patients will be enrolled respectively.
In parallel, to determine anti-tumor activity up to twelve (12) patients will be enrolled in Arm 3.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Arm 1 - TRK-950
* Solid tumor
* TRK-950 (Three dose levels will be explored during Arm 1)
TRK-950
Intravenously over 60 minutes, on day 1, 8 and 15 of each cycle
Arm 2 - TRK-950
* Colon cancer
* TRK-950 (Low dose and High dose)
TRK-950
Low dose: intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle
High dose: intravenously over 60 minutes, on day 1 and 15 of each cycle
Arm 3 -TRK-950
* Cholangiocarcinomas
* TRK-950 (Low dose)
TRK-950
Low dose: Intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle
Interventions
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TRK-950
Intravenously over 60 minutes, on day 1, 8 and 15 of each cycle
TRK-950
Low dose: intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle
High dose: intravenously over 60 minutes, on day 1 and 15 of each cycle
TRK-950
Low dose: Intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Toray Industries, Inc
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic
Phoenix, Arizona, United States
HonorHealth Research Institute
Scottsdale, Arizona, United States
Centre Léon Bérard
Lyon, , France
Countries
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References
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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.
Other Identifiers
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950P1V01
Identifier Type: -
Identifier Source: org_study_id
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