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This study is a first-in-human study of TRK-950 in patients with advanced solid tumors and is primarily designed to determine the dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of TRK-950 administered via intravenous (IV) infusion once weekly for 3 weeks every 28 days in Arm 1.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - TRK-950 | Experimental |
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| Arm 2 - TRK-950 | Experimental |
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| Arm 3 -TRK-950 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRK-950 | Biological | Intravenously over 60 minutes, on day 1, 8 and 15 of each cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | United States | ||
| HonorHealth Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37082579 | Derived | 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. |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| TRK-950 |
| Biological |
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 | Biological | Low dose: Intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle |
|
| 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 |
| Apparent volume of distribution(Vd) | through study completion, an average of 1 year |
| Tumor response rate | through study completion, an average of 1 year |
| Duration of response | through study completion, an average of 1 year |
| Time to progression | through study completion, an average of 1 year |
| Progression free survival | through study completion, an average of 1 year |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Centre Léon Bérard | Lyon | 69373 | France |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |