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| Name | Class |
|---|---|
| Translational Research in Oncology | OTHER |
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This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-4-500 in patients with advanced cancer.
For Part 1, any advanced or metastatic solid tumor malignancy will be evaluated including, for example, adrenocortical carcinoma (ACC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy Dose Dose Finding - Part 1 | Experimental | TORL-4-500 iv once every 3 weeks |
|
| Expansion as Monotherapy - Part 2 | Experimental | TORL-4-500 iv once every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TORL-4-500 | Drug | antibody drug conjugate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events and serious adverse events | Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0 | up to 2 years |
| Maximum Tolerated Dose (MTD) | Highest administered dose with < 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants | 28 Days |
| Recommended Phase 2 Dose (RP2D) | Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1 | up to 2 years |
| Duration of Response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Labib, PharmD | Contact | 310-348-9636 | caroline.labib@torlbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Caroline Labib, PharmD | TORL Biotherapeutics, LLC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Phoenix | Recruiting | Phoenix | Arizona | 85054 | United States |
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Time from CR or PR to objective disease progression or death to any cause
| up to 2 years |
| Progression Free Survival (PFS) | PFS is defined as the time from the start of the treatment until objective disease progression or death from any cause | up to 2 years |
| Time to Response (TTR) | Time from start of treatment to complete response or partial response | up to 2 years |
| 1 Year Overall Survival (1YOS) | Proportion of participants alive at 1 year from the start of treatment to death from any cause | 1 year |
| 2 Year Overall Survival (2YOS) | Proportion of participants alive at 2 years from the start of treatment to death from any cause | 2 years |
| Number of anti-drug antibody (ADA) Positive Participants | Immunogenicity will be measured by the number of participants that are ADA positive. | up to 2 years |
| Maximum Serum Concentration of TORL-4-500 (Cmax) | PK assessment | 21 days |
| Minimum Serum Concentration of TORL-4-500 (Cmin) | PK assessment | 21 days |
| Maximum Serum Concentration of TORL-4-500 at Steady State (Cmax,ss) | PK assessment | 63 days |
| Minimum Serum Concentration of TORL-4-500 at Steady State (Cmin,ss) | PK assessment | 63 days |
| Time of Maximum Serum Concentration of TORL-4-500 (Tmax) | PK assessment | 21 days |
| Time of Minimum Serum Concentration of TORL-4-500 (Tmin) | PK Assessment | 21 days |
| Time of Minimum Serum Concentration of TORL-4-500 at Steady State (Tmin,ss) | PK Assessment | 63 days |
| Terminal Half-life (t1/2) of Serum TORL-4-500-ADC | PK Assessment | 63 days |
| Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-4-500 | PK Assessment | 21 days |
| Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-4-500 | PK Assessment | 63 days |
| Apparent volume of distribution during the terminal phase (Vz) of TORL-4-500 | PK Assessment | 63 days |
| Clearance (CL) of TORL-4-500 | PK Assessment | 63 days |
| Accumulation ratio (Rac) of TORL-4-500 | PK Assessment | 63 days |
| Providence Medical Foundation | Recruiting | Fullerton | California | 92835 | United States |
|
| UCLA - JCCC Clinical Research Unit | Recruiting | Los Angeles | California | 90095 | United States |
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| Torrance Memorial Physician Network | Recruiting | Torrance | California | 90505 | United States |
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| Mayo Clinic Jacksonville | Recruiting | Jacksonville | Florida | 32224 | United States |
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| Florida Cancer Specialists Lake Nona Drug Development Unit | Recruiting | Orlando | Florida | 32827 | United States |
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| Mayo Clinic Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Virginia Cancer Specialists | Recruiting | Lexington | Virginia | 22031 | United States |
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| University Health Network, Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
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| McGill University Health Centre | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
|
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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