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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-2-307-ADC in patients with advanced cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy Dose Dose Finding - Part 1 | Experimental | TORL-2-307-ADC |
|
| Expansion as Monotherapy - Part 2 | Experimental | TORL-2-307-ADC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TORL-2-307-ADC | 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 | Affiliation | Role |
|---|---|---|
| Ibrahim Qazi, PharmD | TORL Biotherapeutics, LLC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence St. Jude Medical Center | Fullerton | California | 92835 | United States | ||
| UCLA - JCCC Clinical Research Unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37788341 | Derived | O'Brien NA, McDermott MSJ, Zhang J, Gong KW, Lu M, Hoffstrom B, Luo T, Ayala R, Chau K, Liang M, Madrid AM, Donahue TR, Glaspy JA, Presta L, Slamon DJ. Development of a Novel CLDN18.2-directed Monoclonal Antibody and Antibody-Drug Conjugate for Treatment of CLDN18.2-Positive Cancers. Mol Cancer Ther. 2023 Dec 1;22(12):1365-1375. doi: 10.1158/1535-7163.MCT-23-0353. |
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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-2-307-ADC (Cmax) | PK assessment | 21 days |
| Minimum Serum Concentration of TORL-2-307-ADC (Cmin) | PK assessment | 21 days |
| Maximum Serum Concentration of TORL-2-307-ADC at Steady State (Cmax,ss) | PK assessment | 63 days |
| Minimum Serum Concentration of TORL-2-307-ADC at Steady State (Cmin,ss) | PK assessment | 63 days |
| Time of Maximum Serum Concentration of TORL-2-307-ADC (Tmax) | PK assessment | 21 days |
| Time of Minimum Serum Concentration of TORL-2-307-ADC (Tmin) | PK Assessment | 21 days |
| Time of Minimum Serum Concentration of TORL-2-307-ADC at Steady State (Tmin,ss) | PK Assessment | 63 days |
| Terminal Half-life (t1/2) of Serum TORL-2-307-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-2-307-ADC | PK Assessment | 21 days |
| Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-2-307-ADC | PK Assessment | 63 days |
| Apparent volume of distribution during the terminal phase (Vz) of TORL-2-307-ADC | PK Assessment | 63 days |
| Clearance (CL) of TORL-2-307-ADC | PK Assessment | 63 days |
| Accumulation ratio (Rac) of TORL-2-307-ADC | PK Assessment | 63 days |
| Los Angeles |
| California |
| 90095 |
| United States |
| Torrance Memorial Medical | Torrance | California | 90505 | United States |
| Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | 46804 | United States |
| Washington University School of Medicine-Siteman Cancer Center | St Louis | Missouri | 63310 | United States |
| Texas Oncology-Austin | Austin | Texas | 78705 | United States |
| Texas Oncology-Dallas | Dallas | Texas | 75246 | United States |
| START San Antonio | San Antonio | Texas | 78229 | United States |
| Texas Oncology-Tyler | Tyler | Texas | 75702 | United States |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Seoul National University Bundang Hospital | Seoul | 13620 | South Korea |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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