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A Phase 1/2 study to evaluate safety, tolerability, and anticancer activity of TORL-5-700 as a monotherapy and in combination in R/R NHL
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Monotherapy Dose Escalation | Experimental | TORL-5-700 Administered once every three weeks |
|
| Part 2: Monotherapy Expansion | Experimental | TORL-5-700 at MTD/RP2D Administered once every three weeks |
|
| Part 3: Combination Evaluation | Experimental | TORL-5-700 at MTD/RP2D Administered once every three weeks in combination with another agent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TORL-5-700 | Drug | Part 1: Monotherapy Dose Escalation - TORL-5-700 Administered once every three weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety of TORL-5-700 as a monotherapy | Assessment of adverse events according to NCI-CTCAE Version 5.0 | though study completion, an average of 2.5 years |
| Assess the antitumor activity of TORL-5-700 as monotherapy | Assess the antitumor activity of TORL-5-700 using Cheson (2014) disease grading criteria | though study completion, an average of 2.5 years |
| Evaluate the safety of TORL-5-700 in combination with other agents | Assessment of adverse events according to NCI-CTCAE Version 5.0 | though study completion, an average of 2.5 years |
| Determine the Maximum Tolerated Dose (MTD) | Determine the MTD by assessing Protocol defined Dose Limiting Toxicities (DLT) | 21 days from the start of treatment |
| Determine the Recommended Phase 2 Dose (RP2D) | Determine the RP2D by assessing Protocol defined Dose Limiting Toxicities | 21 days from the start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Serum Concentration of TORL-5-700 (Cmax) | Pk assessment | though end of study treatment, an average of 5 months |
| Maximum Serum Concentration of TORL-5-700 (Cmax) in combination with other agents |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Timothy Welliver, M.D. | Contact | (310) 598-5969 | timothy.welliver@torlbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Recruiting | Santa Monica | California | 90404 | United States | |
| Stanford University |
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| TORL-5-700 at MTD/RP2D | Drug | Part 2: Monotherapy Expansion - TORL-5-700 at Maximum tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) Administered once every three weeks |
|
| TORL-5-700 at MTD/RP2D in combination with another agent | Drug | Part 3: Combination Evaluation - TORL-5-700 at MTD/RP2D administered every three weeks in combination with another agent |
|
Pk assessment
| though end of study treatment, an average of 5 months |
| Terminal Half-life (t1/2) of Serum TORL-5-700 | Pk assessment | though end of study treatment, an average of 5 months |
| Terminal Half-life (t1/2) of Serum TORL-5-700 in combination with other agents | Pk assessment | though end of study treatment, an average of 5 months |
| Area under the Serum Concentration -Time curve for TORL-5-700 from the time of dosing to the last measurable concentration | Pk assessment | though end of study treatment, an average of 5 months |
| Area under the Serum Concentration -Time curve for TORL-5-700 from the time of dosing to the last measurable concentration in combination with other agents | Pk assessment | though end of study treatment, an average of 5 months |
| Clearance (CL) of TORL-5-700 | Pk assessment | though end of study treatment, an average of 5 months |
| Clearance (CL) of TORL-5-700 in combination with other agents | Pk assessment | though end of study treatment, an average of 5 months |
| Volume of distribution of TORL-5-700 | PK assessment | though end of study treatment, an average of 5 months |
| Volume of distribution of TORL-5-700 in combination with other agents | PK assessment | though end of study treatment, an average of 5 months |
| Immunogenicity of TORL-5-700 | Immunogenicity will be measured by incidence of treatment emergent ADAs | though end of study treatment, an average of 5 months |
| Immunogenicity of TORL-5-700 in combination with other agents | Immunogenicity will be measured by incidence of treatment emergent ADAs | though end of study treatment, an average of 5 months |
| Assess the preliminary antitumor activity of TORL-5-700 in combination with other agents | Assess the antitumor activity of TORL-5-700 in combination with other agents using Cheson (2014) disease grading criteria | though study completion, an average of 2.5 years |
| Recruiting |
| Stanford |
| California |
| 94305 |
| United States |
| Sarah Cannon Research Institute | Recruiting | Nashville | Tennessee | 37203 | United States |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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