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This is a Phase 1, multi-center, open-label study of TRPH-222 monotherapy in subjects with relapsed and/or refractory B-cell NHL. The study will be conducted in two Stages: Dose-Escalation, Dose-Expansion.
In Dose Escalation, patients with DLBCL, FL (including transformed FL), MZL, and MCL were to be enrolled per dose cohort. In Dose Expansion, additional response-evaluable patients were to be enrolled in NHL subtype-specific cohorts including DLBCL and FL to confirm the RP2D identified in Escalation. Each stage consisted of screening, baseline, treatment, and follow-up periods. During the treatment period, patients were to be treated indefinitely in 21 day cycles. The EOT assessments were to occur 28 and 60 days after the last study treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Escalation | Experimental | Estimated to be <31 subjects across multiple centers |
|
| Expansion | Experimental | Estimated to be <121 subjects across multiple centers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRPH-222 | Drug | administered by IV, 21-day Cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) | To determine the MTD of TRPH-222 | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate incidence and severity of AEs, serious AEs, TRPH-222-related AEs, AEs leading to death or discontinuation from treatment | Safety | Up to 28 days after last dose of study drug |
| Tumor Activity |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Francisco J Hernandez- Ilizaliturri, MD | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson | Gilbert | Arizona | 85234 | United States | ||
| Roswell Park Comprehensive Cancer Center |
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Assess tumor response - ORR for each NHL subtype using Lugano criteria, PFS from first dose to disease progression, OS from first dose to death, DOR for each NHL subtype assessed by Lugano
| Up to 2 years |
| TRPH-222 Pharmacokinetics (PK) | Maximum concentration of TRPH-222 (Cmax), time to Cmax, Half-life (t 1/2), Exposure (area under the curve; AUC), Total body clearance (CL), Volume of distribution (Vd) | Each Cycle is 21 days. Days 1, 8, 15 of Cycle 1; Day 1 of Cycle 2 and Cycle 3; Day 1 of every third cycle thereafter; up to Day 28 after last dose of study drug; Day 60 after last dose of study drug |
| TRPH-222 anti-drug antibodies (ADA) | Assess the incidence of subjects who develop ADA to the ADC with TRPH-222 monotherapy | Prior to treatment, prior to C3D1 and every 3rd cycle thereafter, EOT60 |
| Buffalo |
| New York |
| 14263 |
| United States |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43219 | United States |
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Sarah Cannon Research Institute at Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D020522 | Lymphoma, Mantle-Cell |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| 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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