Description:
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.
Title
- Brief Title: Study of TRPH-222 in Patients With Relapsed and/or Refractory B-Cell Lymphoma
- Official Title: Phase 1, Multicenter, Open-Label Study of the Antibody-Drug Conjugate TRPH-222 in Subjects With Relapsed and/or Refractory B-Cell Lymphoma
Clinical Trial IDs
- ORG STUDY ID:
TRPH-222-100
- NCT ID:
NCT03682796
Conditions
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Non-Hodgkin
- Lymphoma, Mantle-Cell
- Lymphoma, Marginal Zone
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Follicular
Interventions
| Drug | Synonyms | Arms |
|---|
| TRPH-222 | | Escalation |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Escalation | Experimental | Estimated to be <31 subjects across multiple centers | |
| Expansion | Experimental | Estimated to be <121 subjects across multiple centers | |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years at the time of signing the informed consent
- Histologically confirmed (2016 WHO lymphoma classification) B-cell NHL that is DLBCL,
FL (including transformed FL), MZL, or MCL
- Relapsed and/or refractory NHL requiring systemic therapy and have failed, are
intolerant to, or are considered ineligible for standard of care anticancer treatments
that are known to be potentially curative. Subjects must not be current candidates for
HSCT. Participants who refuse standard treatments may also be considered provided that
documentation is provided that the subject has been made aware of all therapeutic
options
- Eastern Cooperative Oncology Group (ECOG) status 0-2
Exclusion Criteria
- Presence of a leukemic phase of the lymphoma
- "Double hit" or "triple hit" germinal center B cell lymphoma
- Previous solid organ allograft (except for corneal transplant)
- Peripheral neuropathy > NCI-CTCAE Grade 1
- Significant organ dysfunction that would preclude study participation
- Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias
- Any other serious active disease or co-morbid medical condition, according to the
Investigator's decision or Medical Monitor, that will substantially increase the risk
associated with the subject's participation in the study
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Maximum Tolerated Dose (MTD) |
| Time Frame: | 21 days |
| Safety Issue: | |
| Description: | To determine the MTD of TRPH-222 |
Secondary Outcome Measures
| Measure: | Evaluate incidence and severity of AEs, serious AEs, TRPH-222-related AEs, AEs leading to death or discontinuation from treatment |
| Time Frame: | Up to 28 days after last dose of study drug |
| Safety Issue: | |
| Description: | Safety |
| Measure: | Tumor Activity |
| Time Frame: | Up to 2 years |
| Safety Issue: | |
| Description: | 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 |
| Measure: | TRPH-222 Pharmacokinetics (PK) |
| Time Frame: | 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 |
| Safety Issue: | |
| Description: | Maximum concentration of TRPH-222 (Cmax) |
| Measure: | TRPH-222 Pharmacokinetics (PK) |
| Time Frame: | 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 |
| Safety Issue: | |
| Description: | Time to Cmax |
| Measure: | TRPH-222 Pharmacokinetics (PK) |
| Time Frame: | 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 |
| Safety Issue: | |
| Description: | Half-life (t 1/2) |
| Measure: | TRPH-222 Pharmacokinetics (PK) |
| Time Frame: | 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 |
| Safety Issue: | |
| Description: | Exposure (area under the curve; AUC) |
| Measure: | TRPH-222 Pharmacokinetics (PK) |
| Time Frame: | 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 |
| Safety Issue: | |
| Description: | Total body clearance (CL) |
| Measure: | TRPH-222 Pharmacokinetics (PK) |
| Time Frame: | 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 |
| Safety Issue: | |
| Description: | Volume of distribution (Vd) |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Triphase Research and Development III Corp. |
Trial Keywords
- Antibody-Drug Conjugate
- ADC
- CD22
- SMARTag™ technology
- TRPH-222
Last Updated
April 1, 2021
