LymphomaPhase 1NCT03682796
Study of TRPH-222 in Patients With Relapsed and/or Refractory B-Cell Lymphoma
A Phase 1 study testing TRPH-222 in people with Lymphoma and Lymphoma, B-Cell, run by Triphase Research and Development III Corp. at 7 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Lymphoma, B-Cell, Lymphoma, Non-Hodgkin
- What is being tested?
- TRPH-222
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 15 Oct 2018to 17 Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43219
Banner MD Anderson
Gilbert, Arizona, 85234
Sarah Cannon Research Institute at Tennessee Oncology
Nashville, Tennessee, 37203
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Canada2 sites
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
About this study
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
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.
Read the detailed description
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.
- Conditions
- Lymphoma, Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Lymphoma, Mantle-Cell, Lymphoma, Marginal Zone, Lymphoma, Large B-Cell, Diffuse
- Being tested
- TRPH-222
- Keywords
- Antibody-Drug Conjugate, ADC, CD22, SMARTag™ technology, TRPH-222
- Medical subject headings
- Lymphoma, Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRPH-222Drug
administered by IV, 21-day Cycle
| Study group | Role | What they receive |
|---|---|---|
| Escalation | Experimental | Estimated to be <31 subjects across multiple centers Receives: Drug: TRPH-222 |
| Expansion | Experimental | Estimated to be <121 subjects across multiple centers Receives: Drug: TRPH-222 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
To determine the MTD of TRPH-222
Measured: 21 days
Secondary outcomes (4)
Evaluate incidence and severity of AEs, serious AEs, TRPH-222-related AEs, AEs leading to death or discontinuation from treatment
Safety
Measured: Up to 28 days after last dose of study drug
Tumor Activity
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
Measured: 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)
Measured: 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
Measured: Prior to treatment, prior to C3D1 and every 3rd cycle thereafter, EOT60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start15 Oct 2018
- Primary completion17 Nov 2021
- Study completion17 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Triphase Research and Development III Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francisco J Hernandez- Ilizaliturri, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682796
- Sponsor's protocol ID
- TRPH-222-100
- Status last verified
- May 2022
- First submitted
- 20 Sep 2018
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03682796
- Acronym / sponsor ID
- TRPH-222-100
- Conditions
- Lymphoma, Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Lymphoma, Mantle-Cell, Lymphoma, Marginal Zone, Lymphoma, Large B-Cell, Diffuse
- Keywords
- Antibody-Drug Conjugate, ADC, CD22, SMARTag™ technology, TRPH-222
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Triphase Research and Development III Corp.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 17 Nov 2021 (actual)
- Study completion
- 17 Nov 2021 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Escalation | Experimental | Drug: TRPH-222Estimated to be <31 subjects across multiple centers |
| Expansion | Experimental | Drug: TRPH-222Estimated to be <121 subjects across multiple centers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRPH-222administered by IV, 21-day Cycle | Drug | Escalation, Expansion |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 21 days
To determine the MTD of TRPH-222
4 secondary outcomes
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
Tumor Activity
Time frame: Up to 2 years
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
TRPH-222 anti-drug antibodies (ADA)
Time frame: Prior to treatment, prior to C3D1 and every 3rd cycle thereafter, EOT60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco J Hernandez- Ilizaliturri, MD principal investigator
Roswell Park Cancer Institute
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TRPH-222 in people with Lymphoma and Lymphoma, B-Cell, run by Triphase Research and Development III Corp. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.