Secura Bio® | Clinical Development

ongoing clinical trials

The information presented below does not make any claims with regard to safety or efficacy. There are no guarantees that the outcomes of these studies will result in regulatory approval(s).

DUVELISIB

Study

Therapeutic Area

Status

Phase 1 2 3 4

Study

PRIMO Single-agent
NCT03372057

Therapeutic Area

Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL)

Status

Fully Enrolled

Phase 1 2 3 4

Title

A Study of Duvelisib in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL)

Study Description

This multicenter, phase 2, open-label, parallel-cohort efficacy and safety study contains 2 phases: a dose optimization phase and an expansion phase:

Outcome Measures

Primary

Objective response rate (ORR [CR + PR])

Select Secondary^†

Duration of response
Disease control rate
Progression-free survival
Overall survival
Safety

Eligibility Criteria

Select Inclusion Criteria^†

Diagnosis of one of the following PTCL histologic subtypes: PTCL-NOS, AITL, ALCL, or NKTL
Patients with CD30+ ALCL who have failed to respond to or are ineligible for brentuximab vedotin
Measurable disease as defined by IWG for PTCL
At least 1 prior treatment regimen
≥18 years of age, ECOG performance status ≤2

Select Exclusion Criteria^†

Clinical evidence of transformation to a more aggressive subtype of lymphoma or mycosis fungoides
Received prior treatment with a phosphoinositide-3-kinase inhibitor
Known central nervous system PTCL involvement
Prior HSCT
Certain viral infections or a history of tuberculosis
Chronic immunosuppression
Ongoing treatment for systemic bacterial, viral, or fungal infections

*Estimated enrollment.

^†Additional measures/criteria apply.

AITL, angioimmunoblastic T-cell lymphoma; ALCL, anaplastic large cell lymphoma; BID, twice daily; CD30+, cluster of differentiation 30 positive; CR, complete response; ECOG, Eastern Cooperative Oncology Group; HSCT, hematopoietic stem cell transplant; IWG, International Working Group; NKTL, natural-killer/T-cell lymphoma; PO, orally; PR, partial response; PTCL-NOS, peripheral T-cell lymphoma-not otherwise specified.

For complete trial information, visit https://ClinicalTrials.gov/ct2/show/NCT03372057.

See

Study

Therapeutic Area

Status

Phase 1 2 3 4

Study

TEMPO Intermittent dosing
NCT04038359

Therapeutic Area

Indolent Non-Hodgkin Lymphoma (iNHL)

Status

Fully Enrolled*

Phase 1 2 3 4

Title

A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects With Indolent Non-Hodgkin Lymphoma (iNHL) (TEMPO)

Study Description

This phase 2, randomized, open-label, 2-arm study is designed to evaluate the efficacy and safety of prescribed drug holidays of duvelisib treatment in subjects with relapsed or refractory (R/R) iNHL who have received at least 1 prior systemic therapy. Patient arms are based on 2 different dosing schedules:

Outcome Measures

Primary

Overall response rate

Select Secondary^†

Overall response rate at 6, 12, 18, and 24 months
Progression-free survival
Time to treatment failure
Duration of response
Overall survival
Lymph node response rate
Time to first response
Safety

Eligibility Criteria

Select Inclusion Criteria^†

Histologically confirmed diagnosis of iNHL or SLL
Must have received 1 prior systemic regimen for iNHL
≥18 years of age, ECOG performance status ≤2

Select Exclusion Criteria^†

Anticancer treatment, major surgery, or use of any investigational drug within 28 days before the start of study intervention
Clinical or histologic evidence of transformation to a more aggressive subtype of lymphoma or grade 3b FL or Richters' transformation or CLL
Prior allogeneic HSCT
Treatment with a PI3K inhibitor
History of drug-induced colitis or pneumonitis
TB treatment ≤2 years prior to randomization
Ongoing treatment with chronic immunosuppressants or systemic steroids or treatment for systemic bacterial, fungal, or viral infection

*Recruitment status is complete according to ClinicalTrials.gov; however, awaiting clinical study report.

^†Additional measures/criteria apply.

BID, twice daily; CLL, chronic lymphocytic leukemia; ECOG, Eastern Cooperative Oncology Group; FL, follicular lymphoma; HSCT, hematopoietic stem cell transplant; PI3K, phosphoinositide-3-kinase; SLL, small lymphocytic lymphoma; TB, tuberculosis.

For complete trial information, visit https://Clinica1Trials.qov/ct2/show/NCT04038359.

See

INVESTIGATOR SPONSORED STUDIES

If you're interested in submitting a proposal for an investigator sponsored study, you can contact us at iss@securabio.com.

AREAS OF RESEARCH INTEREST WITH DUVELISIB

Areas of interest to the clinical development program include:

CLL/SLL
iNHL
T-cell lymphoma
Select solid tumors
Real-world data
Health economics and outcomes research
Novel dosing and dosing schedules

Also being considered for hematologic malignancies and solid tumors are combination regimens with:

CAR T-cell therapies
Bispecific antibodies
Immunotherapies
BTK and BCL2 inhibitors
Other therapies with novel mechanisms of action

CONTINUING MEDICAL EDUCATION (CME) GRANTS

If you're interested in submitting a request for a CME grant, you can contact us at grants@securabio.com.

BCL2, B-cell lymphoma 2; BTK, Bruton tyrosine kinase; CAR T, chimeric antigen receptor T cell; CLL/SLL, chronic lymphocytic leukemia/small lymphocytic lymphoma; iNHL, indolent non-Hodgkin lymphoma.

CLINICAL DEVELOPMENT

ongoing clinical trials

DUVELISIB

Title

Study Description

Primary

Select Secondary†

Select Inclusion Criteria†

Select Exclusion Criteria†

Title

Study Description

Primary

Select Secondary†

Select Inclusion Criteria†

Select Exclusion Criteria†

INVESTIGATOR SPONSORED STUDIES

AREAS OF RESEARCH INTEREST WITH DUVELISIB

CONTINUING MEDICAL EDUCATION (CME) GRANTS

Select Secondary^†

Select Inclusion Criteria^†

Select Exclusion Criteria^†

Select Secondary^†

Select Inclusion Criteria^†

Select Exclusion Criteria^†