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SGN-40

Phase 2

Lymphoma, Large B-Cell, Diffuse | Small molecule | Oncology |Pfizer, Inc.|Trials Updated: Jan 7, 2015

SGN-40 development status

Highest phase Phase 2
Registered trials 6 across 2 sponsors since Feb 2007

SGN-40 target and mechanism

ModalitySmall molecule

Also known as SGN-40 (anti-huCD40 mAb), dacetuzumab

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials6
Total Enrollment221

FDA Designations

No designations recorded

SGN-40 clinical trials

SGN-40 · 6 trials · 5 indications

Phase 2 1Phase 1 5
NCT00435916Study of SGN-40 in Patients With Relapsed Diffuse Large B-Cell LymphomaLymphoma, Large B-Cell, Diffuse
COMPLETED46 Analytics
PHASE2COMPLETED
Study of SGN-40 in Patients With Relapsed Diffuse Large B-Cell Lymphoma
Lymphoma, Large B-Cell, DiffuseUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective response as assessed by CT and PET scans and revised response criteria for malignant lymphoma.
Every 1 or 2 months
Determine the safety and adverse-event profile for combination therapy of SGN-40 with gemcitabine and rituximab.
10 months from registration of last patient
Adverse events and lab abnormalities.
Within 3 weeks of final infusion of SGN-40
To determine the maximum tolerated dose (MTD) of multiple doses of SGN-40
To evaluate the safety profile, immunogenicity, and pharmacokinetics of SGN-40
To test the antitumor activity of SGN-40 in patients with CLL who have demonstrated recurrence or progression after at least one systemic therapy

Secondary Endpoints

Progression-free survival, disease-free survival, and overall survival.
Study duration
Adverse events, laboratory values, and anti-drug antibody immune responses.
Within 3 weeks of final infusion
PK profile.
Within 3 weeks of final infusion
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -

Interventions

NameTypeDescription
SGN-40DRUG1-8 mg/kg IV (in the vein) on Days 1, 4, 8, 15, 22 and 29 of Cycle 1; 8 mg/kg IV (in the vein) on Days 1, 8, 15, and 22 for Cycles 2-12.
rituximabDRUG375 mg/m2 IV injection; Days -2, 8, 15 and 22 of Cycle 1 and Day 1 of Cycles 2-8.
gemcitabineDRUG1000 mg/m2 IV Injection; Days 1 and 15 of all Cycles.
lenalidomideDRUGUp to 25 mg daily of a 21-day cycle.
dexamethasoneDRUG40 mg administered weekly.
SGN-40 (anti-huCD40 mAb)DRUG1-8 mg/kg IV; Days 1, 4, 8, 15, 22, 29 of Cycle 1 and Days 1, 15, 29 and 43 of Cycles 2-6.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Diagnosis of DLBCL. * Received at least one combination chemotherapy regimen with rituximab, such as R-CHOP, R-ESHAP or equivalent. * Progression or relapse since most recent therapy. * At least one measurable lesion that is both greater than or equal to 2 cm by conventional C...

Countries:United States
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Frequently asked questions about SGN-40

What is SGN-40?

SGN-40 is an investigational monoclonal antibody developed by Pfizer, Inc. (ticker: PFE) for oncology indications. It has been studied in chronic lymphocytic leukemia, diffuse large B-cell lymphoma, multiple myeloma, and non-Hodgkin lymphoma. It is not approved and remains in clinical development.

What is SGN-40 used for in leukemia and lymphoma?

SGN-40 has been studied in chronic lymphocytic leukemia, diffuse large B-cell lymphoma, multiple myeloma, and non-Hodgkin lymphoma. It is an investigational agent and is not approved for any indication. All clinical trials of SGN-40 have been completed.

Who makes SGN-40?

SGN-40 is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the sponsor of the clinical trials evaluating SGN-40 in hematologic malignancies.

What phase is SGN-40 in?

SGN-40 is in Phase 1 development. It is investigational and has not been approved by the FDA. Two Phase 1 trials and one Phase 2 trial have been completed, with no active trials ongoing.

What clinical trials is SGN-40 in?

SGN-40 has been evaluated in completed trials including NCT00655837 in diffuse large B-cell lymphoma, NCT00525447 in multiple myeloma, NCT00435916 in relapsed diffuse large B-cell lymphoma, and NCT00283101 in chronic lymphocytic leukemia. All trials are completed and no active trials are ongoing.

Is SGN-40 the same as SGN-40 (anti-huCD40 mAb)?

Yes, SGN-40 is also known as SGN-40 (anti-huCD40 mAb). Both names refer to the same investigational monoclonal antibody developed by Pfizer, Inc. for hematologic malignancies.