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SGN-40

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment79

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

SGN-40 is an investigational oncology drug being studied for multiple myeloma, chronic lymphocytic leukemia, diffuse large B-cell lymphoma, and non-Hodgkin lymphoma. It is a small molecule developed by Pfizer, Inc. (NYSE: PFE). SGN-40 is not FDA approved and remains in clinical development.

Who makes SGN-40?

SGN-40 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is an investigational small molecule in the oncology therapeutic area, studied for blood cancers including multiple myeloma and lymphoma.

What phase is SGN-40 in?

SGN-40 is in Phase 1 clinical development. It has completed two Phase 1 trials and one Phase 2 trial, but no trials are currently active. The drug is investigational and has not received FDA approval.

What clinical trials is SGN-40 in?

SGN-40 has completed four clinical trials, including NCT00079716 in refractory or recurrent multiple myeloma, NCT00435916 in relapsed diffuse large B-cell lymphoma, NCT00525447 combining SGN-40 with lenalidomide and dexamethasone in multiple myeloma, and NCT00655837 combining SGN-40 with rituximab and gemcitabine in DLBCL.

Is SGN-40 the same as any other drug?

SGN-40 is the primary name for this investigational drug. No alternative names have been reported for this asset. It is a small molecule being studied for multiple myeloma and various lymphomas, developed by Pfizer, Inc.