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Chemotherapy

Subcutaneous (SC) SEA-CD40 for Cancer

Phase 1

Waitlist Available

Research Sponsored by Seagen Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 6 years

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a new drug, SEA-CD40, when given alone or in combination with other drugs. The goal is to find the highest dose of SEA-CD40 that does not cause unacceptable side effects.

Eligible Conditions

Cancer
Pancreatic Adenocarcinoma
Non-Hodgkin's Lymphoma
Squamous Cell Neoplasms
Lymphoma
Head and Neck Neoplasms
Diffuse Large B-Cell Lymphoma
Squamous Cell Carcinoma
Non-Small Cell Lung Cancer
Hodgkin's Lymphoma
B-Cell Lymphoma
Follicular Lymphoma
Melanoma
Non-Small Cell Carcinoma
Squamous Cell Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events (Parts A-K)

Incidence of laboratory abnormalities (Parts A-K)

Objective response rate (ORR) per RECIST according to investigator assessment in the efficacy-evaluable population (Part L)

Secondary outcome measures

AUCinf (AUC from time 0 to infinity)

AUClast (AUC from time 0 to last quantifiable timepoint)

Apparent total clearance

+12 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: SC Monotherapy in Solid TumorsExperimental Treatment1 Intervention

SEA-CD40 administered SC

Group II: SC Monotherapy in LymphomasExperimental Treatment1 Intervention

SEA-CD40 administered SC

Group III: IV Monotherapy in Solid TumorsExperimental Treatment1 Intervention

SEA-CD40 administered IV

Group IV: IV Monotherapy in LymphomasExperimental Treatment1 Intervention

SEA-CD40 administered IV

Group V: Combination Therapy in Solid TumorsExperimental Treatment2 Interventions

SEA-CD40 (administered IV) + pembrolizumab

Group VI: Combination Therapy in Pancreatic CancerExperimental Treatment4 Interventions

SEA-CD40 (administered IV) + pembrolizumab + gemcitabine + nab-paclitaxel

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~2070

Nab-paclitaxel

2014

Completed Phase 3

~2030

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor

206 Previous Clinical Trials

68,998 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,884 Previous Clinical Trials

5,054,227 Total Patients Enrolled

Michael Schmitt, MD, PhDStudy DirectorSeagen Inc.

1 Previous Clinical Trials

16 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What conditions are most frequently treated with Subcutaneous (SC) SEA-CD40?

"Subcutaneous (SC) SEA-CD40 is a viable intervention for treating malignant neoplasms, unresectable melanoma, and microsatellite instability high."

Answered by AI

What is the sample size of this research initiative?

"At present, no additional enrolment is sought for this trial. The study was initially posted on February 28th 2015 and the most recent edit was registered on May 18th 2022. However, if you are seeking other trials there are 9440 studies actively recruiting participants with carcinoma, squamous cell as well as 1954 studies searching for patients to partake in a Subcutaneous (SC) SEA-CD40 clinical research program."

Answered by AI

What previous research exists regarding the administration of Subcutaneous (SC) SEA-CD40?

"The first clinical trials of subcutaneous SEA-CD40 were conducted in 1997 at City of Hope Comprehensive Cancer Center. Since then, 2073 studies have been completed and 1954 new ones are currently active; the bulk of which take place in Santa Monica, California."

Answered by AI

Has Subcutaneous (SC) SEA-CD40 been ratified by the FDA?

"As this is a Phase 1 trial, with only minimal evidence of efficacy and safety, the security rating for Subcutaneous SEA-CD40 was assessed as a score of 1."

Answered by AI

How widespread is this clinical trial's implementation?

"The Angeles Clinic and Research Institute, The in Santa Monica, California; Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute in Los Angeles, Nevada; and Comprehensive Cancer Centers of Nevada in Las Vegas Illinois are the primary sites for this trial. Additionally, there are 19 more locations taking part."

Answered by AI

Is recruitment currently ongoing for this trial?

"The clinicaltrials.gov website states that this medical research, which was initially published on February 28th 2015 and last revised on May 18th 2022, is now closed to new participants. Nonetheless, 11394 other studies are presently enrolling volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety Study of SEA-CD40 in Cancer Patients

2015. "Safety Study of SEA-CD40 in Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02376699.