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Safety Study of SEA-CD40 in Cancer Patients

NCT02376699 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2023-05-01

No results posted yet for this study

Summary

This study is being done to find out if SEA-CD40 is safe and effective when given alone, in combination with pembrolizumab, and in combination with pembrolizumab, gemcitabine, and nab-paclitaxel. The study will test increasing doses of SEA-CD40 given at least every 3 weeks to small groups of patients. The goal is to find the highest dose of SEA-CD40 that can be given to patients that does not cause unacceptable side effects. Different dose regimens will be evaluated. Different methods of administration may be evaluated. The pharmacokinetics, pharmacodynamic effects, biomarkers of response, and antitumor activity of SEA-CD40 will also be evaluated.

Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Melanoma
  • Neoplasm Metastasis
  • Neoplasms, Head and Neck
  • Neoplasms, Squamous Cell
  • Non-Small Cell Lung Cancer
  • Non-Small Cell Lung Cancer Metastatic
  • Non-small Cell Carcinoma
  • Squamous Cell Cancer
  • Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of the Head and Neck
  • Squamous Cell Neoplasm
  • Lymphoma, Non-Hodgkin
  • Pancreatic Adenocarcinoma

Interventions

DRUG

Intravenous (IV) SEA-CD40

Given intravenously; schedule is cohort-specific.

DRUG

Pembrolizumab

Given intravenously; schedule is cohort-specific.

DRUG

Subcutaneous (SC) SEA-CD40

Given subcutaneously on Day 1 every 3 weeks

DRUG

Gemcitabine

1000 mg/m\^2 given intravenously on Day 1, 8, and 15 of each 28-day cycle

DRUG

Nab-paclitaxel

125 mg/m\^2 given intravenously on Day 1, 8, and 15 of each 28-day cycle

Sponsors & Collaborators

Principal Investigators

  • Michael Schmitt, MD, PhD · Seagen Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2023-03-06
Completion
2023-04-14

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02376699 on ClinicalTrials.gov