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A Study on the Safety of GEN1044 (DuoBody®-CD3x5T4) in Patients With Malignant Solid Tumors

NCT04424641 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-07-25

Study results available
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Summary

The purpose of the trial is to evaluate the safety, determine the recommended Phase 2 dose (RP2D), and assess preliminary clinical activity of GEN1044 in patients with solid tumors.

Conditions

  • Locally Advanced or Metastatic Solid Tumor(s)
  • Prostate Cancer
  • Esophageal Cancer
  • Triple Negative Breast Cancer (TNBC)
  • Squamous Cell Carcinoma of Head and Neck (SCCHN)
  • Non-small Cell Lung Cancer (NSCLC)
  • Bladder Cancer
  • Uterine Cancer

Interventions

BIOLOGICAL

GEN1044 is an immunoglobulin G1 (IgG1) bispecific antibody targeting CD3 and 5T4.

GEN1044 will be administered intravenously in cycles of 21 days.

Sponsors & Collaborators

  • AbbVie

    collaborator INDUSTRY

  • Genmab

    lead INDUSTRY

Principal Investigators

  • Roberto Oliveri, MD · Genmab

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-15
Primary Completion
2021-10-29
Completion
2021-10-29
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • Israel
  • Spain

Study Locations

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Entities

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 NCT04424641 on ClinicalTrials.gov