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Monoclonal Antibodies

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

Phase 1 & 2
Waitlist Available
Research Sponsored by Genmab
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 day 1 through day 263 (predose on day 1 of cycles 1, 2, 3, 5, 7, and then on day 1 of every 4 cycles thereafter, end of treatment [eot], and 30 days after last study drug)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug called GEN1044 to see if it is safe and effective for patients with solid tumors. The study will determine the best dose to use and check if the drug can help manage or reduce the tumors.

Eligible Conditions
  • Lung Cancer
  • Prostate Cancer
  • Squamous Cell Carcinoma
  • Esophageal Cancer
  • Bladder Cancer
  • Cancer
  • Breast Cancer
  • Uterine Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 263 (predose on day 1 of cycles 1, 2, 3, 5, 7, and then on day 1 of every 4 cycles thereafter, end of treatment [eot], and 30 days after last study drug)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 263 (predose on day 1 of cycles 1, 2, 3, 5, 7, and then on day 1 of every 4 cycles thereafter, end of treatment [eot], and 30 days after last study drug) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Abnormal Laboratory Values
Number of Participants With Dose Limiting Toxicities (DLTs)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Secondary study objectives
Number of Participants With Antidrug Antibodies (ADAs) Positive to GEN1044
Number of Participants With Complete Response (CR) or Partial Response (PR)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: GEN1044Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

GenmabLead Sponsor
71 Previous Clinical Trials
14,873 Total Patients Enrolled
AbbVieIndustry Sponsor
1,035 Previous Clinical Trials
522,996 Total Patients Enrolled
Roberto Oliveri, MDStudy DirectorGenmab
~9 spots leftby Dec 2025
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