Trials / Terminated
TerminatedNCT04424641
A Study on the Safety of GEN1044 (DuoBody®-CD3x5T4) in Patients With Malignant Solid Tumors
First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1044 in Subjects With Malignant Solid Tumors
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Genmab · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The trial is an open-label, multi-center safety trial of GEN1044. The trial consists of two parts: a dose-escalation part (Phase 1) and an expansion part (Phase 2a). The expansion part of the trial will be initiated once the RP2D has been determined from Phase 1.
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
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GEN1044 is an immunoglobulin G1 (IgG1) bispecific antibody targeting CD3 and 5T4. | GEN1044 will be administered intravenously in cycles of 21 days. |
Timeline
- Start date
- 2020-07-15
- Primary completion
- 2021-10-29
- Completion
- 2021-10-29
- First posted
- 2020-06-11
- Last updated
- 2023-07-25
- Results posted
- 2023-02-01
Locations
6 sites across 4 countries: United States, Denmark, Israel, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04424641. Inclusion in this directory is not an endorsement.