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GEN1042 Safety Trial in Subjects With Malignant Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04083599
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : May 5, 2020
BioNTech SE
Information provided by (Responsible Party):

Brief Summary:
To evaluate the safety of GEN1042 in patients with malignant solid tumors

Condition or disease Intervention/treatment Phase
Malignant Solid Tumor Non Small Cell Lung Cancer Colorectal Cancer Melanoma Biological: GEN1042 Phase 1 Phase 2

Detailed Description:
The trial is an open-label, multi-center, safety trial of GEN1042. The trial consists of two parts, a dose escalation (phase 1, first-in-human (FIH) and an expansion part (Phase 2a). The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) has been determined.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A First-in-Human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1042 in Subjects With Malignant Solid Tumors
Actual Study Start Date : September 17, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment Administered
GEN1042 will be administered every 21 days
Biological: GEN1042
GEN1042 will be administered intravenously every 21 days. The dose level will be determined by the starting dose and escalation steps in the trial.

Primary Outcome Measures :
  1. Dose Limiting Toxicity (DLT) [ Time Frame: First Cycle (21 days) ]
    Determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D)

  2. Adverse Events (AEs) [ Time Frame: Throughout study until the end of the safety follow-up period (2 months after last dose)] ]
    Incidence of adverse events as assessed by CTCAE v5.0

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Dose Escalation:

• Histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is no available standard therapy.


• Histologically or cytologically confirmed diagnosis of relapsed or refractory, advanced and/or metastatic melanoma, NSCLC, or CRC who are not anymore candidates for standard therapy

Dose Escalation and Expansion:

  • Measurable disease according to RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) 0-1
  • Acceptable bone marrow and hematological, liver and renal functions
  • Acceptable coagulation status

Exclusion Criteria:

Uncontrolled intercurrent illness, including but not limited to:

  • Ongoing or active infection treated with intravenous anti-infective therapy less than 2 weeks prior to first dose
  • Symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
  • Uncontrolled hypertension despite optimal medical management.
  • Evidence of significant autoimmune disease suggesting risk for immune-related adverse events (irAEs).
  • History of irAEs that led to treatment discontinuation of prior ICP inhibitor
  • • History of chronic liver disease or evidence of hepatic cirrhosis.
  • History of non-infectious pneumonitis that required steroids or currently has pneumonitis.
  • History of organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of GEN1042.
  • Serious, non-healing wound, skin ulcer (of any grade), or bone fracture.
  • Any history of intracerebral arteriovenous malformation, cerebral aneurysm, or progressive brain metastases or stroke.

Prior therapy:

  • Radiotherapy within 14 days prior to first GEN1042 administration
  • Treatment with an anti-cancer agent (within 21 days or after at least 5 half-lives of the drug, whichever is shorter), prior to GEN1042 administration.
  • History of ≥ grade 3 allergic reactions to monoclonal antibody (mAb) therapy
  • Toxicities from previous anti-cancer therapies that have not resolved

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04083599

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Contact: Genmab A/S Trial Information +4570202728 ext +4570202728

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United States, Indiana
Sarah Cannon Research Institute Recruiting
Indianapolis, Indiana, United States, 37203
Principal Investigator: Melissa Johnson         
Rigshospitalet (Copenhagen University Hospital) Recruiting
Copenhagen, Denmark
Principal Investigator: Kristoffer Rohrberg         
United Kingdom
Royal Marsden NHS Foundation Trust Recruiting
Sutton, United Kingdom
Principal Investigator: Dr. Juanita Lopez         
Sponsors and Collaborators
BioNTech SE
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Responsible Party: Genmab Identifier: NCT04083599    
Other Study ID Numbers: GCT1042-01
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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