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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

GEN1042 Safety Trial in Subjects With Malignant Solid Tumors

Clinicaltrials.gov identifier NCT03937024

Recruitment Status Not yet recruiting

First Posted May 3, 2019

Last update posted May 3, 2019

Study Description

Brief summary:

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

  • Condition or Disease:Malignant Solid Tumor
    Non Small Cell Lung Cancer
    Colorectal Cancer
    Melanoma
  • Intervention/Treatment: Biological: GEN1042
  • Phase: 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.

Study Design
  • Study Type: Interventional
  • 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
  • Estimated Study Start Date: July 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: July 2022
Arms and interventions
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
Outcome Measures
  • 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
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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.

Expansion:

• 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 myositis, Guillain-Barré syndrome, or myasthenia gravis (any grade)

- 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, new (< 6 months) or progressive brain metastases or stroke. Prior therapy: - Radiotherapy within 14 days prior to first GEN1042 administration - Treatment with an anti-cancer agent (within 28 days or after at least 4 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

Contacts and Locations
Contacts

Contact: Genmab A/S Trial Information +4570202728 clinicaltrials@genmab.com

Locations
Sponsors and Collaborators

Genmab

Biontech AG

More Information
  • Responsible Party: Genmab
  • ClinicalTrials.gov Identifier: NCT03937024 History of Changes
  • Other Study ID Numbers: GCT1042-01
  • First Posted: May 3, 2019 Key Record Dates
  • Last Update Posted: May 3, 2019
  • Last Verified: May 2019
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Carcinoma, Non-Small-Cell Lung
    Colorectal Neoplasms
    Neoplasms