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GEN1046 Safety Trial in Patients With Malignant Solid Tumors

Trial Status: Active

The purpose of the trial is to evaluate the safety of GEN1046 in patients with malignant solid tumors

Inclusion Criteria

  • Inclusion Criteria: For Dose Escalation: • Have a histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is no available standard therapy For Expansion: • Have histologically or cytological confirmed diagnosis of relapsed or refractory, advanced and/or metastatic NSCLC, EC, UC, TNBC, SCCHN, or cervical cancer who are not anymore candidates for standard therapy For Both Dose Escalation and Expansion - Have measurable disease according to RECIST 1.1 - Have Eastern Cooperative Oncology Group (ECOG) 0-1 - Have an acceptable hematological status - Have acceptable liver function - Have an acceptable coagulation status - Have acceptable renal function Exclusion Criteria: - Have uncontrolled intercurrent illness, including but not limited to: - Ongoing or active infection requiring intravenous treatment with antiinfective therapy - Symptomatic congestive heart failure (Grade III or IV as classified by the New York Heart Association), unstable angina pectoris or cardiac arrhythmia - Uncontrolled hypertension defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg, despite optimal medical management - Ongoing or recent evidence of autoimmune disease - History of irAEs that led to prior checkpoint treatment discontinuation - Prior history of myositis, Guillain-Barré syndrome, or myasthenia gravis of any grade - History of chronic liver disease or evidence of hepatic cirrhosis - History of non-infectious pneumonitis that has 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 GEN1046 - Serious, non-healing wound, skin ulcer (of any grade), or bone fracture - Any history of intracerebral arteriovenous malformation, cerebral aneurysm, new (younger than 6 months) or progressive brain metastases or stroke - Prior therapy: - Radiotherapy: Radiotherapy within 14 days prior to first GEN1046 administration. Palliative radiotherapy will be allowed. - Treatment with an anti-cancer agent (within 28 days or after at least 5 half-lives of the drug, whichever is shorter), prior to GEN1046 administration. Accepted exceptions are bisphosphonates (e.g., pamidronate, zoledronic acid, etc.) and denosumab - Toxicities from previous anti-cancer therapies that have not adequately resolved


Mayo Clinic in Arizona
Status: ACTIVE


New Haven
Yale University
Status: ACTIVE


Mayo Clinic in Florida
Status: ACTIVE


Emory University Hospital / Winship Cancer Institute


Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: ACTIVE


Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE


Mayo Clinic in Rochester
Status: ACTIVE


Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: ACTIVE

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center


Case Comprehensive Cancer Center
Status: ACTIVE
Ohio State University Comprehensive Cancer Center

The trial is an open-label, multi-center safety trial of GEN1046. The trial consists of two

parts, a dose escalation part (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.

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization

  • Primary ID GCT1046-01
  • Secondary IDs NCI-2020-03735
  • ID NCT03917381