GEN1046 Safety Trial in Patients With Malignant Solid Tumors

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 652

Inclusion Criteria

For Dose Escalation:
• Measurable disease according to RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) 0-1.
• Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
• Subjects must 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 Dose Expansion:
• Measurable disease according to RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) 0-1.
• Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
• Subjects must have histologically or cytological confirmed diagnosis of relapsed or refractory, advanced and/or metastatic NSCLC, EC, UC, TNBC, SCCHN, or cervical cancer who are no longer candidates for or refuse standard therapy (if subjects had access and were eligible for the respective treatments).

For detailed inclusion criteria (with specific criteria for expansion cohorts) please refer to the Clinical Trial Protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 456
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 196

Exclusion Criteria

• Subject has uncontrolled intercurrent illness, including but not limited to:
• Ongoing or active infection requiring intravenous treatment with anti-infective therapy that has been administered less than 2 weeks prior to first dose, or any ongoing systemic inflammatory condition requiring further diagnostic work-up or management during screening.
• 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 (within 1 year) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs).
• Subjects with a history of grade 3 or higher irAEs that led to treatment discontinuation of a prior immunotherapy treatment should be excluded. Subjects with irAEs below grade 3 that led to discontinuation should be discussed with the sponsor.
• Subjects with a prior history of myositis, Guillain-Barré syndrome, or myasthenia gravis of any grade are excluded.
• 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.
• All subjects should undergo a computed tomography (CT) scan or magnetic resonance imaging (MRI) of the brain to document new or existing CNS lesions.
a. Any history of intracerebral arteriovenous malformation, cerebral aneurysm, spinal cord compression (from disease), carcinomatous meningitis or stroke (within the last 6 months).
Transient ischemic attack > 1 month prior to screening is allowed.
b. Subjects with newly identified or known unstable or symptomatic CNS metastases will be excluded. Subjects with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 28 days from the radiological diagnosis of brain metastases by repeat imaging (that should be performed during trial screening). Subjects should be clinically stable and should not be undergoing acute corticosteroid therapy or steroid taper or have received stereotactic radiation or whole-brain radiation within 14 days prior to C1D1. Chronic steroid therapy is acceptable provided that the dose is stable for the last 14 days prior to C1D1 (= 10 mg prednisone daily or equivalent). Note that radiotherapy is not allowed 14 days prior to first dosing and that the irradiated lesion cannot be used for efficacy assessment.
• Prior therapy:
• Radiotherapy within 14 days prior to first GEN1046 administration or received lung radiation therapy of >30 Gy within 6 months of the first dose of trial treatment. Subjects must have recovered from all radiation related toxicities, not require corticosteroids, and not have had radiation pneumonitis. Note: 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 e

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Updated 12/19/2023

GEN1046 Safety Trial in Patients With Malignant Solid Tumors

Recruitment & Eligibility

Study & Design

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