GEN1046 Safety Trial in Patients With Malignant Solid Tumors

Phase 1

Recruiting

• Conditions: Malignant solid tumors: endometrial carcinoma (EC), urothelial carcinoma (UC), triple-negative breast cancer (TNBC), squamous cell carcinoma of the head and neck (SCCHN), or cervical cancer.; MedDRA version: 21.1Level: LLTClassification code: 10065143Term: Malignant solid tumour Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-509059-15-00
• Lead Sponsor: Genmab A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-14
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 427

Inclusion Criteria

For Dose Escalation: • Measurable disease; • 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 • 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.

Exclusion Criteria

• Subject has uncontrolled intercurrent illness, including but not limited to: • Ongoing or active infection requiring intravenous treatment with antiinfective therapy that has been administered <2 weeks prior to first dose; • Symptomatic congestive heart failure; • Uncontrolled hypertension defined as systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg; • 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 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; • History of organ allograft; • Serious, non-healing wound, skin ulcer, 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. For detailed exclusion criteria (with specific criteria for expansion cohorts) please refer to the Clinical Trial Protocol., • 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; • 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; • Subjects who discontinued treatment due to disease progression within the first 6 weeks of a CPI containing treatment; • Prior treatment with a 4-1BB (CD137) targeted agent; • Prior treatment with a T-cell agonist or anti-CTLA-4 targeted agent within 12 weeks prior to the initiation of treatment; • Toxicities from previous anti-cancer therapies; For detailed exclusion criteria (with specific criteria for expansion cohorts) please refer to the Clinical Trial Protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified