Clinical Trials

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:  

• • 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.

Eligibility last updated 12/22/21. Questions regarding updates should be directed to the study team contact.