A Trial to Evaluate the Safety of GEN1046 in Patients with Malignant Solid Tumors

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria - 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.

Inclusin Criteria - 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

Inclusion Criteria - 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Cassandra Moore, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Ashish Chintakuntlawar, M.B.B.S., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Yanyan Lou, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20490430

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