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Phase I

A First-in-Human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1042 in Subjects With Malignant Solid Tumors

  • Study HIC#:2000027214
  • Last Updated:07/12/2021

To evaluate the safety of GEN1042 in patients with malignant solid tumors.

  • Start Date10/08/2020
  • End Date12/01/2020

Trial Purpose and Description

The trial is an open-label, multi-center, safety trial of GEN1042. The trial consists of two parts, a dose escalation (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.

Eligibility Criteria

Inclusion Criteria:

Dose Escalation:

• Histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is no available standard therapy.

Expansion:

• Histologically or cytologically confirmed diagnosis of relapsed or refractory, advanced and/or metastatic melanoma, NSCLC, or CRC who are not anymore candidates for standard therapy

Dose Escalation and Expansion:

  • Measurable disease according to RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) 0-1
  • Acceptable bone marrow and hematological, liver and renal functions
  • Acceptable coagulation status

Exclusion Criteria:

Uncontrolled intercurrent illness, including but not limited to:

  • Ongoing or active infection treated with intravenous anti-infective therapy less than 2 weeks prior to first dose
  • Symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
  • Uncontrolled hypertension despite optimal medical management.
  • Evidence of significant autoimmune disease suggesting risk for immune-related adverse events (irAEs).
  • History of irAEs that led to treatment discontinuation of prior ICP inhibitor
  • • History of chronic liver disease or evidence of hepatic cirrhosis.
  • History of non-infectious pneumonitis that 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 GEN1042.
  • Serious, non-healing wound, skin ulcer (of any grade), or bone fracture.
  • Any history of intracerebral arteriovenous malformation, cerebral aneurysm, or progressive brain metastases or stroke.

Prior therapy:

  • Radiotherapy within 14 days prior to first GEN1042 administration
  • Treatment with an anti-cancer agent (within 21 days or after at least 5 half-lives of the drug, whichever is shorter), prior to GEN1042 administration.
  • History of ≥ grade 3 allergic reactions to monoclonal antibody (mAb) therapy
  • Toxicities from previous anti-cancer therapies that have not resolved

Sub-Investigators

For more information about this study, contact: