First-in-Human, Open-label, Dose-Escalation Trial With an Expansion Cohort to Evaluate the Safety of GEN1053 as Monotherapy in Subjects With Malignant Solid Tumors

  • End date
    Jul 1, 2027
  • participants needed
  • sponsor
Updated on 20 October 2022


The drug that will be investigated in the study is GEN1053. GEN1053 is an antibody designed to (re)activate and increase antitumor immunity.

Since this is the first study of GEN1053 in humans, the main purpose is to evaluate safety. Besides safety, the study will determine the recommended GEN1053 dose to be tested in a larger group of participants and assess preliminary clinical activity of GEN1053.

GEN1053 will be studied in a broad group of cancer patients, having different kinds of solid tumors. All participants will get GEN1053. The study consists of two parts: Part 1 tests increasing doses of GEN1053 ("escalation"), followed by Part 2 which tests the recommended phase 2 dose GEN1053 dose from Part 1 ("expansion").


The trial is a First in Human open-label, multicenter, multinational safety trial in participants with non-central nervous system (non-CNS) metastatic or advanced malignant solid tumors for whom there is no available standard therapy likely to confer clinical benefit, evaluating the safety, tolerability, preliminary antitumor activity, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of GEN1053.

The trial will be conducted as follows:

  • The Dose Escalation part (Part 1) will explore the safety of escalating doses of GEN1053 as monotherapy (phase 1)
  • The Expansion part (Part 2) is planned to provide additional safety and initial antitumor activity information of the Recommended Phase 2 dose (RP2D) for GEN1053 monotherapy in selected tumor indications, as well as more detailed data related to the mode of action (MoA).

Condition Solid Tumor, Adult
Treatment GEN1053
Clinical Study IdentifierNCT05435339
Last Modified on20 October 2022


Yes No Not Sure

Inclusion Criteria

For both the Dose Escalation and Expansion parts
Be ≥18 years of age
Have measurable disease according to RECIST 1.1
Provide all pre-baseline scans since failure of last prior therapy (ie radiographic PD), if available
Have Eastern Cooperative Oncology Group performance status ≤1
Have organ and bone marrow function as follows
Bone marrow / hematological function
Absolute neutrophil count (ANC) ≥1.5×10^9/L
Hemoglobin ≥9.0 g/dL
Platelet count ≥150×10^9/L
Liver function
Total bilirubin ≤ upper limit of normal (ULN)
Alanine aminotransferase ≤1.5×ULN
Aspartate aminotransferase ≤1.5×ULN
Albumin ≥30 g/L
Coagulation status
Prothrombin time (PT)/International normalized ratio ≤1.5
Activated partial thromboplastin time (aPTT) ≤1.5×ULN
Renal function: Glomerular filtration rate ≥45 mL/min/1.73 m², according to the abbreviated Modification of Diet in Renal Disease equation
For Monotherapy Dose Escalation (phase 1) only
Subjects with histologically or cytologically confirmed non-CNS solid tumors that are metastatic or advanced
Subjects who have progressed on standard of care therapy or for whom there is no available standard therapy likely to provide clinical benefit, or who are not candidates for or refuse such available therapy, and for whom, in the opinion of the investigator, experimental therapy with GEN1053 may be beneficial
Fresh biopsies mandatory for all patients in Monotherapy Dose Escalation
For the Expansion part Only
•Subjects with histologically or cytologically confirmed diagnosis of recurrent
unresectable or metastatic HNSCC, who have progressed on standard of care therapy or do not
have any further available standard therapy or are not candidates for or refuse standard
therapy (if subjects had access), and for whom experimental therapy with GEN1053 may be
beneficial in the opinion of the investigator

Exclusion Criteria

Has uncontrolled intercurrent illness, including but not limited to
Ongoing or active infection requiring IV treatment with anti-infective therapy
administered less than 2 weeks prior to first dose
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 mm Hg and/or
diastolic blood pressure ≥100 mm Hg, despite optimal medical management
Prolonged QTc interval at baseline of ≥470 milliseconds using Fridericia's QT
correction formula
Ongoing or recent (within 1 year) evidence of significant autoimmune disease that
required treatment with systemic immunosuppressive treatments, which may suggest
risk for irAEs
History of grade 3 or higher irAEs that led to treatment discontinuation of a
History of chronic liver disease or evidence of hepatic cirrhosis
Evidence of interstitial lung disease
Ongoing pneumonitis or history of non-infectious pneumonitis that has required
Known platelet function defects
Prior therapy
Radiotherapy within 14 days prior to first GEN1053 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 GEN1053 administration
Subject with a condition requiring systemic treatment with either corticosteroids
(>10 mg daily prednisone equivalent) or other immunosuppressive medications
within 14 days of first treatment. Inhaled or topical steroids, and adrenal or
pituitary replacement steroid > 10 mg daily prednisone equivalent, are permitted
in the absence of active autoimmune disease
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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