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

Study Identifier:
GCT1053-01
CT.gov Identifier:
NCT05435339
EudraCT Identifier:
2021-006692-42
EU Trial (CTIS) Number:
2022-502419-12-00
Study Contact Information:
(210) 593-5651 or [email protected]
Terminated/Withdrawn

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Study Summary

To evaluate the safety, tolerability, preliminary antitumor activity, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of GEN1053 in patients with Malignant Solid Tumors

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Solid Tumor
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I/II
Sex
Female & Male
Age
18+ years
Study Drug
Drug: Experimental: GEN1053 Monotherapy
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Drug: Biological: GEN1053
Study Status
Indicates the current recruitment status or the expanded access status
Terminated/Withdrawn

Requirements information
Inclusion criteria
  • For both the Dose Escalation and Expansion parts:
  • Be >or= 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
  • Have organ and bone marrow function as follows:
  • Bone marrow / hematological function:
  • Absolute neutrophil count (ANC) >or=1.5×10^9/L
  • Hemoglobin >or= 9.0 g/dL
  • Platelet count >or= 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
  • Activated partial thromboplastin time (aPTT)
  • Renal function: Glomerular filtration rate >or= 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 >or= 160 mm Hg and/or diastolic blood pressure ≥100 mm Hg, despite optimal medical management.
  • Prolonged QTc interval at baseline of >or= 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 CPI.
  • 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 steroids.
  • 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

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (CIOCC)
Madrid, Spain, 28050
Investigator
Emiliano Calvo
Status
Terminated/Withdrawn
Condition(s) Treated at Site
Solid Tumor