Trial to Assess the Safety and Antitumor Activity of GEN1057 in Malignant Solid Tumors
Trial Parameters
Brief Summary
The purpose of this trial is to study the antibody GEN1057 when used as a single agent for the treatment of certain types of cancer. Trial details include: * The trial duration for an individual participant will be up to approximately 11 months. * The treatment duration for an individual participant will be up to approximately 4 months (the duration of treatment may vary for each participant) and the follow-up duration for an individual participant will be approximately 6 months. Participation in the trial will require visits to the site. All participants will receive active drug; no one will be given placebo.
Eligibility Criteria
Key Inclusion Criteria: * Advanced and/or metastatic malignant solid tumors, who have progressed on standard of care therapy for whom there is no available standard therapy likely to provide clinical benefit, or who are not candidates for available therapy, and for whom experimental therapy with GEN1057 may be beneficial, in the opinion of the investigator. * Be at least 18 (or the legal age of consent in the jurisdiction in which the trial is taking place) years of age. * Have measurable disease according to RECIST v1.1. * Have Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1 at screening and on C1D1 pretreatment. Note: If screening ECOG PS is assessed within 3 days prior to C1D1, ECOG PS does not need to be reassessed at C1D1. * Have a life expectancy of ≥3 months. Key Exclusion Criteria: * Has been exposed to any of the following prior therapies/treatments within the specified timeframes: * Treatment with an investigational anticancer agent within 28 days or