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About
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:
Participation in the trial will require visits to the site. All participants will receive active drug; no one will be given placebo.
Full description
The trial is a first-in-human (FIH) open-label, multicenter, multinational safety trial.
The dose escalation will evaluate different dose levels by assessing safety, tolerability, and early efficacy signals to determine the expansion dose(s) of GEN1057 as monotherapy, as well as characterizing the pharmacokinetic (PK) profile and immunogenicity in participants with malignant solid tumors who have metastatic or advanced disease.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
Key Exclusion Criteria:
Has been exposed to any of the following prior therapies/treatments within the specified timeframes:
Has clinically significant toxicities from previous anticancer therapies that have not resolved to baseline levels or to grade 1, except for anorexia, hyperthyroidism, hypothyroidism, and peripheral neuropathy, which must have recovered to ≤ grade 2. There is no limitation for alopecia and hearing impairment from previous therapies.
Has known, symptomatic brain metastases. Asymptomatic brain metastases are allowed provided that they have been treated, have been stable for >28 days as documented by radiographic imaging, and do not require prolonged (>14 days) systemic corticosteroid therapy.
Has a past or current malignancy other than inclusion diagnosis.
Note: Other protocol-defined inclusion and exclusion criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
45 participants in 1 patient group
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Central trial contact
Genmab Trial Information
Data sourced from clinicaltrials.gov
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