The purpose of this trial is to evaluate the safety, tolerability, immunogenicity,
pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of GEN3017 as a
monotherapy in participants with relapsed or refractory (R/R) CD30-expressing lymphomas.
GEN3017 will be administered via subcutaneous injections.
All participants will receive active drug; no one will be given placebo.
Additional locations may be listed on ClinicalTrials.gov for NCT06018129.
See trial information on ClinicalTrials.gov for a list of participating sites.
This multicenter trial will be conducted in 2 parts: Dose Escalation (phase 1) and
Expansion (phase 2a).
The Dose Escalation Part (phase 1) of the trial will evaluate dose-limiting toxicities
(DLTs) to determine the recommended phase 2 dose (RP2D), and if reached, the maximum
tolerated dose (MTD) for R/R CD30+ classical Hodgkin lymphoma (cHL) and R/R CD30+ T-cell
lymphoma (TCL), respectively.
The Expansion Part (phase 2a) will evaluate the anti-tumor activity of GEN3017 at the
RP2D and selected dosage(s) will be assessed together with safety, immunogenicity,
pharmacokinetics, and pharmacodynamics in R/R CD30+ cHL participants (including adults;
and adolescent and young adults) and in participants with selected R/R CD30+ TCL subtypes
(adults only).