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Brief Title: A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma
Official Title: A Phase 1/2a, Open-Label, Dose Escalation Trial of GEN3017 With Expansion Cohorts in Relapsed or Refractory CD30+ Classical Hodgkin Lymphoma and CD30+ Non-Hodgkin Lymphoma
Study ID: NCT06018129
Brief Summary: 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.
Detailed Description: 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).
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope, Duarte, California, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Washington University, Saint Louis, Missouri, United States
University of Texas M. D. Anderson Cancer Center, Houston, Texas, United States
Peter MacCallum Cancer Institute trading as Peter MacCallum Cancer Centre, Melbourne, , Australia
Name: Study Official
Affiliation: Genmab
Role: STUDY_DIRECTOR