A first-in-human trial of safety and efficacy of GEN3017 in subjects with Hodgkin lymphoma or non-Hodgkin lymphoma

Phase 1

• Conditions: Hodgkin lymphoma or non-Hodgkin lymphoma; MedDRA version: 20.0Level: HLGTClassification code: 10025322Term: Lymphomas non-Hodgkin's unspecified histology Class: 10029104; MedDRA version: 20.0Level: HLGTClassification code: 10025319Term: Lymphomas Hodgkin's disease Class: 10029104; Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2023-503348-15-00
• Lead Sponsor: Genmab A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-31
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Dose Escalation: Must be at least 18 years of age. For subjects in the R/R cHL Cohort in the United States (US) and Australia, must be at least 16 years of age., Histologically confirmed R/R cHL or R/R TCL., Participants must have at least 1 measurable lesion by fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT)- or magnetic resonance imaging (MRI)-defined anatomical tumor sites and a CT scan (or MRI) with involvement of =1 measurable nodal lesion and/or =1 measurable extranodal lesion., Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 for participants 18 years of age and above. For participants =16 and <18 years of age (US and Australia only), Karnofsky score of >60% per Karnofsky performance scale., Confirmed CD30-positivity in tumor biopsy prior to the first dose of GEN3017., R/R cHL Cohort in Dose Escalation:• Must have relapsed or progressive cHL after receiving at least 2 or 3 prior lines of therapy. OR • Refractory to the second line of therapy

Exclusion Criteria

Primary central nervous system (CNS) tumor or known CNS involvement., Received prior investigational CD30-targeting therapy., Autologous HSCT within 60 days prior to the first dose of GEN3017 or any prior allogeneic HSCT., Chemotherapy within 2 weeks or major surgery within 4 weeks prior to the first dose of GEN3017., Curative radiotherapy within 4 weeks or palliative radiotherapy within 2 weeks prior to the first dose of GEN3017., Treatment with an investigational drug within 4 weeks or 5 half-lives of the drug, whichever is shorter prior to the first dose of GEN3017 or currently receiving any other investigational agents., Prior treatment with live, attenuated vaccines within 30 days prior to the first dose of GEN3017., Receiving immunosuppressive drugs or systemic corticosteroids such as prednisone at doses >25 mg daily or its equivalent within 14 days prior to the first dose of GEN3017. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Dose escalation:<br>1.Determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) and recommended phase 2 dose (RP2D), or dose(s) to be studied in the expansion part<br><br>2.Evaluate the safety and tolerability of GEN3017<br><br>Expansion:<br>1.Assess the preliminary anti-tumor activity of GEN3017;Secondary Objective: Dose Escalation: Characterize the pharmacokinetic (PK) properties of GEN3017., Dose Escalation: Evaluate immunogenicity., Dose Escalation: Assess the preliminary anti-tumor activity of GEN3017, Expansion: Assess the anti-tumor activity and efficacy of GEN3017, Expansion: Evaluate safety and immunogenicity of GEN3017, Expansion: Characterize the PK of GEN3017;Primary end point(s): Dose Escalation: Incidence of dose-limiting toxicities (DLTs), Incidence and severity of adverse events (AEs), Expansion: ORR based on the Lugano criteria as assessed by independent review committee (IRC)