BridgeMD
A first-in-human trial of safety and efficacy of GEN3017 in subjects with Hodgkin lymphoma or non-Hodgkin lymphoma
EU CTIS ID: 2023-503348-15-00
What this study is testing
Dose escalation: 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 2.Evaluate the safety and tolerability of GEN3017 Expansion: 1.Assess the preliminary anti-tumor activity of GEN3017
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United States; Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.