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Monoclonal Antibodies

GEN3017 for Lymphoma

Phase 1 & 2

Recruiting

Research Sponsored by Genmab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial will test a new drug for lymphoma in people who have already had treatment. All participants will receive the drug and no one will get a placebo.

Who is the study for?

This trial is for adults with relapsed or refractory CD30-expressing Hodgkin and Non-Hodgkin Lymphomas, who have at least one measurable lesion. Participants should be in good physical condition (ECOG score 0-1) and not have received certain recent treatments like chemotherapy, major surgery, or investigational drugs.Check my eligibility

What is being tested?

The trial tests GEN3017 as a solo treatment to see how safe it is and how well it works against lymphoma. It's given through under-the-skin injections. Everyone in the study will receive this active drug; there's no placebo group.See study design

What are the potential side effects?

Possible side effects of GEN3017 are not specified here but generally could include reactions at the injection site, immune system responses, fatigue, allergic reactions, and other impacts on organ function based on its pharmacological class.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is a relapsed or refractory classical Hodgkin lymphoma or T-cell lymphoma.

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I have at least one tumor that can be measured on scans.

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My tumor biopsy shows CD30-positivity.

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I am over 18 and can care for myself with minimal assistance, or I am 16-18 with a good level of activity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose Escalation Part: Number of Participants with Adverse Events (AEs)

Dose Escalation Part: Number of Participants with Dose Limiting Toxicities (DLTs)

Expansion Part: Objective Response Rate (ORR)

Secondary outcome measures

Dose Escalation and Expansion Part: Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of GEN3017

Dose Escalation and Expansion Part: Area Under the Concentration-time Curve (AUC) From Time Zero to Last Quantifiable Sample (AUClast) of GEN3017

Dose Escalation and Expansion Part: Duration of Response (DOR)

+13 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: R/R CD30+ cHL CohortExperimental Treatment1 Intervention

Group II: R/R CD30+ TCL CohortExperimental Treatment1 Intervention

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

GenmabLead Sponsor

56 Previous Clinical Trials

11,992 Total Patients Enrolled

Study OfficialStudy DirectorGenmab

9 Previous Clinical Trials

2,389 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is this experiment limited to?

"Affirmative. According to information on clinicaltrials.gov, this research is currently open for recruitment and was initially posted on September 21st 2023 with a recent update of September 25th 2023. The study requires the enrollment of 240 participants from 1 site."

Answered by AI

Are there vacancies available for prospective participants in this research?

"Affirmative, clinicaltrials.gov data shows that this trial is currently recruiting participants. The initial posting date was September 21st 2023 and the latest update happened on September 25th of the same year. This experiment requires 240 subjects to be recruited from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma

2023. "A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06018129.