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A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma
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.
Study details:
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).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 16 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-09-21
Primary completion: 2029-12-31
Study completion finish: 2032-12-31
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT06018129
Intervention or treatment
BIOLOGICAL: GEN3017
Conditions
- • Classical Hodgkin Lymphoma
- • Non-Hodgkin Lymphoma
Find a site
Closest Location:
Peter MacCallum Cancer Institute trading as Peter MacCallum Cancer Centre
Research sites nearby
Select from list below to view details:
Peter MacCallum Cancer Institute trading as Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: R/R CD30+ cHL Cohort
| BIOLOGICAL: GEN3017
|
EXPERIMENTAL: R/R CD30+ TCL Cohort
| BIOLOGICAL: GEN3017
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Dose Escalation Part: Number of Participants with Dose Limiting Toxicities (DLTs) | All AEs including DLTs will be graded for severity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), version (v) 5.0 unless otherwise specified. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be evaluated according to the American society for transplantation and cellular therapy (ASTCT) criteria. Clinical tumor lysis syndrome (CTLS) will be evaluated according to the Cairo-Bishop classification. | During the first cycle (Cycle length = 21 days) |
| Dose Escalation Part: Number of Participants with Adverse Events (AEs) | Not Specified | From baseline up to 60 days after last dose of study drug or until study completion or participant withdrawal (up to 5 years) |
| Expansion Part: Objective Response Rate (ORR) | The ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per Lugano criteria assessed by an independent review committee (IRC). | Up to 5 years |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Dose Escalation and Expansion Part: Maximum (Peak) Plasma Concentration (Cmax) of GEN3017 | Not Specified | Predose and postdose at multiple timepoints at end of each cycle up to end of treatment (Cycle length =21 days) |
| Dose Escalation and Expansion Part: Time to Reach Cmax (Tmax) of GEN3017 | Not Specified | Predose and postdose at multiple timepoints at end of each cycle up to end of treatment (Cycle length = 21 days) |
| Dose Escalation and Expansion Part: Pre-dose (Trough) concentration (Ctrough) of GEN3017 | Not Specified | Predose and postdose at multiple timepoints at end of each cycle up to end of treatment (Cycle length = 21 days) |
| Dose Escalation and Expansion Part: Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of GEN3017 | Not Specified | Predose and postdose at multiple timepoints at end of each cycle up to end of treatment (Cycle length = 21 days) |
| Dose Escalation and Expansion Part: Area Under the Concentration-time Curve (AUC) From Time Zero to Last Quantifiable Sample (AUClast) of GEN3017 | Not Specified | Predose and postdose at multiple timepoints at end of each cycle up to end of treatment (Cycle length = 21 days) |
| Dose Escalation and Expansion Part: Elimination Half-life (T1/2) of GEN3017 | Not Specified | Predose and postdose at multiple timepoints at end of each cycle up to end of treatment (Cycle length = 21 days) |
| Dose Escalation and Expansion Part: Total Body Clearance (CL) of Drug From Plasma of GEN3017 | Not Specified | Predose and postdose at multiple timepoints at end of each cycle up to end of treatment (Cycle length = 21 days) |
| Dose Escalation and Expansion Part: Volume of distribution (Vd) of GEN3017 | Not Specified | Predose and postdose at multiple timepoints at end of each cycle up to end of treatment (Cycle length = 21 days) |
| Dose Escalation and Expansion Part: Number of Participants with Anti-drug Antibodies (ADA) to GEN3017 | Serum samples will be screened for ADAs binding to GEN3017 and the titer of confirmed positive samples will be reported. | Predose at multiple timepoints of each cycle up to end of treatment (Cycle length = 21 days) |
| Dose Escalation and Expansion Part: Objective Response Rate (ORR) | The ORR is defined as the percentage of participants with a BOR of CR or PR per Lugano criteria based on investigator assessment. | Up to 5 years |
| Dose Escalation and Expansion Part: Duration of Response (DOR) | DOR is defined as the time from the first documentation of response (CR or PR) to the date of progressive disease or death, whichever occurs earlier per Lugano criteria based on investigator and IRC assessment (expansion only). | Up to 5 years |
| Dose Escalation and Expansion Part: Time to Response (TTR) | TTR is defined as the time from Cycle 1 Day 1 to first documentation of objective response in participants achieving PR or CR per Lugano criteria based on investigator and IRC assessment (expansion only). | Up to 5 years |
| Expansion Part: Complete Response Rate (CRR) | CRR is defined as the number of participants with CR per Lugano criteria based on investigator and IRC assessment. | Up to 5 years |
| Expansion Part: Progression Free Survival (PFS) | PFS is defined as the time from Cycle 1 Day 1 to first documented progressive disease or death due to any cause, whichever occurs earlier per Lugano criteria based on investigator and IRC assessment. | Up to 5 years |
| Expansion Part: Overall Survival (OS) | OS is defined as the time from Cycle 1 Day 1 to the date of death due to any cause. | Up to 5 years |
| Expansion Part: Number of Participants with AEs and Serious Adverse Events (SAEs) | Not Specified | From first dose until the end of the safety follow-up period (60 days after last dose) up to 5 years |
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