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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06018129
Registration number
NCT06018129
Ethics application status
Date submitted
25/08/2023
Date registered
30/08/2023
Date last updated
4/06/2024
Titles & IDs
Public title
A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma
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Scientific 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
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Secondary ID [1]
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2023-503348-15-00
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Secondary ID [2]
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GCT3017-01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Classical Hodgkin Lymphoma
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Non-Hodgkin Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
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Hodgkin's
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - GEN3017
Experimental: R/R CD30+ cHL Cohort -
Experimental: R/R CD30+ TCL Cohort -
Other interventions: GEN3017
Subcutaneous injection
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Dose Escalation Part: Number of Participants with Dose Limiting Toxicities (DLTs)
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Assessment method [1]
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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.
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Timepoint [1]
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During the first cycle (Cycle length = 21 days)
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Primary outcome [2]
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Dose Escalation Part: Number of Participants with Adverse Events (AEs)
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Assessment method [2]
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Timepoint [2]
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From baseline up to 60 days after last dose of study drug or until study completion or participant withdrawal (up to 5 years)
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Primary outcome [3]
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Expansion Part: Objective Response Rate (ORR)
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Assessment method [3]
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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).
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Timepoint [3]
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Up to 5 years
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Secondary outcome [1]
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Dose Escalation and Expansion Part: Maximum (Peak) Plasma Concentration (Cmax) of GEN3017
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Assessment method [1]
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Timepoint [1]
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Predose and postdose at multiple timepoints at end of each cycle up to end of treatment (Cycle length =21 days)
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Secondary outcome [2]
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Dose Escalation and Expansion Part: Time to Reach Cmax (Tmax) of GEN3017
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Assessment method [2]
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Timepoint [2]
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Predose and postdose at multiple timepoints at end of each cycle up to end of treatment (Cycle length = 21 days)
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Secondary outcome [3]
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Dose Escalation and Expansion Part: Pre-dose (Trough) concentration (Ctrough) of GEN3017
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Assessment method [3]
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Timepoint [3]
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Predose and postdose at multiple timepoints at end of each cycle up to end of treatment (Cycle length = 21 days)
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Secondary outcome [4]
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Dose Escalation and Expansion Part: Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of GEN3017
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Assessment method [4]
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Timepoint [4]
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Predose and postdose at multiple timepoints at end of each cycle up to end of treatment (Cycle length = 21 days)
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Secondary outcome [5]
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Dose Escalation and Expansion Part: Area Under the Concentration-time Curve (AUC) From Time Zero to Last Quantifiable Sample (AUClast) of GEN3017
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Assessment method [5]
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Timepoint [5]
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Predose and postdose at multiple timepoints at end of each cycle up to end of treatment (Cycle length = 21 days)
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Secondary outcome [6]
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Dose Escalation and Expansion Part: Elimination Half-life (T1/2) of GEN3017
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Assessment method [6]
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Timepoint [6]
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Predose and postdose at multiple timepoints at end of each cycle up to end of treatment (Cycle length = 21 days)
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Secondary outcome [7]
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Dose Escalation and Expansion Part: Total Body Clearance (CL) of Drug From Plasma of GEN3017
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Assessment method [7]
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Timepoint [7]
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Predose and postdose at multiple timepoints at end of each cycle up to end of treatment (Cycle length = 21 days)
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Secondary outcome [8]
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Dose Escalation and Expansion Part: Volume of distribution (Vd) of GEN3017
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Assessment method [8]
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Timepoint [8]
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Predose and postdose at multiple timepoints at end of each cycle up to end of treatment (Cycle length = 21 days)
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Secondary outcome [9]
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Dose Escalation and Expansion Part: Number of Participants with Anti-drug Antibodies (ADA) to GEN3017
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Assessment method [9]
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Serum samples will be screened for ADAs binding to GEN3017 and the titer of confirmed positive samples will be reported.
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Timepoint [9]
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Predose at multiple timepoints of each cycle up to end of treatment (Cycle length = 21 days)
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Secondary outcome [10]
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Dose Escalation and Expansion Part: Objective Response Rate (ORR)
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Assessment method [10]
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The ORR is defined as the percentage of participants with a BOR of CR or PR per Lugano criteria based on investigator assessment.
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Timepoint [10]
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Up to 5 years
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Secondary outcome [11]
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Dose Escalation and Expansion Part: Duration of Response (DOR)
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Assessment method [11]
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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).
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Timepoint [11]
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Up to 5 years
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Secondary outcome [12]
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Dose Escalation and Expansion Part: Time to Response (TTR)
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Assessment method [12]
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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).
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Timepoint [12]
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Up to 5 years
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Secondary outcome [13]
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Expansion Part: Complete Response Rate (CRR)
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Assessment method [13]
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CRR is defined as the number of participants with CR per Lugano criteria based on investigator and IRC assessment.
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Timepoint [13]
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Up to 5 years
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Secondary outcome [14]
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Expansion Part: Progression Free Survival (PFS)
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Assessment method [14]
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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.
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Timepoint [14]
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Up to 5 years
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Secondary outcome [15]
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Expansion Part: Overall Survival (OS)
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Assessment method [15]
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OS is defined as the time from Cycle 1 Day 1 to the date of death due to any cause.
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Timepoint [15]
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Up to 5 years
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Secondary outcome [16]
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Expansion Part: Number of Participants with AEs and Serious Adverse Events (SAEs)
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Assessment method [16]
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Timepoint [16]
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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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Eligibility
Key inclusion criteria
Key
Dose Escalation Part:
1. Must be at least 18 years of age. For participants in the R/R cHL Cohort in the United
States (US) and Australia, must be at least 16 years of age.
2. Histologically confirmed R/R cHL or R/R TCL.
3. 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.
4. 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.
5. Confirmed CD30-positivity in tumor biopsy prior to the first dose of GEN3017.
6. R/R cHL Cohort:
- 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.
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Primary central nervous system (CNS) tumor or known CNS involvement.
2. Received prior investigational CD30-targeting therapy (except brentuximab vedotin).
3. Autologous hematopoietic stem cell transplant (HSCT) within 60 days (applies to both
cHL and TCL). Allogeneic HSCT within 90 days (applies to cHL) prior to the first dose
of GEN3017.
4. Chemotherapy within 2 weeks or major surgery within 4 weeks prior to the first dose of
GEN3017.
5. Curative radiotherapy within 4 weeks or palliative radiotherapy within 2 weeks prior
to the first dose of GEN3017.
6. 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.
7. Prior treatment with live, attenuated vaccines within 30 days prior to the first dose
of GEN3017.
8. Receiving immunosuppressive drugs or systemic corticosteroids such as prednisone at
doses >25 milligrams (mg) daily or its equivalent within 14 days prior to the first
dose of GEN3017.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/09/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2032
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Actual
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Sample size
Target
240
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Peter MacCallum Cancer Institute trading as Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Massachusetts
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Country [3]
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United States of America
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State/province [3]
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Missouri
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Country [4]
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United States of America
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State/province [4]
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Texas
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Genmab
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06018129
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Study Official
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Address
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Genmab
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Genmab Trial Information
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Address
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Country
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Phone
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+4570202728
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06018129
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