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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06018129




Registration number
NCT06018129
Ethics application status
Date submitted
25/08/2023
Date registered
30/08/2023
Date last updated
5/11/2024

Titles & IDs
Public title
A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma
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
Secondary ID [1] 0 0
2023-503348-15-00
Secondary ID [2] 0 0
GCT3017-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Classical Hodgkin Lymphoma 0 0
Non-Hodgkin Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Hodgkin's

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - GEN3017

Experimental: R/R CD30+ cHL Cohort -

Experimental: R/R CD30+ TCL Cohort -


Treatment: Other: GEN3017
Subcutaneous injection
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose Escalation Part: Number of Participants with Dose Limiting Toxicities (DLTs)
Timepoint [1] 0 0
During the first cycle (Cycle length = 21 days)
Primary outcome [2] 0 0
Dose Escalation Part: Number of Participants with Adverse Events (AEs)
Timepoint [2] 0 0
From baseline up to 60 days after last dose of study drug or until study completion or participant withdrawal (up to 5 years)
Primary outcome [3] 0 0
Expansion Part: Objective Response Rate (ORR)
Timepoint [3] 0 0
Up to 5 years
Secondary outcome [1] 0 0
Dose Escalation and Expansion Part: Maximum (Peak) Plasma Concentration (Cmax) of GEN3017
Timepoint [1] 0 0
Predose and postdose at multiple timepoints at end of each cycle up to end of treatment (Cycle length =21 days)
Secondary outcome [2] 0 0
Dose Escalation and Expansion Part: Time to Reach Cmax (Tmax) of GEN3017
Timepoint [2] 0 0
Predose and postdose at multiple timepoints at end of each cycle up to end of treatment (Cycle length = 21 days)
Secondary outcome [3] 0 0
Dose Escalation and Expansion Part: Pre-dose (Trough) concentration (Ctrough) of GEN3017
Timepoint [3] 0 0
Predose and postdose at multiple timepoints at end of each cycle up to end of treatment (Cycle length = 21 days)
Secondary outcome [4] 0 0
Dose Escalation and Expansion Part: Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of GEN3017
Timepoint [4] 0 0
Predose and postdose at multiple timepoints at end of each cycle up to end of treatment (Cycle length = 21 days)
Secondary outcome [5] 0 0
Dose Escalation and Expansion Part: Area Under the Concentration-time Curve (AUC) From Time Zero to Last Quantifiable Sample (AUClast) of GEN3017
Timepoint [5] 0 0
Predose and postdose at multiple timepoints at end of each cycle up to end of treatment (Cycle length = 21 days)
Secondary outcome [6] 0 0
Dose Escalation and Expansion Part: Elimination Half-life (T1/2) of GEN3017
Timepoint [6] 0 0
Predose and postdose at multiple timepoints at end of each cycle up to end of treatment (Cycle length = 21 days)
Secondary outcome [7] 0 0
Dose Escalation and Expansion Part: Total Body Clearance (CL) of Drug From Plasma of GEN3017
Timepoint [7] 0 0
Predose and postdose at multiple timepoints at end of each cycle up to end of treatment (Cycle length = 21 days)
Secondary outcome [8] 0 0
Dose Escalation and Expansion Part: Volume of distribution (Vd) of GEN3017
Timepoint [8] 0 0
Predose and postdose at multiple timepoints at end of each cycle up to end of treatment (Cycle length = 21 days)
Secondary outcome [9] 0 0
Dose Escalation and Expansion Part: Number of Participants with Anti-drug Antibodies (ADA) to GEN3017
Timepoint [9] 0 0
Predose at multiple timepoints of each cycle up to end of treatment (Cycle length = 21 days)
Secondary outcome [10] 0 0
Dose Escalation and Expansion Part: Objective Response Rate (ORR)
Timepoint [10] 0 0
Up to 5 years
Secondary outcome [11] 0 0
Dose Escalation and Expansion Part: Duration of Response (DOR)
Timepoint [11] 0 0
Up to 5 years
Secondary outcome [12] 0 0
Dose Escalation and Expansion Part: Time to Response (TTR)
Timepoint [12] 0 0
Up to 5 years
Secondary outcome [13] 0 0
Expansion Part: Complete Response Rate (CRR)
Timepoint [13] 0 0
Up to 5 years
Secondary outcome [14] 0 0
Expansion Part: Progression Free Survival (PFS)
Timepoint [14] 0 0
Up to 5 years
Secondary outcome [15] 0 0
Expansion Part: Overall Survival (OS)
Timepoint [15] 0 0
Up to 5 years
Secondary outcome [16] 0 0
Expansion Part: Number of Participants with AEs and Serious Adverse Events (SAEs)
Timepoint [16] 0 0
From first dose until the end of the safety follow-up period (60 days after last dose) up to 5 years

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.

Key
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2032
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Institute trading as Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genmab
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT06018129
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Official
Address 0 0
Genmab
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Genmab Trial Information
Address 0 0
Country 0 0
Phone 0 0
+4570202728
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06018129