Description:
The aim of this first-in-human trial is to characterize the safety, tolerability,
pharmacokinetic (PK), and pharmacodynamic characteristics of GEN3009 (DuoHexabody®-CD37) in
subjects with relapsed/refractory B-cell Non-Hodgkin Lymphoma (NHL).
Title
- Brief Title: First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas
- Official Title: Safety and Efficacy of GEN3009 (DuoHexaBody®-CD37) in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma - A First-in-Human, Open-label, Phase 1/2a Dose Escalation Trial With Dose Expansion Cohorts
Clinical Trial IDs
- ORG STUDY ID:
GCT3009-01
- NCT ID:
NCT04358458
Conditions
- B-cell Non-Hodgkin Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
GEN3009 | DuoHexaBody®-CD37 | Treatment Administered |
Purpose
The aim of this first-in-human trial is to characterize the safety, tolerability,
pharmacokinetic (PK), and pharmacodynamic characteristics of GEN3009 (DuoHexabody®-CD37) in
subjects with relapsed/refractory B-cell Non-Hodgkin Lymphoma (NHL).
Detailed Description
This trial is a first-in-human (FIH), open-label, multicenter trial to evaluate the safety,
tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of
GEN3009 in subjects with relapsed/refractory B-cell NHL (both aggressive and indolent
subtypes).
The trial will be conducted in 2 parts; Dose Escalation and Dose Expansion. In the Dose
Escalation part, GEN3009 will be administered by intravenous (IV) infusions at various dose
levels in 28-day cycles. Dose Limiting Toxicity (DLT) will be assessed during the first
treatment cycle and the Maximum Tolerated Dose (MTD) will be identified. Additional subjects
will be treated in the Dose Expansion at the Recommended Phase 2 Dose (RP2D).
Trial Arms
Name | Type | Description | Interventions |
---|
Treatment Administered | Experimental | | |
Eligibility Criteria
Inclusion Criteria:
1. Be at least 18 years of age.
2. Must sign an informed consent form prior to any screening procedures.
3. Has histologically or cytologically confirmed relapsed and/or refractory B-cell NHL
with no available standard therapy or is not a candidate for available standard
therapy, and for whom, in the opinion of the investigator, experimental therapy with
GEN3009 may be beneficial. All subjects must have received at least two prior lines of
systemic therapy.
4. Has one of the specified subtypes for B-cell NHL for the Dose Escalation and Dose
Expansion parts of the study.
5. Has measurable disease for B-cell NHL or has active disease for Chronic Lymphocytic
Leukemia (CLL).
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
7. Has adequate hepatic, renal, and bone marrow functions.
8. Before the first dose of GEN3009, during the trial, and for 12 months after the last
dose of GEN3009, a woman must be either not of childbearing potential or of
childbearing potential and practicing a highly effective method of birth control, and
must have a negative serum beta-human chorionic gonadotropin (beta-hCG) and urine
pregnancy test at screening.
9. A man who is sexually active with a woman of childbearing potential and has not had a
vasectomy must agree to use a barrier method of birth control.
Exclusion Criteria:
1. Prior treatment with a CD37-targeting agent.
2. Prior allogeneic Hematopoietic Stem Cell Transplantation (HSCT).
3. Autologous HSCT within 3 months before the first dose of GEN3009.
4. Treatment with an anti-cancer biologic including anti-CD20 therapy, radio-conjugated
or toxin-conjugated antibody or chimeric antigen receptor (CAR) T-cell therapy within
4 weeks or 5 half-lives, whichever is shorter, before the first dose of GEN3009.
5. Chemotherapy or radiation therapy within 2 weeks of the first dose of GEN3009.
6. Treatment with an investigational drug or an invasive investigational medical device
within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of
GEN3009.
7. Autoimmune disease or other diseases that require permanent or high-dose
immunosuppressive therapy.
8. Received a cumulative dose of corticosteroids more than the equivalent of 250 mg of
prednisone within the 2-week period before the first dose of GEN3009.
9. Has uncontrolled intercurrent illness.
10. Toxicities from previous anti-cancer therapies have not resolved to baseline levels or
to Grade 1 or less except for alopecia and peripheral neuropathy.
11. Primary central nervous system (CNS) lymphoma or known CNS involvement at screening.
12. Known past or current malignancy other than inclusion diagnosis,
13. Has had major surgery within 3 weeks before screening or will not have fully recovered
from surgery, or has major surgery planned during the time the subject is expected to
participate in the trial (or within 4 weeks after the last dose of GEN3009).
14. Known history/positive serology for hepatitis B.
15. Known medical history or ongoing hepatitis C infection that has not been cured.
16. HIV tested positive at screening.
17. Is a woman who is pregnant or breast-feeding, or who is planning to become pregnant
while enrolled in this trial or within 12 months after the last dose of GEN3009.
18. Is a man who plans to father a child while enrolled in this trial or within 12 months
after the last dose of GEN3009.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Maximum Tolerated Dose |
Time Frame: | DLTs are assessed during the first treatment cycle (28 days) in each cohort. |
Safety Issue: | |
Description: | Dose liming toxicity (DLT) will be monitored to determine the maximum tolerated dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) of GEN3009. |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Genmab |
Last Updated
June 29, 2021