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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04824794




Registration number
NCT04824794
Ethics application status
Date submitted
9/03/2021
Date registered
1/04/2021

Titles & IDs
Public title
GEN3014 Safety Trial in Relapsed or Refractory Hematologic Malignancies
Scientific title
An Open-Label, Multicenter, Phase 1/2 Trial of GEN3014 (HexaBody®-CD38) in Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies
Secondary ID [1] 0 0
2020-003781-40
Secondary ID [2] 0 0
GCT3014-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed or Refractory Multiple Myeloma (RRMM) 0 0
Diffuse Large B Cell Lymphoma (DLBCL) 0 0
Acute Myeloid Leukemia (AML) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
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
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - GEN3014
Treatment: Drugs - Daratumumab

Experimental: GEN3014 - Experimental: GEN3014 Participants in Dose Escalation phase with

* Relapsed or refractory myeloid myeloma (RRMM)
* R/R acute myeloid leukemia (AML)

Participants in Expansion Part A with

* RRMM (anti-CD38 mAb-naïve)
* RRMM (anti-CD38 mAb-refractory)
* R/R diffuse large B-cell lymphoma (DLBCL)
* R/R AML

Participants in Expansion Part B with

• RRMM (anti-CD38 mAb-naïve)

Active comparator: Daratumumab - Participants in Expansion Part B with

- RRMM (anti-CD38 mAb-naïve)


Treatment: Other: GEN3014
GEN3014 is administered by IV infusion.

Treatment: Drugs: Daratumumab
Daratumumab is administered by SC injections.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose Escalation: Number of Participants with Dose Limiting Toxicities (DLTs)
Timepoint [1] 0 0
Up to 28 days during the first cycle
Primary outcome [2] 0 0
Dose Escalation: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [2] 0 0
From first dose until the end of the safety follow-up period (30 days after last dose)
Primary outcome [3] 0 0
Expansion Part A: Objective Response Rate (ORR) of GEN3014
Timepoint [3] 0 0
Up to 8 years
Primary outcome [4] 0 0
Expansion Part B: Objective Response Rate (ORR) of GEN3014 IV vs Daratumumab SC in Anti-CD38 mAb-naive RRMM Participants
Timepoint [4] 0 0
Up to 8 years
Secondary outcome [1] 0 0
Dose Escalation: Maximum (peak) Plasma Concentration (Cmax) of GEN3014
Timepoint [1] 0 0
Predose and postdose at multiple timepoints up to Cycle 6 (Cycle length=28 days); Pre-dose and 5 minutes post end of infusion from Cycle 7 and beyond (Up to 8 years)
Secondary outcome [2] 0 0
Dose Escalation: Time to Reach Cmax (Tmax) of GEN3014
Timepoint [2] 0 0
Predose and postdose at multiple timepoints up to Cycle 6 (Cycle length=28 days); Pre-dose and 5 minutes post end of infusion from Cycle 7 and beyond (Up to 8 years)
Secondary outcome [3] 0 0
Dose Escalation: Pre-dose (trough) Concentrations (Ctrough) of GEN3014
Timepoint [3] 0 0
Predose and postdose at multiple timepoints of each Cycle (Cycle length=28 days)
Secondary outcome [4] 0 0
Dose Escalation: Area Under the Concentration Time Curve From Zero to Last Quantifiable Sample (AUC0-last)
Timepoint [4] 0 0
Predose and postdose at multiple timepoints up to Cycle 6 (Cycle length=28 days); Pre-dose and 5 minutes post end of infusion from Cycle 7 and beyond (Up to 8 years)
Secondary outcome [5] 0 0
Dose Escalation: Area Under the Concentration Time Curve From Zero to 168 hours (AUC0-168 h)
Timepoint [5] 0 0
Predose and postdose at multiple timepoints up to Cycle 6 (Cycle length=28 days); Pre-dose and 5 minutes post end of infusion from Cycle 7 and beyond (Up to 8 years)
Secondary outcome [6] 0 0
Dose Escalation: Accumulation Ratio in Cmax (RA, Cmax)
Timepoint [6] 0 0
Predose and postdose at multiple timepoints up to Cycle 6 (Cycle length=28 days); Pre-dose and 5 minutes post end of infusion from Cycle 7 and beyond (Up to 8 years)
Secondary outcome [7] 0 0
Dose Escalation: Accumulation Ratio in AUC (RA, AUC)
Timepoint [7] 0 0
Predose and postdose at multiple timepoints up to Cycle 6 (Cycle length=28 days); Pre-dose and 5 minutes post end of infusion from Cycle 7 and beyond (Up to 8 years)
Secondary outcome [8] 0 0
Dose Escalation: Number of Participants with Anti-Drug Antibody (ADA) of GEN3014
Timepoint [8] 0 0
From first dose until treatment discontinuation (Up to 8 years)
Secondary outcome [9] 0 0
Dose Escalation: Objective Response Rate (ORR) of GEN3014
Timepoint [9] 0 0
Up to 8 years
Secondary outcome [10] 0 0
Dose Escalation: Clinical Benefit Rate (CBR) of GEN3014
Timepoint [10] 0 0
Up to 8 years
Secondary outcome [11] 0 0
Dose Escalation: Duration of Response (DOR) of GEN3014
Timepoint [11] 0 0
Up to 8 years
Secondary outcome [12] 0 0
Dose Escalation: Time-to-response (TTR) of GEN3014
Timepoint [12] 0 0
Up to 8 years
Secondary outcome [13] 0 0
Dose Escalation: Progression-free survival (PFS) of GEN3014
Timepoint [13] 0 0
Up to 8 years
Secondary outcome [14] 0 0
Dose Escalation: Overall Survival (OS) of GEN3014
Timepoint [14] 0 0
Up to 8 years
Secondary outcome [15] 0 0
Expansion Part A: Clinical Benefit Rate (CBR) of GEN3014
Timepoint [15] 0 0
Up to 8 years
Secondary outcome [16] 0 0
Expansion Part A: Duration of Response (DOR) of GEN3014
Timepoint [16] 0 0
Up to 8 years
Secondary outcome [17] 0 0
Expansion Part A: Time-to-response (TTR) of GEN3014
Timepoint [17] 0 0
Up to 8 years
Secondary outcome [18] 0 0
Expansion Part A: Progression-free survival (PFS) of GEN3014
Timepoint [18] 0 0
Up to 8 years
Secondary outcome [19] 0 0
Expansion Part A: Overall Survival (OS) of GEN3014
Timepoint [19] 0 0
Up to 8 years
Secondary outcome [20] 0 0
Expansion Part A: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) per CTCAE Version 5.0
Timepoint [20] 0 0
From first dose until the end of the safety follow-up period (30 days after last dose)
Secondary outcome [21] 0 0
Expansion Part A: Number of Participants with Anti-Drug Antibody (ADA) of GEN3014
Timepoint [21] 0 0
From first dose until treatment discontinuation (Up to 8 years)
Secondary outcome [22] 0 0
Expansion Part A: Maximum (peak) Plasma Concentration (Cmax) of GEN3014
Timepoint [22] 0 0
Predose and postdose at multiple timepoints up to Cycle 6 (Cycle length=28 days); Pre-dose and 5 minutes post end of infusion from Cycle 7 and beyond (Up to 8 years)
Secondary outcome [23] 0 0
Expansion Part A: Time to Reach Cmax (Tmax) of GEN3014
Timepoint [23] 0 0
Predose and postdose at multiple timepoints up to Cycle 6 (Cycle length=28 days); Pre-dose and 5 minutes post end of infusion from Cycle 7 and beyond (Up to 8 years)
Secondary outcome [24] 0 0
Expansion Part A: Pre-dose (trough) Concentrations (Ctrough) of GEN3014
Timepoint [24] 0 0
Predose and postdose at multiple timepoints of each Cycle (Cycle length=28 days)
Secondary outcome [25] 0 0
Expansion Part A: Area Under the Concentration Time Curve From Zero to Last Quantifiable Sample (AUC0-last)
Timepoint [25] 0 0
Predose and postdose at multiple timepoints up to Cycle 6 (Cycle length=28 days); Pre-dose and 5 minutes post end of infusion from Cycle 7 and beyond (Up to 8 years)
Secondary outcome [26] 0 0
Expansion Part A: Area Under the Concentration Time Curve From Zero to 168 hours (AUC0-168 h)
Timepoint [26] 0 0
Predose and postdose at multiple timepoints up to Cycle 6 (Cycle length=28 days); Pre-dose and 5 minutes post end of infusion from Cycle 7 and beyond (Up to 8 years)
Secondary outcome [27] 0 0
Expansion Part A: Accumulation Ratio in Cmax (RA, Cmax)
Timepoint [27] 0 0
Predose and postdose at multiple timepoints up to Cycle 6 (Cycle length=28 days); Pre-dose and 5 minutes post end of infusion from Cycle 7 and beyond (Up to 8 years)
Secondary outcome [28] 0 0
Expansion Part A: Accumulation Ratio in AUC (RA, AUC)
Timepoint [28] 0 0
Predose and postdose at multiple timepoints up to Cycle 6 (Cycle length=28 days); Pre-dose and 5 minutes post end of infusion from Cycle 7 and beyond (Up to 8 years)
Secondary outcome [29] 0 0
Expansion Part A: Accumulation Ratio in Ctrough (RA,Ctrough)
Timepoint [29] 0 0
Predose and postdose at multiple timepoints up to Cycle 6 (Cycle length=28 days); Pre-dose and 5 minutes post end of infusion from Cycle 7 and beyond (Up to 8 years)
Secondary outcome [30] 0 0
Expansion Part B: Ctrough Levels of GEN3014 IV or Daratumumab SC on Cycle 3 Day 1
Timepoint [30] 0 0
Cycle 3 Day 1
Secondary outcome [31] 0 0
Expansion Part B: Very Good Partial Response (VGPR), or better of GEN3014 IV vs Daratumumab SC
Timepoint [31] 0 0
Up to 8 years
Secondary outcome [32] 0 0
Expansion Part B: Complete Response (CR) or better of GEN3014 IV vs Daratumumab SC
Timepoint [32] 0 0
Up to 8 years
Secondary outcome [33] 0 0
Expansion Part B: Duration of Response (DOR) of GEN3014 IV vs Daratumumab SC
Timepoint [33] 0 0
Up to 8 years
Secondary outcome [34] 0 0
Expansion Part B: Time-to-response (TTR) of GEN3014 IV vs Daratumumab SC
Timepoint [34] 0 0
Up to 8 years
Secondary outcome [35] 0 0
Expansion Part B: Progression-free Survival (PFS) of GEN3014 IV vs Daratumumab SC
Timepoint [35] 0 0
Up to 8 years
Secondary outcome [36] 0 0
Expansion Part B: Overall Survival (OS) of GEN3014 IV vs Daratumumab SC
Timepoint [36] 0 0
Up to 8 years
Secondary outcome [37] 0 0
Expansion Part B: Time to Next Therapy (TTNT)
Timepoint [37] 0 0
Up to 8 years
Secondary outcome [38] 0 0
Expansion Part B: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) per CTCAE Version 5.0
Timepoint [38] 0 0
From first dose until the end of the safety follow-up period (30 days after last dose)
Secondary outcome [39] 0 0
Expansion Part B: Number of Participants with Anti-Drug Antibody (ADA) of GEN3014, Anti-daratumumab Antibodies and Anti-recombinant Human Hyaluronidase PH20 (rHuPH20)
Timepoint [39] 0 0
From first dose until treatment discontinuation (Up to 8 years)

Eligibility
Key inclusion criteria
Key Inclusion Criteria

* Must have fresh bone marrow samples collected at Screening for RRMM, R/R AML, and R/R DLBCL with suspected bone marrow involvement.
* Dose Escalation phase, Expansion Part A (for MM and AML) and Expansion Part B- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0, 1, or 2. Expansion Part A (for DLBCL): ECOG PS 0 or 1.
* Has acceptable laboratory test results during the Screening period.
* A woman of reproductive potential must agree to use adequate contraception during the trial and for 12 months after the last GEN3014 or daratumumab SC administration.
* A woman of childbearing potential must have a negative serum beta-human chorionic gonadotropin (ß-hCG) at Screening and additionally, for Expansion Part B, within 72 hours of the first dose of study treatment prior to dosing.
* A woman must agree not to donate eggs (ova, oocytes) for assisted reproduction during the trial and for 12 months after receiving the last dose of GEN3014 or daratumumab SC.
* 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 and all men must not donate sperm during the trial and for 12 months after receiving the last dose of GEN3014 or daratumumab SC.

Specific for RRMM:

* Must have documented multiple myeloma as defined by the criteria below and have evidence of disease progression on the most recent prior treatment regimen based on IMWG criteria:

* Prior documentation of monoclonal plasma cells in the bone marrow =10% or presence of a biopsy-proven plasmacytoma and,
* Measurable disease at baseline as defined by any of the following:

* Immunoglobulin (Ig) G, IgA, IgD, or IgM myeloma: Serum M-protein level =0.5 g/dL (=5 g/L) or urine M protein level =200 mg/24 hours or,
* Light chain myeloma: Serum Ig free light chain (FLC) =10 mg/dL and abnormal serum Ig kappa lambda FLC ratio.

Note: Participants with RRMM must have exhausted standard therapies, at the investigator's discretion.

* For anti-CD38 mAb-naive RRMM Cohort: Participant received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory imide drug (IMiD) in any order, or is double refractory to a PI and an IMiD; or participant received = 2 prior lines of therapy if 1 of those lines included a combination of PI and IMiD. Note: Participants should not have received any anti-CD38 antibody.
* Anti-CD38 mAb-naive RRMM participants will be enrolled from ex-US countries.
* Dose Escalation phase - For anti-CD38 mAb-treated RRMM Cohort: Participant has received at least 2 prior lines of therapy and must have discontinued daratumumab or isatuximab for at least 4 weeks prior to the first dose of GEN3014. Note: Participants should not have received any other anti-CD38 antibody except daratumumab or isatuximab.

Specific for R/R AML:

* Relapsed or refractory AML, both de novo or secondary; must have failed all conventional therapy. Acute promyelocytic leukemia (APL) is excluded from this trial. Note: Relapse is defined by BM blasts =5% in patients who have been in CR previously, or reappearance of blasts in the blood, or development of extramedullary AML. Refractory is defined as not being able to achieve a CR after the initial therapy.
* Participant with relapsed AML who received at least 2 prior therapies for AML with the exception of hydroxyurea.
* Participant with refractory AML who received at least 1 prior line of therapy for AML with the exception of hydroxyurea.
* Participant's life expectancy at Screening is judged to be at least 3 months.

Specific for DLBCL:

* Expansion phase: Relapsed or refractory DLBCL, both de novo or histologically transformed. Participants with R/R DLBCL must have exhausted standard therapies, at the investigator's discretion.
* Expansion phase: Received at least 2 prior lines of systemic therapy, with 1 being a CD20-containing chemoimmunotherapy.
* Expansion phase: Have at least 1 measurable site of disease as per Lugano criteria.
* Expansion phase: Must have available archival or fresh tumor tissue or both to submit to a central laboratory for CD38 assay.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Prior treatment with any CD38-directed therapies (eg, daratumumab, isatuximab, CD38 chimeric antigen receptor T cell (CAR-T), bispecific antibody (Ab)) in anti-CD38 mAb-naive RRMM Cohort. Note: Prior daratumumab or isatuximab exposure is allowed for anti-CD38 mAb-treated RRMM participants in the Dose Escalation and anti-CD38 mAb-refractory RRMM Cohort in the Expansion Part A.
* Treatment with an anti-cancer agent, chemotherapy, radiation therapy, or major surgery within 2 weeks prior to the first dose of study treatment (Dose Escalation and Expansion Part A) or randomization (Expansion Part B).
* Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of study treatment (Dose Escalation and Expansion Part A) or randomization (Expansion Part B).
* Cumulative dose of corticosteroids more than the equivalent of =140 mg of prednisone within 2-week period before the first dose of study treatment (Dose Escalation and Expansion Part A) or maximum cumulative dose of dexamethasone 160 mg within 28 days of randomization (Expansion Part B).
* Has clinically significant cardiac disease.
* Toxicities from previous anti-cancer therapies have not resolved to baseline levels or to Grade 1 or less except for alopecia and peripheral neuropathy.
* Primary central nervous system (CNS) tumor or known CNS involvement at Screening.
* Has known history/positive serology for hepatitis B.
* Known medical history or ongoing hepatitis C infection that has not been cured.
* Known history of seropositivity of human immunodeficiency virus (HIV) (Dose Escalation and Expansion Part A) or to be positive for HIV with details in the protocol (Expansion Part B).
* Currently receiving any other investigational agents.
* 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 study treatment.
* A man who plans to father a child while enrolled in this trial or within 12 months after the last dose of study treatment.

Specific Exclusion Criteria for RRMM:

* Prior allogeneic hematopoietic stem cell transplant (HSCT).
* Autologous HSCT within 3 months of the first dose of GEN3014.

Specific Exclusion Criteria for R/R AML:

* <5% blasts in blood or bone marrow at Screening.
* White blood cell (WBC) counts =50,000/microliter (µL) in peripheral blood that cannot be controlled by hydroxyurea prior to the first dose of GEN3014.
* Prior autologous HSCT.
* Allogenic HSCT within 3 months of the first dose of GEN3014.
* Active graft-versus-host-disease requiring immunosuppressive treatment. Any immunosuppressive medication (eg, calcineurin inhibitors) must be stopped =4 weeks prior to the first dose of GEN3014.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
9/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
252
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Northern Health - Epping
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [3] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Epping
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
United States of America
State/province [2] 0 0
Ohio
Country [3] 0 0
United States of America
State/province [3] 0 0
Wisconsin
Country [4] 0 0
Bosnia and Herzegovina
State/province [4] 0 0
Banja Luka
Country [5] 0 0
Bosnia and Herzegovina
State/province [5] 0 0
Sarajevo
Country [6] 0 0
Bosnia and Herzegovina
State/province [6] 0 0
Tuzla
Country [7] 0 0
Czechia
State/province [7] 0 0
Brno
Country [8] 0 0
Czechia
State/province [8] 0 0
Nové Mesto
Country [9] 0 0
Czechia
State/province [9] 0 0
Nový Hradec Králové
Country [10] 0 0
Czechia
State/province [10] 0 0
Olomouc
Country [11] 0 0
Czechia
State/province [11] 0 0
Poruba
Country [12] 0 0
Denmark
State/province [12] 0 0
Aalborg
Country [13] 0 0
Denmark
State/province [13] 0 0
Vejle
Country [14] 0 0
France
State/province [14] 0 0
Lille
Country [15] 0 0
France
State/province [15] 0 0
Nantes
Country [16] 0 0
Georgia
State/province [16] 0 0
Tbilisi
Country [17] 0 0
Greece
State/province [17] 0 0
Athens
Country [18] 0 0
Greece
State/province [18] 0 0
Río
Country [19] 0 0
Greece
State/province [19] 0 0
Thessaloníki
Country [20] 0 0
Hungary
State/province [20] 0 0
Nyíregyháza
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Gwangju
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Pusan
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Seongnam
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Seoul
Country [25] 0 0
Malaysia
State/province [25] 0 0
Ampang
Country [26] 0 0
Malaysia
State/province [26] 0 0
Johor Bahru
Country [27] 0 0
Malaysia
State/province [27] 0 0
Kuching
Country [28] 0 0
Malaysia
State/province [28] 0 0
Petaling Jaya
Country [29] 0 0
Moldova, Republic of
State/province [29] 0 0
Chisinau
Country [30] 0 0
Netherlands
State/province [30] 0 0
Maastricht
Country [31] 0 0
Netherlands
State/province [31] 0 0
Rotterdam
Country [32] 0 0
Netherlands
State/province [32] 0 0
Utrecht
Country [33] 0 0
New Zealand
State/province [33] 0 0
Auckland
Country [34] 0 0
New Zealand
State/province [34] 0 0
Christchurch
Country [35] 0 0
New Zealand
State/province [35] 0 0
Grafton
Country [36] 0 0
New Zealand
State/province [36] 0 0
Palmerston North
Country [37] 0 0
North Macedonia
State/province [37] 0 0
Skopje
Country [38] 0 0
Philippines
State/province [38] 0 0
Makati City
Country [39] 0 0
Poland
State/province [39] 0 0
Gdansk
Country [40] 0 0
Poland
State/province [40] 0 0
Katowice
Country [41] 0 0
Poland
State/province [41] 0 0
Kraków
Country [42] 0 0
Poland
State/province [42] 0 0
Wroclaw
Country [43] 0 0
Spain
State/province [43] 0 0
Pamplona
Country [44] 0 0
Spain
State/province [44] 0 0
Salamanca
Country [45] 0 0
Sweden
State/province [45] 0 0
Huddinge
Country [46] 0 0
Sweden
State/province [46] 0 0
Lund
Country [47] 0 0
Ukraine
State/province [47] 0 0
Kyiv

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
+45 70202728
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04824794