GEN3014 (HexaBody®-CD38) for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Multiple Myeloma+2 MoreGEN3014 (HexaBody®-CD38) - Biological
Eligibility
18+
All Sexes
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Study Summary

This trial is a safety trial of GEN3014, a new drug. The trial has two parts: a dose escalation part, which is the first time the drug will be used in humans, and an expansion part.

Eligible Conditions
  • Multiple Myeloma
  • Non-Hodgkin's Lymphoma
  • Acute Myeloid Leukemia

Treatment Effectiveness

Study Objectives

7 Primary · 24 Secondary · Reporting Duration: From first dose until end of Cycle 2, (each cycle is 28 days)

Day 30
Escalation: Evaluate immunogenicity of GEN3014
Day 30
Escalation: Adverse events
Day 30
Escalation: To establish the PK profile of GEN3014
Escalation: To establish the pharmacokinetic profile (PK) profile of GEN3014
Day 21
Escalation: Dose limiting toxicities (DLTs)
Year 5
Dose escalation, Expansion A & B: Time-to-response (TTR)
Year 5
Dose escalation, Expansion A & B: Progression-free survival (PFS)
From first dose until end of Cycle 2
Dose escalation, Expansion A: Evaluate pharmacodynamic profiles of GEN3014
Day 28
Dose escalation, Expansion A & B: Anti-drug (GEN3014) antibody response (ADA)
Dose escalation, Expansion A & B: Pre-dose (trough) concentrations (Cthrough)
Dose escalation, Expansion A: Accumulation ratios in AUC (RA, AUC)
Dose escalation, Expansion A: Accumulation ratios in Cmax (RA, Cmax)
Dose escalation, Expansion A: Area-under-the-concentration-time curve from zero to last quantifiable sample (AUC0-last)
Dose escalation, Expansion A: Maximum (peak) plasma concentration (Cmax)
Dose escalation, Expansion A: Time to reach Cmax (Tmax)
Dose escalation, Expansion Part A: AUC from zero to 168 h (AUC0-168 h)
Expansion A: Accumulation ratios in Cthrough (RA,Cthrough)
Year 5
Dose escalation, Expansion A & B: Duration of Response (DOR)
Year 5
Expansion B: Time to next therapy (TTNT)
Day 30
Dose escalation: Number of participants with Grade 3 or 4 laboratory results
Expansion A & B: Number of participants with Grade 3 or 4 laboratory results
Expansion Part A & B: Incidence and severity of Adverse Events and Treatment Emergent Adverse Events
Day 30
Dose escalation: Incidence and severity of Adverse Events (AEs)
Year 5
Dose escalation, Expansion A: Clinical Benefit Rate (CBR)
Expansion B: Complete Response (CR)
Expansion B: Very Good Partial Response (VGPR), or better
Year 5
Dose escalation: Objective Response Rate (ORR)
Expansion B: Objective Response Rate (ORR)
Expansion Part A: Objective Response Rate (ORR)
Year 5
Dose escalation, Expansion A & B: Overall Survival (OS)
Day 28
Dose escalation: Number of participants with DLTs

Trial Safety

Side Effects for

KdD - Carfilzomib, Dexamethasone and Daratumumab
37%Thrombocytopenia
33%Anaemia
31%Diarrhoea
30%Hypertension
29%Upper respiratory tract infection
24%Fatigue
19%Dyspnoea
18%Nausea
18%Insomnia
17%Pyrexia
17%Cough
16%Back pain
16%Bronchitis
14%Neutropenia
13%Headache
12%Vomiting
12%Pneumonia
12%Muscle spasms
11%Oedema peripheral
9%Decreased appetite
9%Hyperglycaemia
9%Respiratory tract infection
9%Lymphopenia
9%Asthenia
9%Nasopharyngitis
8%Neuropathy peripheral
8%Arthralgia
7%Productive cough
7%Infusion related reaction
7%Constipation
7%Influenza
7%Dizziness
6%Peripheral sensory neuropathy
6%Leukopenia
6%Chills
6%Hypokalaemia
6%Pain in extremity
6%Rash
5%Urinary tract infection
5%Conjunctivitis
4%Sepsis
4%Oedema
2%Atrial fibrillation
2%Lower respiratory tract infection
2%Septic shock
2%Acute kidney injury
2%Plasma cell myeloma
2%Pulmonary embolism
2%Pulmonary oedema
1%Plasmacytoma
1%Osteonecrosis of jaw
1%Syncope
1%Sudden death
1%Blood creatinine increased
1%Pulmonary hypertension
1%Respiratory failure
1%Febrile neutropenia
1%Thrombotic thrombocytopenic purpura
1%Cardiac failure acute
1%Cardiac failure
1%Myocardial ischaemia
1%Atrial flutter
1%Cataract
1%Bacteraemia
1%Upper gastrointestinal haemorrhage
1%Hepatic function abnormal
1%Lung infection
1%Device related infection
1%Respiratory syncytial virus infection
1%Tumour lysis syndrome
1%Viral infection
1%Overdose
1%Posterior reversible encephalopathy syndrome
1%Interstitial lung disease
1%Pleural effusion
1%Pneumonitis
1%Cardiac arrest
1%Acute myocardial infarction
1%Cerebrovascular accident
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT03158688) in the KdD - Carfilzomib, Dexamethasone and Daratumumab ARM group. Side effects include: Thrombocytopenia with 37%, Anaemia with 33%, Diarrhoea with 31%, Hypertension with 30%, Upper respiratory tract infection with 29%.

Trial Design

5 Treatment Groups

Daratumumab - Expansion Part B
1 of 5
GEN3014 - Dose-escalation part
1 of 5
GEN3014 - Expansion Part B
1 of 5
GEN3014 - Expansion Part A
1 of 5
Treatment
1 of 5

Active Control

Experimental Treatment

272 Total Participants · 5 Treatment Groups

Primary Treatment: GEN3014 (HexaBody®-CD38) · No Placebo Group · Phase 1 & 2

GEN3014 - Dose-escalation part
Biological
Experimental Group · 1 Intervention: GEN3014 · Intervention Types: Biological
GEN3014 - Expansion Part B
Biological
Experimental Group · 1 Intervention: GEN3014 · Intervention Types: Biological
GEN3014 - Expansion Part A
Biological
Experimental Group · 1 Intervention: GEN3014 · Intervention Types: Biological
Treatment
Biological
Experimental Group · 1 Intervention: GEN3014 (HexaBody®-CD38) · Intervention Types: Biological
Daratumumab - Expansion Part B
Drug
ActiveComparator Group · 1 Intervention: Daratumumab · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from first dose until end of cycle 2, (each cycle is 28 days)

Who is running the clinical trial?

GenmabLead Sponsor
44 Previous Clinical Trials
8,607 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must sign an ICF before any preliminary examinations.
You must have recently obtained bone marrow samples during the Screening process.
Your ECOG PS score is 0, 1, or 2.
You are at least eighteen years of age.
You present acceptable laboratory test results.
A female participant must agree to use an effective form of birth control during the trial and for 12 months after their last GEN3014 dose.
Women of reproductive age must demonstrate a negative serum result for the hormone beta-human chorionic gonadotropin at Screening.
A female participant must not donate eggs for assisted reproduction, either during the trial period or within 12 months after taking their last dose of GEN3014.
A male who is engaging in sexual relations with a female of reproductive age must agree to employ an effective barrier contraceptive.