NCT03576131 · REGISTRY CONDITION SEARCH

GEN1029 (HexaBody®-DR5/DR5) Safety Trial in Patients With Malignant Solid Tumors

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1, PHASE2
Status at capture: TERMINATED
Registry last update: 2023-08-01

The purpose of the trial is to evaluate the safety of GEN1029 (HexaBody®-DR5/DR5) in a mixed population of patients with specified solid tumors

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Dose Limiting Toxicities (DLTs)

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outcome · POSTED

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

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outcome · POSTED

Number of Participants With >= Grade 3 Laboratory Results

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outcome · POSTED

Maximum Observed Plasma Concentration (Cmax) of Hx-DR5-01 and Hx-DR5-05

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outcome · POSTED

Area Under Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Hx-DR5-01 and Hx-DR5-05

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outcome · POSTED

Area Under Plasma Concentration-time Curve From Time Zero to the Time of Last Nonzero Concentration (AUC[0-Clast]) of Hx-DR5-01 and Hx-DR5-05

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outcome · POSTED

Total Clearance (CL) of Hx-DR5-01 and Hx-DR5-05

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outcome · POSTED

Volume of Distribution (Vss) at Steady State of Hx-DR5-01 and Hx-DR5-05

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outcome · POSTED

Half-life Lambda-z (t1/2) of Hx-DR5-01 and Hx-DR5-05

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outcome · POSTED

Time to Reach Maximum Observed Concentration (Tmax) of Hx-DR5-01 and Hx-DR5-05

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outcome · POSTED

Plasma Concentration of Hx-DR5-01 and Hx-DR5-05

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outcome · POSTED

Number of Participants With Antidrug Antibodies (ADAs) Positive to GEN1029

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outcome · POSTED

Change From Baseline in Anti-tumor Activity Measured by Tumor Shrinkage

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outcome · POSTED

Number of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

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outcome · POSTED

Progression-Free Survival (PFS) According to RECIST 1.1

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outcome · POSTED

Overall Survival (OS) According to RECIST 1.1

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outcome · POSTED

Duration of Response (DoR) According to RECIST 1.1

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outcome · POSTED

Time to Response (TTR) According to RECIST 1.1

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria (main): * Patients with advanced and/or metastatic cancer who have no available standard therapy or who are not candidates for available standard therapy, and for whom, in the opinion of the investigator, experimental therapy with GEN1029 may be beneficial. * Patient must be ≥ 18 years of age * Patients must have measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 * Have an acceptable hematological status * Have an acceptable renal function * Have an acceptable liver function * Have an Eastern Cooperative Oncology Group performance status of 0 or 1 * Body weight ≥ 40kg * Patients both females and males, of childbearing or reproductive potential must agree to use adequate contraception from screening visit until six months after last infusion of GEN1029 Exclusion Criteria (main): * Acute deep vein thrombosis or clinically relevant pulmonary embolism, not stable for at least 8 weeks prior to first GEN1029 administration * Have clinically significant cardiac disease * Have uncontrolled hypertension as defined in the protocol * Any history of intracerebral arteriovenous malformation, cerebral aneurysm, new (younger than 6 months) or progressive brain metastases or stroke * History of organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of Investigational Medicinal Product (IMP) * Have received a cumulative dose of corticosteroid ≥ 150 mg prednisone (or equivalent doses of corticosteroids) within two weeks before the first GEN1029 administration * History of ≥ grade 3 allergic reactions to monoclonal antibody therapy as well as known or suspected allergy or intolerance to any agent given in the course of this trial * Radiotherapy within 14 days prior to first GEN1029 administration * Any prior therapy with a compound targeting DR4 or DR5 * History of chronic liver disease or evidence of hepatic cirrhosis
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Biological: GEN1029 (HexaBody®-DR5/DR5)
label
GEN1029 (HexaBody®-DR5/DR5)
type
EXPERIMENTAL

interventions

arm Group Labels
GEN1029 (HexaBody®-DR5/DR5)
description
GEN1029 will be administered intravenously. The dose levels will be determined by the starting dose and the escalation steps taken in the trial.
name
GEN1029 (HexaBody®-DR5/DR5)
type
BIOLOGICAL

Study design

allocation

intervention Model

SEQUENTIAL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 48
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
DLT criteria in the dose escalation phase of this trial are defined as hematologic toxicity including Grade (G) 4 neutropenia/thrombocytopenia for minimal duration of 7 days, G3/4 febrile neutropenia, \>=G3 thrombocytopenia with bleeding, or G4 anemia; and non-hematologic toxicity including G4 infusion-related reactions (IRR) or anaphylaxis, G3 IRR did not resolve to =\<G1 within 24 hours, \>=G3 diarrhea/vomiting (did not respond to optimal treatment within 2 days), G3 nausea (did not respond to optimal treatment within 7days), or Hy's law or protocol-specified toxicities related to liver function test results or amylase and/or lipase elevations; or any \>=G3 possibly related non-hematological AE, which occurred during first 2 cycles (as specified in protocol).
measure
Number of Participants With Dose Limiting Toxicities (DLTs)
time Frame
From Day 1 to 28 days after the first dose of study drug
description
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is defined as an AE that meets one of the following criteria: fatal or life-threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; medically significant (an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above \[medical and scientific judgment must be exercised in deciding whether an AE is 'medically important'\]); required inpatient hospitalization or prolongation of existing hospitalization. A TEAE is defined as an AE occurring or worsening during the treatment period including the safety follow-up period.
measure
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
time Frame
Day 1 through Day 565 (corresponding to maximum observed duration)
description
Number of participants with laboratory measurements of Grade \>= 3 by NCI-CTCAE v4.03 are reported. The NCI-CTCAE is a descriptive terminology is used for AE reporting. The NCI-CTCAE v4.03 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Based on this general guideline: Grade 1 as mild AE, Grade 2 as moderate AE, Grade 3 as severe AE, Grade 4 as life-threatening or disabling AE, and Grade 5 as death. In case a participant reported multiple severity grades for an AE, only the maximum grade was used.
measure
Number of Participants With >= Grade 3 Laboratory Results
time Frame
Day 1 through Day 565 (corresponding to maximum observed duration)

secondary Outcomes

description
The Cmax of Hx-DR5-01 and Hx-DR5-05 are reported.
measure
Maximum Observed Plasma Concentration (Cmax) of Hx-DR5-01 and Hx-DR5-05
time Frame
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
description
The AUC(0-inf) of Hx-DR5-01 and Hx-DR5-05 are reported.
measure
Area Under Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Hx-DR5-01 and Hx-DR5-05
time Frame
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
description
The AUC(0-Clast) of Hx-DR5-01 and Hx-DR5-05 are reported.
measure
Area Under Plasma Concentration-time Curve From Time Zero to the Time of Last Nonzero Concentration (AUC[0-Clast]) of Hx-DR5-01 and Hx-DR5-05
time Frame
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
description
The CL of Hx-DR5-01 and Hx-DR5-05 are reported.
measure
Total Clearance (CL) of Hx-DR5-01 and Hx-DR5-05
time Frame
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
description
The Vss of Hx-DR5-01 and Hx-DR5-05 are reported.
measure
Volume of Distribution (Vss) at Steady State of Hx-DR5-01 and Hx-DR5-05
time Frame
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
description
The t1/2 of Hx-DR5-01 and Hx-DR5-05 are reported.
measure
Half-life Lambda-z (t1/2) of Hx-DR5-01 and Hx-DR5-05
time Frame
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
description
The Tmax of Hx-DR5-01 and Hx-DR5-05 are reported.
measure
Time to Reach Maximum Observed Concentration (Tmax) of Hx-DR5-01 and Hx-DR5-05
time Frame
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
description
The plasma concentration of Hx-DR5-01 and Hx-DR5-05 are reported.
measure
Plasma Concentration of Hx-DR5-01 and Hx-DR5-05
time Frame
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
description
From positive ADA samples titer values and neutralizing antibody scores (positive or negative) were determined and reported. A participant was considered positive if negative at baseline (screening) and had at least one positive post-baseline result, or positive at baseline and had at least one positive post-baseline result with a titer higher than baseline. Number of participants with ADA positive to GEN1029 are reported.
measure
Number of Participants With Antidrug Antibodies (ADAs) Positive to GEN1029
time Frame
From Screening (Day -21 to -1) through Day 478 (corresponding to maximum observed duration)
description
Anti-tumor activity measured by tumor shrinkage was evaluated on based on of sum of the diameter(s) of all target lesions from the computerized tomography (CT) scan/positron emission tomography (PET)-CT scan. Largest tumor shrinkage is reported.
measure
Change From Baseline in Anti-tumor Activity Measured by Tumor Shrinkage
time Frame
From Baseline (Day 1) through 8.8 months (corresponding to maximum observed duration)
description
The radiological evaluation was based on RECIST v1.1 using CT scan/PET-CT scan. The OR was defined as complete response (CR) or partial response (PR) per RECIST v1.1. The CR was defined as disappearance of all target and non-target lesions and reduction in short axis to \<10 mm of any pathological and non-pathological lymph nodes. The PR was defined as \>=30% decrease in sum of diameters of target lesions (compared to baseline), no unequivocal progression of existing non-target lesions, and no new lesion.
measure
Number of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
time Frame
From Day 1 through 8.8 months (corresponding to maximum observed duration)
description
The PFS was defined as the number of days from the date of first study drug administration to first progressive disease (PD) or death from any cause. The PD was defined as at least 20% (and \>= 5 mm) increase in the sum of the longest diameter (LD) of target lesions, compared to the smallest sum of the target LDs recorded while in trial or the appearance of 1 or more new lesions; unequivocal progression of existing non-target lesions; and/or new lesion. The radiological evaluation based on RECIST v1.1 was assessed using CT scan/PET scan. The PFS was estimated using Kaplan-Meier method.
measure
Progression-Free Survival (PFS) According to RECIST 1.1
time Frame
From Day 1 through 8.8 months (corresponding to maximum observed duration)

Full study description

brief Summary: The purpose of the trial is to evaluate the safety of GEN1029 (HexaBody®-DR5/DR5) in a mixed population of patients with specified solid tumors
detailed Description: The trial is an open-label, multi-center first-in-human trial of GEN1029 (HexaBody®-DR5/DR5). The trial consists of two parts a dose escalation part (phase 1, first-in-human (FIH) and an expansion part (phase 2a). The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) has been determined.

Source references

Source notices and limitations

Discovery and provenance

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query cond
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Preserved source evidence · Not medical advice