Colorectal CancerPhase 1/2NCT03576131

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

A Phase 1/2 study testing GEN1029 (HexaBody®-DR5/DR5) in people with Colorectal Cancer and Non-small Cell Lung Cancer, run by Genmab at 6 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Cancer, Non-small Cell Lung Cancer, Triple Negative Breast Cancer
What is being tested?: GEN1029 (HexaBody®-DR5/DR5)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 6 sitesin 3 countries
Study dates: 30 Apr 2018to 12 Oct 2021
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

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

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

6 sites in 3 countries.

Country

City, postcode or hospital

6 sites in 3 countries

United States2 sites

UT M.D Anderson Cancer Center
Houston, Texas, 77030
Yale University
New Haven, Connecticut, 06510

Other trials in United States

Spain2 sites

Hospital Univeritario Vall d'Hebron
Barcelona
START Madrid CIOCC
Madrid

Other trials in Spain

United Kingdom2 sites

The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle
The Royal Mardsen NHS Foundation Trust
Sutton

Other trials in United Kingdom

About this study

Official title: First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1029 in Patients With Malignant Solid Tumors

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

Read the 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.

Conditions: Colorectal Cancer, Non-small Cell Lung Cancer, Triple Negative Breast Cancer, Renal Cell Carcinoma, Gastric Cancer, Pancreatic Cancer
Being tested: GEN1029 (HexaBody®-DR5/DR5)
Medical subject headings: Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Carcinoma, Renal Cell, Stomach Neoplasms, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GEN1029 (HexaBody®-DR5/DR5)Biological
GEN1029 will be administered intravenously. The dose levels will be determined by the starting dose and the escalation steps taken in the trial.

Study groups in NCT03576131
Study group	Role	What they receive
GEN1029 (HexaBody®-DR5/DR5)	Experimental	Not described Receives: Biological: GEN1029 (HexaBody®-DR5/DR5)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Dose Limiting Toxicities (DLTs)
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).
Measured: From Day 1 to 28 days after the first dose of study drug
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
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.
Measured: Day 1 through Day 565 (corresponding to maximum observed duration)
Number of Participants With >= Grade 3 Laboratory Results
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.
Measured: Day 1 through Day 565 (corresponding to maximum observed duration)

Secondary outcomes (15)

Maximum Observed Plasma Concentration (Cmax) of Hx-DR5-01 and Hx-DR5-05
The Cmax of Hx-DR5-01 and Hx-DR5-05 are reported.
Measured: Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
Area Under Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Hx-DR5-01 and Hx-DR5-05
The AUC(0-inf) of Hx-DR5-01 and Hx-DR5-05 are reported.
Measured: Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
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
The AUC(0-Clast) of Hx-DR5-01 and Hx-DR5-05 are reported.
Measured: Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
Total Clearance (CL) of Hx-DR5-01 and Hx-DR5-05
The CL of Hx-DR5-01 and Hx-DR5-05 are reported.
Measured: Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
Volume of Distribution (Vss) at Steady State of Hx-DR5-01 and Hx-DR5-05
The Vss of Hx-DR5-01 and Hx-DR5-05 are reported.
Measured: Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
Half-life Lambda-z (t1/2) of Hx-DR5-01 and Hx-DR5-05
The t1/2 of Hx-DR5-01 and Hx-DR5-05 are reported.
Measured: Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
Time to Reach Maximum Observed Concentration (Tmax) of Hx-DR5-01 and Hx-DR5-05
The Tmax of Hx-DR5-01 and Hx-DR5-05 are reported.
Measured: Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
Plasma Concentration of Hx-DR5-01 and Hx-DR5-05
The plasma concentration of Hx-DR5-01 and Hx-DR5-05 are reported.
Measured: Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
Number of Participants With Antidrug Antibodies (ADAs) Positive to GEN1029
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.
Measured: From Screening (Day -21 to -1) through Day 478 (corresponding to maximum observed duration)
Change From Baseline in Anti-tumor Activity Measured by Tumor Shrinkage
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.
Measured: From Baseline (Day 1) through 8.8 months (corresponding to maximum observed duration)
Number of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
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.
Measured: From Day 1 through 8.8 months (corresponding to maximum observed duration)
Progression-Free Survival (PFS) According to RECIST 1.1
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.
Measured: From Day 1 through 8.8 months (corresponding to maximum observed duration)
Overall Survival (OS) According to RECIST 1.1
Overall survival was defined as the number of days from date of first study drug administration to death due to any cause. If a subject was not known to have died, then OS was censored, and the censoring date was the latest date the subject was known to be alive (on or before the cut-off date). The OS was estimated using Kaplan-Meier method.
Measured: From Day 1 through 8.8 months (corresponding to maximum observed duration)
Duration of Response (DoR) According to RECIST 1.1
The radiological evaluation based on RECIST v1.1 was assessed using CT scan/PET-CT scan. The DoR was defined as duration from the first documentation of confirmed OR (CR or PR) to date of first progressive disease (PD) or death.
Measured: From Day 1 through 8.8 months (corresponding to maximum observed duration)
Time to Response (TTR) According to RECIST 1.1
TTR is defined as the number of days from first dose of study drug to the first documented confirmed CR or PR, which must be subsequently confirmed.
Measured: From Day 1 through 8.8 months (corresponding to maximum observed duration)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Apr 201812 Oct 2021

First posted3 Jul 2018
Study start30 Apr 2018
Primary completion12 Oct 2021
Study completion12 Oct 2021

Why it stopped: Sponsor decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
More trials run by GenmabThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03576131
Sponsor's protocol ID: GCT1029-01
Other IDs: 2017-001394-16, 236908, 2017
Status last verified: Jul 2023
First submitted: 8 May 2018
Last updated: 1 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer

All Colorectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1029 in Patients With Malignant Solid Tumors
ClinicalTrials.gov ID: NCT03576131
Acronym / sponsor ID: GCT1029-01
Conditions: Colorectal Cancer, Non-small Cell Lung Cancer, Triple Negative Breast Cancer, Renal Cell Carcinoma, Gastric Cancer, Pancreatic Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decision
Enrolment: 48 participants (actual)
Lead sponsor: GenmabIndustry (pharma, biotech, devices)
Study start: 30 Apr 2018 (actual)
Primary completion: 12 Oct 2021 (actual)
Study completion: 12 Oct 2021 (actual)
First posted: 3 Jul 2018 (actual)
Results: Posted 12 Dec 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
GEN1029 (HexaBody®-DR5/DR5)	Experimental	Biological: GEN1029 (HexaBody®-DR5/DR5)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (10 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GEN1029 (HexaBody®-DR5/DR5)GEN1029 will be administered intravenously. The dose levels will be determined by the starting dose and the escalation steps taken in the trial.	Biological	GEN1029 (HexaBody®-DR5/DR5)

Primary outcome

Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: From Day 1 to 28 days after the first dose of study drug
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).
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)
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.
Number of Participants With >= Grade 3 Laboratory Results
Time frame: Day 1 through Day 565 (corresponding to maximum observed duration)
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.

15 secondary outcomes

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
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
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
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
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
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
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
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
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)
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)
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)
Progression-Free Survival (PFS) According to RECIST 1.1
Time frame: From Day 1 through 8.8 months (corresponding to maximum observed duration)
Overall Survival (OS) According to RECIST 1.1
Time frame: From Day 1 through 8.8 months (corresponding to maximum observed duration)
Duration of Response (DoR) According to RECIST 1.1
Time frame: From Day 1 through 8.8 months (corresponding to maximum observed duration)
Time to Response (TTR) According to RECIST 1.1
Time frame: From Day 1 through 8.8 months (corresponding to maximum observed duration)

Results and safety

Results posted to the registry on 12 Dec 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Biweekly Regimen (GEN1029 0.1 mg/kg)	10	1
Biweekly Regimen (GEN1029 0.2 mg/kg)	7	2
Biweekly Regimen (GEN1029 0.3 mg/kg)	4	0
Biweekly Regimen (GEN1029 1.0 mg/kg)	11	0
Biweekly Regimen (GEN1029 2.0 mg/kg)	7	0
Biweekly Regimen (GEN1029 3.0 mg/kg)	7	0
Priming Regimen (GEN1029 0.1 mg/kg)	1	0
Intensified Regimen (GEN1029 1.0 mg/kg)	1	0

Primary outcome: Number of Participants With Dose Limiting Toxicities (DLTs)

Time frame: From Day 1 to 28 days after the first dose of study drug. Count of participants. Unit: Participants

Measure	Biweekly Regimen (GEN1029 0.1 mg/kg) n = 10	Biweekly Regimen (GEN1029 0.2 mg/kg) n = 6	Biweekly Regimen (GEN1029 0.3 mg/kg) n = 3	Biweekly Regimen (GEN1029 1.0 mg/kg) n = 10	Biweekly Regimen (GEN1029 2.0 mg/kg) n = 7	Biweekly Regimen (GEN1029 3.0 mg/kg) n = 5
Value	0	1	0	3	3	2

Population analysed: The Dose-Determining Set (DDS) consists of all participants from the Safety Set (received at least one dose of GEN1029 and analyzed according to the actual trial treatment received) who either received between 80% and 125% of the planned dose and completed the DLT observation period (Days 1-28), or experienced a DLT during Cycle 1.

Primary outcome: 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). Count of participants. Unit: Participants

Measure	Biweekly Regimen (GEN1029 0.1 mg/kg) n = 10	Biweekly Regimen (GEN1029 0.2 mg/kg) n = 7	Biweekly Regimen (GEN1029 0.3 mg/kg) n = 4	Biweekly Regimen (GEN1029 1.0 mg/kg) n = 11	Biweekly Regimen (GEN1029 2.0 mg/kg) n = 7	Biweekly Regimen (GEN1029 3.0 mg/kg) n = 7
Any TEAE	8	7	4	11	7	7
Any TESAE	3	3	2	9	6	4

Population analysed: The Safety Set consists of all participants who received at least one dose of GEN1029 and analyzed according to the actual trial treatment received.

Primary outcome: Number of Participants With >= Grade 3 Laboratory Results

Time frame: Day 1 through Day 565 (corresponding to maximum observed duration). Count of participants. Unit: Participants

Measure	Biweekly Regimen (GEN1029 0.1 mg/kg) n = 10	Biweekly Regimen (GEN1029 0.2 mg/kg) n = 7	Biweekly Regimen (GEN1029 0.3 mg/kg) n = 4	Biweekly Regimen (GEN1029 1.0 mg/kg) n = 11	Biweekly Regimen (GEN1029 2.0 mg/kg) n = 7	Biweekly Regimen (GEN1029 3.0 mg/kg) n = 7
Activated partial thromboplastin time prolonged	0	1	0	0	0	0
Alanine aminotransferase increased	1	1	2	3	1	2
Alkaline phosphatase increased	0	0	1	0	1	0
Amylase increased	0	1	1	0	0	0
Asparate aminotransferase increased	1	2	0	0	0	2
Bilirubin increased	0	0	0	1	0	0
Calcium decreased	0	1	0	0	0	0
Creatinine increased	1	0	0	0	0	0

Population analysed: The Safety Set consists of all participants who received at least one dose of GEN1029 and analyzed according to the actual trial treatment received.

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Biweekly Regimen (GEN1029 0.1 mg/kg)	3 of 10 (30%)	8 of 10 (80%)	3 of 10
Biweekly Regimen (GEN1029 0.2 mg/kg)	3 of 7 (42.9%)	7 of 7 (100%)	3 of 7
Biweekly Regimen (GEN1029 0.3 mg/kg)	2 of 4 (50%)	4 of 4 (100%)	1 of 4
Biweekly Regimen (GEN1029 1.0 mg/kg)	9 of 11 (81.8%)	11 of 11 (100%)	5 of 11
Biweekly Regimen (GEN1029 2.0 mg/kg)	6 of 7 (85.7%)	7 of 7 (100%)	4 of 7
Biweekly Regimen (GEN1029 3.0 mg/kg)	4 of 7 (57.1%)	7 of 7 (100%)	1 of 7
Priming Regimen (GEN1029 0.1 mg/kg)	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Intensified Regimen (GEN1029 1.0 mg/kg)	1 of 1 (100%)	1 of 1 (100%)	1 of 1

Limitations and caveats (from the sponsor): Results of the biweekly dosing regimens are based on the Clinical Study Report.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Colorectal Cancer

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ruth Plummer, Professor principal investigator

Newcastle Hospitals NHS Foundation Trust

6 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GEN1029 (HexaBody®-DR5/DR5) in people with Colorectal Cancer and Non-small Cell Lung Cancer, run by Genmab at 6 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose Limiting Toxicities (DLTs) (time frame: From Day 1 to 28 days after the first dose of study drug). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03576131.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.