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BRIEF TITLE: Trial With Expansion Cohorts to Evaluate Safety of GEN1029 in Patients With Malignant Solid Tumors

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


  • Org Study ID: GCT1029-01
  • Secondary ID:
  • NCT ID: NCT03576131
  • NCT Alias:
  • Sponsor: Genmab - Industry
  • Source: Genmab

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 safety 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.

Overal Status Start Date Phase Study Type
Recruiting May 7, 2018 Phase 1/Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Dose Limiting Toxicities (DLTs)

Primary Outcome 1 - Time Frame: DLTs will be identified from the two first treatment cycles (28 days, a cycle is 14 days)

Primary Outcome 2 - Measure: Adverse events (AEs)

Primary Outcome 2 - Time Frame: Throughout and at the end of trial (up to 24 months after first treatment cycle (a treatment cycle is 14 days))

Condition:

  • Colorectal Cancer
  • Non-small Cell Lung Cancer
  • Triple Negative Breast Cancer
  • Renal Cell Carcinoma
  • Gastric Cancer
  • Pancreatic Cancer
  • Urothelial Cancer

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

- Uncontrolled hypertension defined as systolic blood pressure ≥160 mmHg and/or
diastolic blood pressure ≥100 mmHg, despite optimal medical management

- 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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Ruth Plummer, Professor

Role: Principal Investigator

Affiliation: Newcastle Hospitals NHS Foundation Trust

Overall Contact

Name: Genmab Trial Information

Phone: +45 70202728

Email: clinicaltrials@genmab.com

Locations

Facility Status Contact
Yale University
New Haven, Connecticut 06510
United States
Recruiting
UT M.D Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting
Hospital Univeritario Vall d'Hebron
Barcelona,
Spain
Recruiting
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle,
United Kingdom
Recruiting
The Royal Mardsen NHS Foundation Trust
Sutton,
United Kingdom
Recruiting