First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1046 in Subjects With Malignant Solid Tumors

INTRODUCTION

  • Org Study ID: GCT1046-01
  • Secondary ID: N/A
  • NTC ID: NCT03917381
  • Sponsor: Genmab

BRIEF SUMMARY

The purpose of the trial is to evaluate the safety of GEN1046 in patients with malignant solid tumors

DETAILED DESCRIPTION

The trial is an open-label, multi-center safety trial of GEN1046. 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.

  • Overall Status
    Recruiting
  • Start Date
    May 14, 2019
  • Phase
    Phase 1, Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Dose limiting toxicity (DLT)

Primary Outcome 1 - Timeframe: DLTs are assessed during the first cycle (21 days) in each cohort]

Primary Outcome 2 - Measure: Adverse events

Primary Outcome 2 - Timeframe: AEs are collected throughout the study and up to 2 months after last subject last treatment

Primary Outcome 3 - Measure: Safety laboratory parameters (hematology, biochemistry, coagulation, endocrines)

Primary Outcome 3 - Timeframe: Safety laboratory data are collected throughout the study and up to 2 months after last subject last treatment

CONDITION

  • Solid Tumors
  • Non-small Cell Lung Cancer
  • Urothelial Carcinoma
  • Endometrial Carcinoma
  • Triple Negative Breast Cancer
  • Squamous Cell Carcinoma of the Head and Neck
  • Cervical Cancer

ELIGIBILITY

Inclusion Criteria:
For Dose Escalation:
• Have a histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is no available standard therapy
For Expansion:
• Have histologically or cytological confirmed diagnosis of relapsed or refractory, advanced and/or metastatic NSCLC, EC, UC, TNBC, SCCHN, or cervical cancer who are not anymore candidates for standard therapy
For Both Dose Escalation and Expansion
Have measurable disease according to RECIST 1.1

- Have Eastern Cooperative Oncology Group (ECOG) 0-1

- Have an acceptable hematological status

- Have acceptable liver function

- Have an acceptable coagulation status

- Have acceptable renal function
Exclusion Criteria:
Have uncontrolled intercurrent illness, including but not limited to:
Ongoing or active infection requiring intravenous treatment with antiinfective therapy

- Symptomatic congestive heart failure (Grade III or IV as classified by the New York Heart Association), unstable angina pectoris or cardiac arrhythmia

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

- Ongoing or recent evidence of autoimmune disease

- History of irAEs that led to prior checkpoint treatment discontinuation

- Prior history of myositis, Guillain-Barré syndrome, or myasthenia gravis of any grade

- History of chronic liver disease or evidence of hepatic cirrhosis

- History of non-infectious pneumonitis that has required steroids or currently has pneumonitis

- 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 GEN1046

- Serious, non-healing wound, skin ulcer (of any grade), or bone fracture

- Any history of intracerebral arteriovenous malformation, cerebral aneurysm, new (younger than 6 months) or progressive brain metastases or stroke
Prior therapy:
Radiotherapy: Radiotherapy within 14 days prior to first GEN1046 administration. Palliative radiotherapy will be allowed.

- Treatment with an anti-cancer agent (within 28 days or after at least 5 half-lives of the drug, whichever is shorter), prior to GEN1046 administration. Accepted exceptions are bisphosphonates (e.g., pamidronate, zoledronic acid, etc.) and denosumab

- Toxicities from previous anti-cancer therapies that have not adequately resolved

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: +4570202728

Email: clinicaltrials@genmab.com

LOCATION

Facility Status Contact
Facility: Mayo Clinic
Phoenix, Arizona 85054
United States
Status: Recruiting Contact: Contact
Clinical Trials Referral Office
855-776-0015
Facility: Yale University Cancer Center
New Haven, Connecticut 06520-8028
United States
Status: Recruiting Contact: Contact
Cassandra Moore, Dr.
855-776-0015
Facility: Mayo Clinic
Jacksonville, Florida 32224
United States
Status: Recruiting Contact: Contact
Patricia M LoRusso
855-776-0015
Facility: Emory University
Atlanta, Georgia 30322
United States
Status: Recruiting Contact: Contact
Clinical Trials Referral Office

Facility: University of Iowa Hospitals
Iowa City, Iowa 52242
United States
Status: Recruiting Contact: Contact
Yanyan Lou, Dr.

Facility: Norton Healthcare Inc
Louisville, Kentucky 40202
United States
Status: Recruiting Contact: Contact
Suresh Ramalingam

Facility: University of Michigan
Ann Arbor, Michigan 48109
United States
Status: Recruiting Contact: Contact
Muhammed Furqan

Facility: START Midwest
Grand Rapids, Michigan 49546
United States
Status: Recruiting Contact: Contact
John Hamm

Facility: Mayo Clinic
Rochester, Minnesota 55905
United States
Status: Recruiting Contact: Contact
Erin Cobain

Facility: Washington University School of Medicine
Saint Louis, Missouri 63110
United States
Status: Recruiting Contact: Contact
Manish Sharma

Facility: NYU Langone
New York, New York 10016
United States
Status: Recruiting Contact: Contact
Clinical Trials Referral Office

Facility: UNC Chapel Hill
Chapel Hill, North Carolina 27514
United States
Status: Recruiting Contact: Contact
Ashish Chintakuntlawar, Dr.

Facility: Levine Cancer Institute, Atrium Health
Charlotte, North Carolina 28204
United States
Status: Recruiting Contact: Contact
Jeffrey Ward

Facility: University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
Status: Recruiting Contact: Contact
Daniel Cho

Facility: University Hospital Brno
Brno, 12000
Czechia
Status: Recruiting Contact: Contact
Jared Weiss

Facility: Fakultni nemocnice Olomouc
Olomouc, 64239
Czechia
Status: Recruiting Contact: Contact
Daniel Haggstrom

Facility: Onkologiai Klinika
Debrecen, 52621
Hungary
Status: Recruiting Contact: Contact
Alberto Montero

Facility: BKMK Hospital
Kecskemét, 08035
Hungary
Status: Recruiting Contact: Contact
Zdenek Kral

Facility: Pulmonology Hospital Törökbálinti
Törökbálint, 28040
Hungary
Status: Recruiting Contact: Contact
Bohuslav Melichar

Facility: Rambam Health Care Campus RHCC - Rambam Medical Center
Haifa, 28041
Israel
Status: Recruiting Contact: Contact
Peter Arkosy

Facility: Hadassah Medical Organization HMO - Sharett Institute of Oncology
Jerusalem, 28050
Israel
Status: Recruiting Contact: Contact
Judit Kocsis

Facility: Tel Aviv Sourasky Medical Center
Tel Aviv, 31008
Israel
Status: Recruiting Contact: Contact
Gabriella Galffy

Facility: Sheba Medical Center, Ramat Gan
Tel HaShomer, 46010
Israel
Status: Recruiting Contact: Contact
Corinne Maurice-Dror

Facility: IRCCS - Istituto Europeo di Oncologia IEO
Milan,
Italy
Status: Recruiting Contact: Contact
Tamar Peretz Yablonski

Facility: Istituto Nazionale Tumori - Fondazione Pascale Italy
Napoli,
Italy
Status: Recruiting Contact: Contact
Ravit Geva

Facility: AUSL Romagno-Ravenna
Ravenna,
Italy
Status: Recruiting Contact: Contact
Eytan Ben-Ami

Facility: Policlinico Uni. Campus Bio-Medico
Roma,
Italy
Status: Recruiting Contact: Contact
Giuseppe Curigliano

Facility: Regina Elena National Cancer Institute
Rome,
Italy
Status: Recruiting Contact: Contact
Paolo Ascierto

Facility: Uniwersyteckie Centrum Kliniczne
Gdańsk,
Poland
Status: Recruiting Contact: Contact
Manolo D'Arcangelo

Facility: Dom Lekarski SA
Szczecin,
Poland
Status: Recruiting Contact: Contact
Giuseppe Tonini

Facility: Maria Sklodowska Curie National Research Instutute of Oncology
Warsaw,
Poland
Status: Recruiting Contact: Contact
Federico Cappuzzo

Facility: Medpolonia Sp. z o.o.
Wielkopolskie,
Poland
Status: Recruiting Contact: Contact
Jacek Jassem

Facility: Hospital Universitario Vall dHebron
Barcelona,
Spain
Status: Recruiting Contact: Contact
Piotr Serwatowski

Facility: START Madrid-FJD, Hospital Fundación Jiménez Díaz
Madrid,
Spain
Status: Recruiting Contact: Contact
Iwona Lugowska

Facility: Hospital Universitario 12 de Octubre
Madrid,
Spain
Status: Recruiting Contact: Contact
Rodryg Ramlau

Facility: START Madrid-CIOCC
Madrid,
Spain
Status: Recruiting Contact: Contact
Elena Garralda Cabanas

Facility: Hospital Universitario La Princesa
Madrid,
Spain
Status: Recruiting Contact: Contact
Victor Moreno

Facility: MD Anderson Cancer Center Madrid
Madrid,
Spain
Status: Recruiting Contact: Contact
Santiago Ponce

Facility: Hospital Universitario Virgen de la Victoria
Málaga,
Spain
Status: Recruiting Contact: Contact
Emiliano Calvo

Facility: Clinica Universidad de Navarra
Pamplona,
Spain
Status: Recruiting Contact: Contact
Ramon Colomer

Facility: Hospital Clinico De Valencia
Valencia,
Spain
Status: Recruiting Contact: Contact
Enrique Grande Pulido