The purpose of the trial is to evaluate the safety, determine the recommended phase 2 dose, and assess preliminary clinical activity of GEN1044 in subjects with solid tumors.
The trial is an open-label, multi-center safety trial of GEN1044. The trial consists of two
parts: a dose escalation part (phase 1) 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
from phase 1.
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||July 15, 2020||Phase 1/Phase 2||Interventional|
Primary Outcome 1 - Measure: Dose Escalation Part: Dose Limiting Toxicities (DLTs)
Primary Outcome 1 - Time Frame: DLTs will be assessed during the first cycle (21 days) in each cohort
Primary Outcome 2 - Measure: Adverse Events (AEs)
Primary Outcome 2 - Time Frame: AEs are collected throughout trial until the end of the safety follow-up period (30 days after last dose)
Primary Outcome 3 - Measure: Expansion Part: Evaluate anti-tumor activity
Primary Outcome 3 - Time Frame: Response assessment will be evaluated through trial completion, up to 5 years after last patient first visit.
Primary Outcome 4 - Measure: Safety Laboratory parameters (Hematology: Hematocrit, Hemoglobin Mean platelet volume, Platelet Count, Red Blood Cell Count, White Blood Cell Count) )
Primary Outcome 4 - Time Frame: Safety Laboratory parameters are collected throughout trial until the end of the safety follow-up period (30 days after last dose)
Primary Outcome 5 - Measure: Safety Laboratory parameters (Biochemistry: ALP, ALT, Amylase, AST, Bilirubin, BUN, Calcium, Chloride, Creatinine, CRP, Albumin, GGT, Glucose, Glycosylated hemoglobin, LDH, Lipase, Magnesium, Nitrogen, Phosphate, Potassium, Protein, Sodium, Uric acid)
Primary Outcome 5 - Time Frame: Safety Laboratory parameters are collected throughout trial until the end of the safety follow-up period (30 days after last dose)
Primary Outcome 6 - Measure: Safety Laboratory parameters (Coagulation: Prothrombin time, International normalized ratio, Activated partial thromboplastin time)
Primary Outcome 6 - Time Frame: Safety Laboratory parameters are collected throughout trial until the end of the safety follow-up period (30 days after last dose)
Primary Outcome 7 - Measure: Safety Laboratory parameters (Urinalysis: Leukocytes, Protein)
Primary Outcome 7 - Time Frame: Safety Laboratory parameters are collected throughout trial until the end of the safety follow-up period (30 days after last dose)
Key Inclusion Criteria:
Dose Escalation Part:
• Subject with locally advanced or metastatic solid tumor(s) (excluding subjects with
primary central nervous system [CNS] tumors), who has experienced disease progression while
on standard therapy or is intolerant of, or not eligible for, standard therapy.
• Must have an advanced or metastatic, pathologically confirmed diagnosis of one of the
following tumors: Uterine Cancer, Prostate Cancer, Esophageal Cancer, Triple Negative
Breast Cancer (TNBC), Squamous Cell Carcinoma of the Head and Neck (SCCHN), Non-small Cell
Lung Cancer (both adenocarcinoma (ACC) and squamous cell carcinoma (SCC) (NSCLC/ACC and
NSCLC/SCC), Bladder Cancer.
- Must sign an informed consent form (ICF) indicating that he or she understands the
purpose of, and procedures required for the trial, and is willing to participate in
the trial prior to any trial related assessments or procedures.
- Must have measurable disease according to response assessment criteria relevant to the
- Must have an Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of
0-1 at Screening and on C1D1.
- A woman of reproductive potential must agree to use adequate contraception during the
trial and for 4 months after the last GEN1044 administration. Adequate contraception
is defined as highly effective methods of contraception.
Key Exclusion Criteria (both parts):
1. Has an uncontrolled intercurrent illness, including but not limited to:
1. Ongoing or active infection requiring intravenous treatment with anti-infective
2. Symptomatic congestive heart failure (grade III or IV as classified by the New
York Heart Association), unstable angina pectoris or cardiac arrhythmia.
3. Uncontrolled hypertension defined as systolic blood pressure ≥160 mmHg and/or
diastolic blood pressure ≥100 mmHg, despite optimal medical management.
4. Ongoing or recent evidence of significant autoimmune disease Subjects with a
history of grade 3 or higher irAEs that led to treatment discontinuation.
5. Subjects with a prior history of myositis, Guillain-Barré syndrome, or myasthenia
gravis of any grade.
6. History of chronic liver disease or evidence of hepatic cirrhosis.
7. History of non-infectious pneumonitis that has required steroids, or currently
8. 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 GEN1044.
9. Serious, non-healing wound, skin ulcer (of any grade), or bone fracture.
2. Any history of intracerebral arteriovenous malformation, cerebral aneurysm, new or
symptomatic brain metastases or stroke.
3. Prior therapy:
Radiotherapy: Radiotherapy within 14 days prior to first GEN1044 administration.
Palliative radiotherapy will be allowed.
4. Treatment with an anti-cancer agent (within 28 days or after at least 5 half-lives of
the drug, whichever is shorter), prior to GEN1044 administration. Toxicities from
previous anti-cancer therapies that have not resolved.
5. Has a history of ≥ grade 2 cytokine release syndrome (CRS) with other CD3-based
bispecifics, or a history of ≥ grade 3 allergic reactions to monoclonal antibody
therapy as well as known or has known allergies, hypersensitivity, or intolerance to
GEN1044 or its excipients.
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Roberto Oliveri, MD
Role: Study Director
Name: Genmab Trial Information
|Washington University School of Medicine
Saint Louis, Missouri 63110
|Not yet recruiting||
Ramaswamy Govindan, MD
|Tennesse Oncology, PLLC - Nashville
Nashville, Tennessee 37203
Melissa Johnson, MD
|MD Anderson Cancer center
Houston, Texas 77054
|Not yet recruiting||
Aung Naing, MD
|Rigshospitalet (Copenhagen University Hospital)
Kristian Rohrberg, MD
|Chaim Sheba Medical Center
Ramat Gan, 5265601
Eytan Ben-Ami, MD
|Hospital Universitari Vall d'Hebron
Elena Garralda Cabanas, MD
|Fundacion Jimenez Diaz
Victor Moreno, MD