A Safety study of GEN1044 in patients with malignant solid tumors.

Phase 1

• Conditions: Malignant Solid Tumors, per protocol GCT1044-01; MedDRA version: 21.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-003998-26-ES
• Lead Sponsor: Genmab A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-28
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 378

Inclusion Criteria

1. 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.
2. Must be =18 years of age.
3. Subject 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.
4. Must have measurable disease according to response assessment criteria relevant to the tumor type
5. Must have an Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-1 at Screening and on C1D1.
6. Must have acceptable laboratory parameters
7. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 230
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 148

Exclusion Criteria

1. Has an uncontrolled intercurrent illness, including but not limited to:
a. Ongoing or active infection requiring intravenous treatment with anti-infective therapy
b. Symptomatic congestive heart failure (grade III or IV as classified by the New York Heart Association), unstable angina pectoris or cardiac arrhythmia.
c. Uncontrolled hypertension defined as systolic blood pressure =160 mmHg and/or diastolic blood pressure =100 mmHg, despite optimal medical management.
d. Ongoing or recent evidence of significant autoimmune disease
e. Subjects with a history of grade 3 or higher irAEs that led to treatment discontinuation
f. Subjects with a prior history of myositis, Guillain-Barré syndrome, or myasthenia gravis of any grade.
g. History of chronic liver disease or evidence of hepatic cirrhosis.
h. History of non-infectious pneumonitis that has required steroids, or currently has pneumonitis.
i. 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.
j. 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:
a. 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified