Malignant Solid Tumors, per protocol GCT1044-01 MedDRA version: 21.1 Level: LLT Classification code 10065147 Term: Malignant solid tumor System Organ Class: 100000004864
Conditions
Interventions
Product Name: DuoBody®-CD3x5T4
Product Code: GEN1044
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: GEN1044
CAS Number: 2376199-95-8
Current Sponsor code: GEN1044
Othe
Sponsors
Genmab A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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 170
Exclusion criteria
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. Has a marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc interval >480 milliseconds (ms) (CTCAE grade 1) using Fridericia’s QT correction formula. d. Uncontrolled hypertension defined as systolic blood pressure =160 mmHg and/or diastolic blood pressure =100 mmHg, despite optimal medical management. e. Ongoing or recent evidence of significant autoimmune disease f. Subjects with a history of grade 3 or higher irAEs that led to treatment discontinuation g. Subjects with a prior history of myositis, Guillain-Barré syndrome, or myasthenia gravis of any grade. h. History of chronic liver disease or evidence of hepatic cirrhosis. i. History of non-infectious pneumonitis that has required steroids, or currently has pneumonitis. j. 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. k. 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 5. Prophylaxis with live, attenuated vaccines within 3 weeks prior to first dose of GEN1044; or prophylaxis with the first and/or second injection of SARS-CoV-2 nucleic acid vaccine within 30 days prior to first dose of GEN1044.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Dose Escalation Part: • Determine recommended phase 2 dose (RP2D) • Establish safety profile of GEN1044 Dose Expansion Part: • Evaluate anti-tumor activity;Secondary Objective: Dose Escalation Part: • Establish PK profile • Evaluate immunogenicity of GEN1044 • Evaluate anti-tumor activity based on response assessment criteria (RECIST v1.1) Dose Expansion Part: • Evaluate anti-tumor activity based on response assessment criteria (RECIST v1.1) • Evaluate efficacy • Further describe the safety profile of GEN1044 • Further describe the PK profile • Further describe the immunogenicity of GEN1044;Primary end point(s): Dose Escalation Part: • Dose-limiting Toxicities (DLTs) • Adverse events (AEs) and safety laboratory parameters Dose Expansion Part: • Objective response rate (ORR) based on RECIST v1.1 ;Timepoint(s) of evaluation of this end point: During the trial, see protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Dose Escalation Part): • PK parameters • Anti-drug antibody (ADA) response • Anti-tumor activity Dose Expansion Part): • Anti-tumor activity • Progression free survival (PFS) • Overall survival (OS) • Adverse events (AEs) and safety laboratory parameters • PK parameters • Anti-drug antibody (ADA) response;Timepoint(s) of evaluation of this end point: During the trial, see protocol | — |
Countries
Belgium, Denmark, France, Israel, Korea, Republic of, Netherlands, Spain, United States
Contacts
Public ContactClinical Trial Information
Genmab A/S
Outcome results
None listed