Estado del programa
ReclutamientoFase
Fase 1Inmunoterapia previa permitida
SíEnsayo dirigido por el CRC
SíDrogas
BM7PEEtiquetas
MSI-H/ MMRd, MSS/ MMRpComentarios
BM7PE: An immunoconjugate containing BM7, a murine monoclonal antibody directed against the human tumor-associated antigen (TAA) mucin-1 (MUC1; MUC-1) covalently linked to the bacterial toxin Pseudomonas exotoxin A (PE), with potential antitumor activity.
| Ubicación | Situación |
|---|---|
| Noruega | |
|
Hospital Universitario de Oslo Oslo 0310 |
Reclutamiento |
Contactos
Criterios de inclusión
Criterios de inclusión:
Histologically verified adenocarcinoma of colon or rectum
Ambulatory with an ECOG performance status 0-1
At least 18 years of age
Progressive disease on or last line of standard chemotherapy or intolerance to further chemotherapy
Laboratory values as the following: ANC, Platelets, Hb, Creatinine, Bilirubin, ASAT, ALAT, Albumin levels, INR
Signed informed consent and expected cooperation of the patients for the treatment, and follow-up must be obtained and documented according to ICH GCP, and national/local regulations
Criterios de exclusión
Criterios de exclusión:
History of prior metastatic disease the last 3 years
History of CNS or bone metastases
Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia
Chemotherapy/radiation therapy or major surgery within the last 4 weeks before start of treatment
Alcohol or drug abuse
Any reason why, in the opinion of the investigator, the patient should not participate
Has a known history of Human Immunodeficiency Virus (HIV)
Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected)
Is pregnant or breastfeeding, or expecting to conceive or father children within the project duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
