A Phase I/II Study With BM7PE Immunotoxin in Colorectal Cancer Patients
A legfontosabb adatok
- Ki végzi
- Oslo University Hospital
- Hol
- Norvégia1 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Leállítva
- Fázis
- 1/2. fázis
- Résztvevők
- 14 fő vett részt
- Kezdés
- 2020. aug. 31.
- Befejezés
- 2025. máj. 6.
- A vizsgálat típusa
- Beavatkozással járó, 6 csoport
- A vizsgált kezelések
- BM7PE
- A regiszteradat frissítve
- 2026. május 13.
- Miért állt le
- After interim-analysis: No signals of clinical or immunological efficacy detected, and decision was made not to continue the trial.
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 15 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- History of prior metastatic disease the last 3 years
- Chemotherapy/radiation therapy or major surgery within the last 4 weeks before start of treatment
- Alcohol or drug abuse
- 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
- 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)
- Any reason why, in the opinion of the investigator, the patient should not participate
- 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
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
This phase 1/2 study will evaluate the safety, tolerance and dose of BM7PE treating patients with colorectal cancer who have progressed to standard cell therapy or cannot tolerate such therapy. The study starts as a phase 1 study with the aim of assessing the final recommended dose of BM7PE for this group of patients. Based on the results, the study will continue into a phase 2. The phase 2 study aim to examine overall survival ≥ 9.3 months.
A vizsgálat 6 csoportja
- BM7PE Dose level 1 (2.5 µg/kg)A vizsgált kezelés
Dose level 1: BM7PE immunotoxin (2.5 µg/kg) was supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml and administered as a 20-minute i.v. infusion. The treatment was repeated after 2 weeks (day 15). The patients were treated as in-patients to stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease - at least an in-hospital stay minimum of 3 days. A 4 week follow-up for adverse events after last dose of BM7PE was performed.
Kezelés: BM7PE
- BM7PE Dose level 2 (5 µg/kg)A vizsgált kezelés
Dose level 2: BM7PE immunotoxin (5 µg/kg) was supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml and administered as a 20-minute i.v. infusion. The treatment was repeated after 2 weeks (day 15). The patients were treated as in-patients to stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease - at least an in-hospital stay minimum of 3 days. A 4 week follow-up for adverse events after last dose of BM7PE was performed.
Kezelés: BM7PE
- BM7PE Dose Level 3 (7.5 µg/kg)A vizsgált kezelés
Dose level 3: BM7PE immunotoxin (7.5 µg/kg) was supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml and administered as a 20-minute i.v. infusion. The treatment was repeated after 2 weeks (day 15). The patients were treated as in-patients to stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease - at least an in-hospital stay minimum of 3 days. A 4 week follow-up for adverse events after last dose of BM7PE was performed.
Kezelés: BM7PE
- BM7PE Dose level 4 (10 µg/kg)A vizsgált kezelés
Dose level 4: BM7PE immunotoxin (10 µg/kg) was supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml and administered as a 20-minute i.v. infusion. The treatment was repeated after 2 weeks (day 15). The patients were treated as in-patients to stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease - at least an in-hospital stay minimum of 3 days. A 4 week follow-up for adverse events after last dose of BM7PE was performed.
Kezelés: BM7PE
- BM7PE Dose level 5 (15 µg/kg)A vizsgált kezelés
Dose level 5: BM7PE immunotoxin (15 µg/kg) was supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml and administered as a 20-minute i.v. infusion. The treatment was repeated after 2 weeks (day 15). The patients were treated as in-patients to stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease - at least an in-hospital stay minimum of 3 days. A 4 week follow-up for adverse events after last dose of BM7PE was performed.
Kezelés: BM7PE
- BM7PE Dose level 6 (20 µg/kg)A vizsgált kezelés
Dose level 6: BM7PE immunotoxin (20 µg/kg) was supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml and administered as a 20-minute i.v. infusion. The treatment was repeated after 2 weeks (day 15). The patients were treated as in-patients to stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease - at least an in-hospital stay minimum of 3 days. A 4 week follow-up for adverse events after last dose of BM7PE was performed.
Kezelés: BM7PE
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- A Phase 1/2 Study With BM7PE Immunotoxin in Colorectal Cancer Patients With Metastatic Disease Who Are Refractory to or With Intolerance to Last Line of Standard Chemotherapy.
- A regiszteradat frissítve
- 2026. május 13.