Colorectal Cancer Metastatic
Conditions
Keywords
Intolerance last line standard chemotherapy
Brief summary
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.
Interventions
DRUGBM7PE
BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.
Sponsors
Oslo University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Phase 1 study in colorectal cancer patients
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting Toxicity | Dose limiting toxicity event from time of study treatment and until 4 weeks after last dose of IMP, a maximum of 12 months | Number of participants experiencing a dose-limiting toxicity event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of the BM7PE: Overall Survival | Up to 12 months from start study treatment | The Overall Survival will be measured as number of months from start study treatment to date of death of any cause |
| Efficacy of the BM7PE: Progression-free Survival | Time (months) from date of first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months | The Progression-free Survival will be measured as number of months from start study treatment to date of disease progression (RECISTv1.1) or death of any cause |
| Radiological Response to BM7PE | From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months | Radiological Response Rate (assesed using RECIST v1.1) i.e. the number (and percentage) of participants in each of the response categories complete response (CR), partial response (PR), Stable disease (SD) and Progressive disease (PD). |
Countries
Norway
Contacts
PRINCIPAL_INVESTIGATORGeir O Hjortland, MDPhD
Oslo University Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 62.9 years |
| ECOG Performance status ECOG perfomance status 0 | 3 Participants |
| ECOG Performance status ECOG perfomance status 1 | 2 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 3 | 3 / 3 | 2 / 3 | 5 / 5 |
| other Total, other adverse events | 2 / 3 | 3 / 3 | 1 / 3 | 5 / 5 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 | 0 / 3 | 2 / 5 |
Outcome results
None listed