A study to find the best dose of BI 905711 in combination with chemotherapy and to test whether this dose helps people with advanced gastrointestinal cancers.
- Conditions
- Colorectal adenocarcinoma (CRC) and Pancreatic Ductal Adenocarcinoma (PDAC)
- Registration Number
- JPRN-jRCT2031210462
- Lead Sponsor
- Imazu Susumu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
Applicable to both Phase Ia and Phase Ib Cohorts:
1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
2. Of legal adult age (according to local legislation) at screening.
3. Histologically or cytologically confirmed, advanced unresectable or metastatic colorectal adenocarcinoma
4. CRC : Patients who have PD after prior oxaliplatin-based first line therapy or within 6 months after the end of oxaliplatin-based adjuvant therapy.
5. Eastern Cooperative Oncology Group (ECOG) performance status <= 1
6. Life expectancy >= 3 months in the opinion of the investigator
7. Availability and willingness to provide tumor tissue (fresh biopsy or archival) for biomarker analysis.
8.Adequate hepatic, pancreatic, renal and bone marrow functions as defined below:
-Total bilirubin <= 1.5 x institutional upper level of normal (ULN)
-Alanine transaminase (ALT) and Aspartate transaminase (AST) <= 2.5 x institutional ULN or <= 5 x institutional ULN for patients with known liver metastases
-Serum creatinine <=1.5x institutional ULN. If creatinine is > 1.5 x ULN, patient is eligible if concurrent creatinine clearance more than 50 ml/min (more than 0.05L/min) (measured or calculated by CKD-EPI formula or Japanese version of CKD-EPI formula for Japanese patients)
-Absolute neutrophil count (ANC) >= 1.5 x 109/L, >= 1.5 x 103/microL, or more than 1500/mm3
-Platelets >= 100 x 109/ L, >= 100 x 103/microL, or >= 100 x 103/mm3
-Hemoglobin (Hb) >= 8.5 g/dl, >= 85 g/L, or >= 5.3 mmol/L (without transfusion within previous week)
-Serum lipase <= 1.5 institutional ULN
9. Recovery, from any adverse events (AEs) of previous anti-cancer therapies, to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade 1 except for CTCAE grade 2 alopecia or peripheral sensory neuropathy, or other CtCAE grade 2 AEs considered not clinically significant in the inverstigator's opinion.
10. Male or female patients. Women of childbearing potential (WOCBP)1 and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
Additionally, criterion 11 is applicable to Phase Ia cohort only
11. Patient with either measurable or non-measurable disease.
Additionally, criterion 12-14 is applicable to Phase Ib cohorts only
12. At least one target lesion that can be accurately measured per RECIST 1.1
PDAC Patients must also meet the followings:
13. Histologically or cytologically confirmed, advanced unresectable or metastatic CDH17 positive pancreatic adenocarcinoma
14. Patients who have PD after prior platin and/or gemcitabine-based first line therapy.
Applicable to both Phase Ia and Phase Ib cohorts
1. Any prior irinotecan-based therapy in the metastatic setting.
2. Previous systemic anti-cancer therapy within the specified timeframe from the last dose intake to the first dose of trial treatment as follows:
- Any non-investigational drug, including anti-angiogenic agents (bevacizumab or ramucirumab or aflibercept) and anti-EGFR antibodies (cetuximab or panitumumab), within 14 days.
- Any investigational drug or other antibodies including immune checkpoint inhibitors, within 28 days.
3. Currently enrolled in another investigational device or drug trial. Patients who are in follow-up/observation for another clinical trial are eligible.
4. Radiation therapy within 4 weeks prior to start of treatment. However, palliative radiotherapy for symptomatic metastasis is allowed if completed within 2 weeks prior to start of treatment.
5. Any serious concomitant disease or medical condition affecting compliance with trial requirements or which are considered relevant for the evaluation of the efficacy or safety of the trial drug, such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with trial participation or trial drug administration, and in the judgment of the Investigator, would make the patient inappropriate for entry into the trial.
6. Known pathological condition of GI tract, liver and pancreas, excluding the disease under study, that may interfere with assessment of drug safety or may increase the risk of toxicity:
a. inflammatory bowel disease
b. chronic pancreatitis
c. other serious GI pathological conditions by judgment of the investigator e.g. autoimmune disease with GI involvement, unexplained active diarrhea CTCAE v5.0 grade >=2.
7.Known history of human immunodeficiency virus (HIV) infection.
8.Any of the following laboratory evidence of hepatitis virus infection. Test results obtained in routine diagnostics are acceptable if done within 14 days before the informed consent date:
- Positive results of hepatitis B surface (HBs) antigen
- Presence of HBc antibody together with HBV-DNA
- Presence of hepatitis C RNA
9. Previous or concomitant malignancies, other than the one treated in this trial within the last 2 years with the exception of the following:
- Effectively treated non-melanoma skin cancers
- Effectively treated carcinoma in situ of the cervix
- Effectively treated ductal carcinoma in situ
- Other effectively treated malignancy that is considered cured by local treatment
10. Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes the patient an unreliable trial participant or unlikely to comply with the protocol requirements or not epected to complete the trial as scheduled.
11. Women who are pregnant, nursing, or who plan to become pregnant while in the trial; female patients who do not agree to the interruption of breast feeding from the start of study treatment through 6 months after the last study treatment.
12. Presence of uncontrolled or symptomatic brain or subdural metastases. Inclusion of patients with brain metastases who have completed local therapy and are considered stable by the investigator, or with newly identified asymptomatic brain metastases at screening will be allowed. Use of corticosteroids is allowed if the dose was stable for at least 1 week before the baseline MRI.
13. Patients who are under judicial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method