A Study to Test Different Doses of BI 1701963 in Combination With Irinotecan in People With Advanced Bowel Cancer With Kirsten Rat Sarcoma Viral Oncogene Homologue (KRAS) Mutation
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Lead
Boehringer Ingelheim
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patient must have a confirmed activating KRAS mutation in CRC tumour tissue by local test. Activating mutations include but are not limited to: KRAS mutations in exon 2 (G12, G13), exon 3 (A59, Q61) and exon 4 (K117, A146)
Patients must have a histological or cytological diagnosis of CRC
Patients must have received at least first-line chemotherapy (oxaliplatin/ 5-Fluorouracil (5-FU)/ capecitabine et al treatment failure) for unresectable locally advanced or metastatic CRC
Must have at least one target lesion that can be accurately measured per RECIST version 1.1
Must have Eastern Cooperative Oncology Group score of 0 or 1
Must show adequate organ function defined as all of the following:
1. Absolute neutrophil count (ANC) ≥1.5 x 109/L; haemoglobin ≥9.0 g/dL; platelets ≥100 x 109/L without the use of hematopoietic growth factors within 4 weeks of start of Trial medication.
2. Total bilirubin ≤1.5 x Upper Limited of Normal (ULN), or ≤4 x ULN for patients who are known to have Gilbert's syndrome
4. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤3 x ULN if no demonstrable liver metastases, or otherwise ≤5 x ULN
For patients participating in the combination dose escalation and expansion parts (Part B and C), must be eligible to receive treatment with irinotecan in accordance with the local label including Summary of Product Characteristics (SmPC), U.S. PI or Chinese Label
Must be at least 18 years of age at screening
Must have recovered from any previous therapy related toxicity to CTCAE grade ≤1 before the first dose (except for alopecia; stable sensory neuropathy must be CTCAE grade ≤2)
Signed and dated written informed consent in accordance with good clinical practice and local legislation prior to admission to the trial
You may not be if
Previous anticancer chemotherapy, anticancer immunotherapy, and/or other anticancer biologic therapy within 3 weeks of the first administration of trial drug. Previous anticancer hormonal therapy within 2 weeks of first administration of trial drug
Previous treatment with a RAS, Mitogen-activated protein kinase (MAPK) or Son of Sevenless 1 (SOS1) targeting agent
For patients participating in the combination dose escalation and expansion parts (Part B and C only): Previous treatment with irinotecan
Radiotherapy within 4 weeks except as follows
* Palliative radiotherapy to regions other than the chest is allowed up to 2 weeks prior to start of treatment
* Single dose palliative radiotherapy for symptomatic metastasis within 2 weeks prior to start of treatment may be allowed but must be discussed with the sponsor
Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to start of treatment or planned during the projected course of the trial, e.g. hip replacement
Previous treatment with any investigational agent(s) or targeted treatment within 28 days prior to start of treatment
Known history of hypersensitivity to any of the excipients of BI 1701963 tablets
History or presence of cardiovascular abnormalities such as uncontrolled Hypertension, congestive heart failure New York Heart Association (NYHA) classification of ≥3, unstable angina or poorly controlled arrhythmia which are considered as clinically relevant by the investigator; Myocardial infarction within 6 months prior to start of treatment
Left ventricular ejection fraction (LVEF) \<50%
Congenital long QT prolongation syndrome or mean resting corrected QT interval (QTcF) \>470 msec
Clareo Health | A Study to Test Different Doses of BI 1701963 in Combination With Irinotecan in People With Advanced Bowel Cancer With Kirsten Rat Sarcoma Viral Oncogene Homologue (KRAS) Mutation
