Status:
TERMINATED
A Study to Find a Safe and Effective Dose of BI 1701963 Alone and in Combination With BI 3011441 in Patients With Advanced Cancer and a Certain Mutation (Kirsten Rat Sarcoma Viral Oncogene Homologue [KRAS])
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Solid Tumors, KRAS Mutation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a study in adults with advanced cancer (solid tumours including non-small cell lung cancer and colorectal cancer) in whom previous chemotherapy was not successful. People who have a tumour wit...
Eligibility Criteria
Inclusion
- Previously-identified activating Kirsten rat sarcoma viral oncogene homologue (KRAS) mutation in tumour tissue or blood prior to screening. Activating mutations may include but are not limited to: KRAS mutations in expressed region (exon) 2 (G12, G13), exon 3 (A59, Q61) and exon 4 (K117, A146).
- Provision of archival tumour tissue, if available, to confirm retrospectively KRAS mutation status and for biomarker assessment
- At least one target lesion that can be measured per Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1. In patients who only have one target lesion, and a biopsy of the lesion is required, the baseline imaging must be performed at the earliest two weeks after the biopsy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening
- Adequate organ function at screening as follows:
- Absolute neutrophil count (ANC) ≥1.5 x 109/L; hemoglobin ≥9.0 g/dL; platelets ≥100 x 109/L without the use of haematopoietic growth factors or recent transfusion
- Total bilirubin ≤1.5 times the upper limit of normal (ULN), or ≤4 x ULN for patients who are known to have Gilbert's syndrome.
- Creatinine ≤1.5 x ULN. If creatinine is \>1.5 x ULN, patient is eligible if concurrent glomerular filtration rate (GFR) ≥50 mL/min (measured or calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula).
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3 x ULN if no demonstrable liver metastases, or ≤ 5 x ULN if transaminase elevation is attributable to liver metastases.
- Age ≥18 years of age, or over the legal age of consent as required by local legislation at informed consent.
- Recovery from any previous therapy related toxicity to Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤1 at Cycle 1 Day 1 (except for alopecia, stable sensory neuropathy must be CTCAE Grade ≤2 and except for amenorrhea/menstruation related disorders of any grade) before the first dose.
- Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to admission to the trial.
- Further inclusion criteria apply.
Exclusion
- Previous anticancer chemotherapy or anticancer immunotherapy within 3 weeks of the first administration of trial drug. Previous anticancer hormonal treatment within 2 weeks of the first administration of trial drugs.
- Previous treatment with Rat sarcoma (RAS), Mitogen-activated protein kinase (MAPK) or Son of Sevenless 1 (SOS1) targeting agents
- Radiotherapy within 4 weeks prior to start of treatment 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-Assocation (NYHA) classification of ≥3, unstable angina or poorly controlled arrhythmia which are considered clinically relevant by the investigator; myocardial infarction within 6 months prior to start of treatment. Uncontrolled hypertension is defined as: Blood pressure (BP) measured in a rested and relaxed condition, where systolic BP ≥140 mmHg, or diastolic BP ≥90 mmHg, with or without medication.
- Left ventricular ejection fraction (LVEF) \<50 %. Further exclusion criteria apply.
Key Trial Info
Start Date :
April 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04835714
Start Date
April 20 2021
End Date
January 18 2022
Last Update
February 1 2023
Active Locations (4)
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1
Aichi Cancer Center Hospital
Aichi, Nagoya, Japan, 464-8681
2
National Cancer Center Hospital East
Chiba, Kashiwa, Japan, 277-8577
3
National Cancer Center Hospital
Tokyo, Chuo-ku, Japan, 104-0045
4
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, Japan, 135-8550