Phase
Condition
Solid Tumors
Treatment
[¹⁴C]-BI 907828 mixed with BI 907828 (formulation 1)
BI 907828
[¹⁴C]-BI 907828 mixed with BI 907828 (formulation 2)
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Signed and dated written informed consent in accordance with InternationalConference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislationprior to admission to the trial.
Male patients, age 18-70 years; or women of non-childbearing potential* aged ≥ 18years and ≤ 70 years at the time of signature of the ICF.
*Non-childbearing potential is defined as permanently sterile or post-menopausal.Permanent sterilization methods include hysterectomy, bilateral salpingectomy andbilateral oophorectomy. Tubal ligation is NOT a method of permanent sterilization.Postmenopausal defined as at least 1 year of spontaneous amenorrhea (in questionablecases a blood sample with levels of FSH above 40 U/L or 40 IU/L and estradiol below 30 ng/L or 110.13 pmol/L is confirmatory) without an alternative medical cause.
Histologically or cytologically confirmed diagnosis of an advanced, unresectableand/or metastatic solid tumor.
Patients with measurable or non-measurable disease. Non-evaluable disease isallowed.
Patient who has failed or rejected conventional treatment or for whom no therapy ofproven efficacy exists or who is not eligible for established treatment options.Patient should have exhausted available treatment options known to prolong survivalfor their disease.
BMI of 18.5 to 29.9 kilogram per square meter (kg/m2) at Screening.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
All toxicities related to previous anti-cancer therapies have resolved ≤ CTCAE Grade 1 prior to trial treatment administration (except for alopecia and peripheralneuropathy which must be ≤ Common Terminology Criteria for Adverse Events (CTCAE)Grade 2 and). Note: Patients with chronic grade 2 toxicities that are asymptomaticor adequately managed with stable medication may be eligible with approval from theSponsor.
Further inclusion criteria apply.
Exclusion
Exclusion Criteria:
Patients with known TP53 mutant tumours (Note: testing is not mandatory forinclusion).
Second malignancy currently requiring active therapy (except for hormonal /antihormonal treatment e.g. in prostate or breast cancer).
Received chemo-, immuno-, or molecular-targeted cancer-therapy or investigationaldrug within the past 30 days or within 5 half-life periods (as far as known forinvestigational therapies) prior to the initiation of trial treatment or planning toreceive any of these therapies concomitantly with this trial. This restriction doesnot apply to steroids, bisphosphonates, and hormonal/antihormonal treatment (e.g. inprostate or breast cancer).
Patients who have received radiotherapy within 4 weeks prior to trial entry. Note:Patients receiving limited palliative radiation to non-gastrointestinal areas within 4 weeks prior to trial entry may still be eligibility upon discussion with andconfirmation from the Sponsor.
No ¹⁴C related study medication containing over 0.1 Megabecquerel (MBq) radiation inthe last 12 months prior to dosing in the current study.
Clinical evidence of active brain metastasis or leptomeningeal disease in the past 6months prior to screening.
Irregular defecation pattern (less than once per 2 days) or urinary incontinence (applicable for Cohort 1 (ADME) patients only).
Patient is unwilling to undergo intensive blood sampling or has veins unsuitable forblood sampling or infusion.
Further exclusion criteria apply.
Study Design
Connect with a study center
PRA Hungary Ltd.
Budapest, 1077
HungarySite Not Available
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