Phase
Condition
Neoplasms
Treatment
BI 907828
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provision of signed and dated, written informed consent form ICF in accordance withICH-GCP and local legislation prior to any trial-specific procedures, sampling, oranalyses.
Pathologically documented, advanced solid tumors.
Patients fulfilling one or more of the following criteria:
Radiologically documented disease progression or relapse
Patients who are not eligible to receive standard of care treatments, and forwhom no proven treatments exist.
Patients with MDM2 amplified sarcomas who require first line treatment (for PhIb/dose expansion - Cohort 1 only).
Patients with MDM2 amplified sarcomas may fulfil any one of the above three criteriato be considered eligible.
Phase Ia (dose escalation) only:
Patient has a tumor with either a known TP53 wild type status, or unknown TP53status, and regardless of MDM2 amplification status, at the time of study entry.
Phase Ib (expansion phase) only:
Cohort 1: TP53 wt and MDM2-amplified sarcoma with advanced/metastatic disease at anyline of therapy. If TP53 status is not available during screening, the patient maybe included with unknown TP53 status if a tissue sample is submitted for centrallaboratory assessment. If TP53 status cannot be evaluated, the patient may beincluded if agreed between the Investigator and Sponsor.
Cohort 2: TP53 wt and MDM2- amplified NSCLC, urothelial, gastric, biliary tract (including cholangiocarcinoma, intra- and extrahepatic biliary tree, gall blanderand ampulla of vater) or pancreatic solidPDAC tumors who have had at least oneprevious line of therapy for advanced/metastatic disease. If TP53 status cannot beevaluated the patient may be included if agreed between the Investigator and Sponsor
Phase Ia (dose escalation) only:
Patient with either measurable or non-measurable disease.
Non-evaluable disease allowed.
Phase Ib (expansion phase) only:
At least one target lesion that can be accurately measured per RECIST v.1.1.
Phase Ia:
Patient must be willing to undergo blood sampling for PK, pharmacodynamic,biomarker, and PGx analyses.
Phase Ib:
Patient must be willing to undergo tumor biopsy sampling for pharmacodynamicanalyses and blood sampling for PK, pharmacodynamics, and biomarker analyses.
Willingness to provide a fresh tumor tissue sample obtained after relapse/progression during or after prior therapy. In case a fresh biopsy cannot be obtained (e.g. inaccessible lesions or patient safety concern), an archived specimen,collected before screening within 12 months of enrollment, may be submitted. Ifthese requirements cannot be met, then the patient may be allowed to enter the studyat Sponsor discretion, after agreement between the Investigator and Sponsor.
Further inclusion criteria apply
Exclusion
Exclusion Criteria:
Previous administration of BI 907828 (brigimadlin) or any other MDM2-p53 or MDMX (MDM4)-p53 antagonist.
Known TP53 mutant tumor.
Symptomatic metastases from non-brain tumors. Note: Patients with previously treatedbrain metastases may participate provided they are stable, without evidence ofprogression by imaging (using the identical imaging modality for each assessment,either MRI or computed tomography (CT) scan), for at least four weeks prior to thefirst dose of trial treatment, and any neurologic symptoms have returned tobaseline; have no evidence of new or enlarging brain metastases. Patients oncorticosteroids must have a stable dose for at least 5 days prior to baseline MRI.
Patients with history of bleeding diathesis.
Major surgery (major according to the Investigator's assessment) performed within 12weeks prior to start of study treatment, or planned within 12 months after screening (e.g. hip replacement).
Any other documented active or suspected malignancy or history of malignancy within 3 years prior to screening, except appropriately treated basal cell carcinoma of theskin or in situ carcinoma of uterine cervix, or other local tumors considered curedby local treatment.
Patients who must or wish to continue the intake of restricted medications or anydrug considered likely to interfere with the safe conduct of the trial.
Further exclusion criteria apply.
Study Design
Connect with a study center
Brussels - UNIV Saint-Luc
Bruxelles, 1200
BelgiumSite Not Available
UZ Leuven
Leuven, 3000
BelgiumSite Not Available
The Ottawa Hospital
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
Rigshospitalet, København
København Ø, 2100
DenmarkSite Not Available
Helios Klinikum Berlin-Buch
Berlin, 13125
GermanySite Not Available
Universitätsmedizin Göttingen, Georg-August-Universität
Göttingen, 37075
GermanySite Not Available
Universitätsklinikum Köln (AöR)
Köln, 50937
GermanySite Not Available
Universitätsklinikum Tübingen
Tübingen, 72076
GermanySite Not Available
Sourasky Medical Center
Tel Aviv, 6423906
IsraelSite Not Available
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045
JapanSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofActive - Recruiting
Severance Hospital
Seoul, 03722
Korea, Republic ofSite Not Available
MED POLONIA SP Z O O, Clinical Trials Department,Poznan
Poznan, 60-693
PolandSite Not Available
Oncology Center-Maria Sklodowska-Curie Institute
Warsaw, 02-781
PolandSite Not Available
Hospital Clínic de Barcelona
Barcelona, 08036
SpainSite Not Available
Hospital Vall d'Hebron
Barcelona, 08035
SpainSite Not Available
Hospital Vall d'Hebron-Barcelona-47683
Barcelona, 08035
SpainSite Not Available
Fundación Jiménez Díaz
Madrid, 28040
SpainSite Not Available
Hospital Clínico de Santiago
Santiago de Compostela, 15706
SpainSite Not Available
Karolinska Comprehensive Cancer Center
Stockholm, 171 76
SwedenSite Not Available
Sarcoma Oncology Center
Santa Monica, California 90403
United StatesSite Not Available
Yale University School of Medicine
New Haven, Connecticut 06511
United StatesSite Not Available
University of Florida
Gainesville, Florida 32610
United StatesSite Not Available
Florida Cancer Specialists
Sarasota, Florida 34232
United StatesSite Not Available
Florida Cancer Specialists-Sarasota-61670
Sarasota, Florida 34232
United StatesSite Not Available
Norton Cancer Institute, Downtown
Louisville, Kentucky 40202
United StatesSite Not Available
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesSite Not Available
START Midwest
Grand Rapids, Michigan 49546
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
SCRI Oncology Partners
Nashville, Tennessee 37203
United StatesSite Not Available
Tennessee Oncology, PLLC
Nashville, Tennessee 37203
United StatesActive - Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
University of Wisconsin
Madison, Wisconsin 53792
United StatesSite Not Available
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