This study aims to find the best dose of BI 907828 in patients with different types of advanced cancer (solid tumors)
- Conditions
- Advanced or metastatic solid tumors
- Registration Number
- JPRN-jRCT2080223999
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- recruiting
- Sex
- All
- Target Recruitment
- 200
1. Pathologically documented, advanced solid tumors.
2. Patients fulfilling one or more of the following criteria:
a. Radiologically documented disease progression or relapse
b. Patients who are not eligible to receive standard of care treatments, and for whom no proven treatments exist.
c. Patients with MDM2 amplified sarcomas who require first line treatment (for Ph Ib/dose expansion - Cohort 1 only).
Patients with MDM2 amplified sarcomas may fulfil any one of the above three criteria to be considered eligible.
3. a. Phase Ia (dose escalation) only:Patient has a tumor with either a known TP53 wild type status, or unknown TP53 status, and regardless of MDM2 amplification status, at the time of study entry.
b. Phase Ib (expansion phase) only:
- Cohort 1: TP53 wt and MDM2-amplified sarcoma with advanced/metastatic disease at any line of therapy. If TP53 status is not available during screening, the patient may be included with unknown TP53 status if a tissue sample is submitted for central laboratory assessment. If TP53 status cannot be evaluated, the patient may be included 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 blander and ampulla of vater) or pancreatic solidPDAC tumors who have had at least one previous line of therapy for advanced/metastatic disease. If TP53 status cannot be evaluated the patient may be included if agreed between the Investigator and Sponsor
1. Known TP53 mutant tumor.
2. Previous administration of BI 907828 or any other MDM2-p53 or MDMX (MDM4)-p53 antagonist.
3. Symptomatic brain metastases from non-brain tumors. Note: Patients with previously treated brain metastases may participate but treated brain lesion could not be used as target lesion.
4. Patients with history of bleeding diathesis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method