Solid tumors and differen types of cancer
Conditions
Interventions
During this biodistribution study, [89Zr]Zr-BI 905677 will be administered once
alone in Cycle 1.
In Cycle 1, additional cold mass dose of the mAb will be explored if needed for
imaging.
In Cycle
Sponsors
Boehringer Ingelheim
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed advanced, unresectable and/or metastatic solid tumours with a documented RNF43 mutation or R-Spondin fusion 2.Failure to conventional treatment and no therapy of proven efficacy existing or ineligibility for established Treatment options 3. Eastern Cooperative Oncology Group (ECOG) score: 0 to 1 4. At least one Positron emmission tomography (PET)-imageable, evaluable tumor lesion (>=20 mm) according to Revised Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 5. At least one biopsiable tumor lesion 6. Life expectancy of at least 12 weeks after the start of the treatment according to the Investigator*s judgement
Exclusion criteria
Exclusion criteria: 1. Major surgery performed within 4 weeks prior to first Trial treatment or planned within 6 months after Screening 2. Previous or concomitant malignancies other than the one treated in this trial within the last 2 years 3. Osteoporosis >= Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or osteoporotic compression fracture within 12 months prior to informed consent 4. Treatment with an anti-cancer therapy or investigational drug within 28 days or 5 half-lives of the first treatment with the study medication 5. Presence or history of uncontrolled or symptomatic brain or subdural metastases 6. History of human immunodeficiency virus (HIV) infection or an active hepatitis B or C infection 7. History of severe hypersensitivity reactions to monoclonal antibodies or allergy to kanamycin or similar class drugs 8. Women who are pregnant, nursing, or who plan to become pregnant or nursing during the trial or within 6 months after the last dose of study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main objectives The main objective of this study is to determine the tumour accumulation of [89Zr]Zr-BI 905677 at baseline and during treatment. Primary endpoint(s) The primary endpoint is the relative change of SUVpeak (standard uptake value) of [89Zr]Zr-BI 905677 in target tumour lesion(s) from baseline to post BI 905677 doses. The relative change from baseline of the SUVpeak in target lesions is defined as the average value at each of the last two imaging timepoints of the median relative change from baseline of the SUVpeak in all target lesions. The analysis of the primary endpoint will be descriptive and comparisons will be based on baseline (i.e. pre-treatment) values. Please also see section 2.1 and 2.2 of the protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary endpoints in this study. For further objectives and outcomes, please seen section 2.2 of the protocol. | — |
Countries
Netherlands
Outcome results
None listed