An open label Phase I Positron Emission Tomography Imaging study to investigate the bio-distribution and tumor uptake of [89Zr]Zr-BI 905677 in patients with advanced tumors harbouring an RNF43 mutation or R-Spondin Fusio

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main objectives<br /><br>The main objective of this study is to determine the tumour accumulation of<br /><br>[89Zr]Zr-BI 905677 at baseline and during treatment.<br /><br><br /><br>Primary endpoint(s)<br /><br>The primary endpoint is the relative change of SUVpeak (standard uptake value)<br /><br>of [89Zr]Zr-BI 905677 in target tumour lesion(s) from baseline to post BI<br /><br>905677 doses.<br /><br><br /><br>The relative change from baseline of the SUVpeak in target lesions is defined<br /><br>as the average value at each of the last two imaging timepoints of the median<br /><br>relative change from baseline of the SUVpeak in all target lesions.<br /><br><br /><br>The analysis of the primary endpoint will be descriptive and comparisons will<br /><br>be based on<br /><br>baseline (i.e. pre-treatment) values.<br /><br><br /><br>Please also see section 2.1 and 2.2 of the protocol. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>There are no secondary endpoints in this study.<br /><br><br /><br>For further objectives and outcomes, please seen section 2.2 of the protocol. </p><br>