Bioimaging Study of 89Zr-M7824 in NSCLC (NCT04297748) | Clinical Trial Compass
TerminatedPhase 1/2
Bioimaging Study of 89Zr-M7824 in NSCLC
Stopped: Efficacy finding
Australia5 participantsStarted 2020-06-01
Plain-language summary
This is a bioimaging study of 89Zr-M7824 PET scans in patients with advanced or metastatic non-small cell lung cancer who will be receiving M7824 alone or with standard of care chemotherapy. M7824 is a bifunctional fusion protein that combines an anti-PD-L1 antibody and the extracellular domain of TGFβ receptor II (TGFβRII) as a TGFβ neutralizing 'trap', into a single molecule.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Adults (≥ 18 years) with histologically proven advanced NSCLC
* PD-L1 positive staining in \> 1% of tumour cells in archival or fresh tissue (may be modified for Cohort B to require PDL1-high status and/or PD-L1 status to be tested on fresh tissue obtained a study entry, based on evaluation of data from Cohort A)
* Measurable disease by RECIST 1.1
* ECOG 0-1
* Expected survival more than 3 months
* Adequate organ function. Out of range values that are not clinically significant will be permitted, except for the following laboratory parameters, which must be within the ranges specified:
Hemoglobin ≥ 9 g/dL Neutrophils ≥ 1.5 x 109/L Platelets ≥ 100 x 109/L INR ≤ 1.4 Serum creatinine ≤1.3 x ULN Estimated creatinine clearance ≥ 30 ml/min according to the Cockcroft Gault formula or local normal range Serum AST and ALT ≤2.5 x ULN Serum bilirubin ≤ 1.5 x ULN Available archived formalin-fixed paraffin embedded or frozen tumour tissue; or consents to tumour biopsy at enrolment (the latter is strongly preferred) Presence of a suitable reference tumour lesion for PET imaging i.e. measuring \> 1.5cm and not located in the mediastinum
Exclusion Criteria:
* Prior systemic immunotherapy for advanced NSCLC
* Patients who are unsuitable for chemotherapy in the investigator's judgement
* The participant's tumour harbors an EGFR sensitizing (activating) mutation, ALK translocation, ROS1 rearrangement, or BRAF V600E mutation
* Use of anti-cancer therapy including surger…
What they're measuring
1
Biodistribution of 89Zr-M7824 in NSCLC patients
Timeframe: Cycle 1 - 7 weeks
Trial details
NCT IDNCT04297748
SponsorOlivia Newton-John Cancer Research Institute