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Clinical Trial · NCT04297748
Bioimaging Study of 89Zr-M7824 in NSCLC
Overview
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.
Sponsor
Olivia Newton-John Cancer Research Institute
Phase
Phase 1/2
Contacts
Hui K Gan, MBBS (PRINCIPAL_INVESTIGATOR)
Andrew M Scott, MBBS (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT04297748Drug / Compound
M7824
Isotope(s):
ZIRCONIUM-89
Radioisotope: Zr89
Theranostic Role: PET Imaging
T1/2 (Half-Life): 78 Hours
Decay Mode: POSITRON β+ (22%), ELECTRON CAPTURE (76%), GAMMA
Energy: max 0.9 MeV, E mean 397 keV, Gamma 511 keV
Range: N/A
Decay Daughters: Y89 (Stable)
Status: Clinical Trials Only
Target(s):
- PD-L1
Ligand Class: Antibodies
Chelator: Desferrioxamine
Eligibility
Inclusion
- 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
- 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)
- Adults (≥ 18 years) with histologically proven advanced NSCLC
- ECOG 0-1
- Measurable disease by RECIST 1.1
Exclusion
- Patients who are unsuitable for chemotherapy in the investigator's judgement
- Has received thoracic radiotherapy \> 30 Gy within 6 months of the dose of study drug
- The participant's tumour harbors an EGFR sensitizing (activating) mutation, ALK translocation, ROS1 rearrangement, or BRAF V600E mutation
- Prior systemic immunotherapy for advanced NSCLC
- Use of anti-cancer therapy including surgery, chemotherapy, immunotherapy, radiotherapy to a non-thoracic site or any investigational therapy within 28 days prior to Study Day 1
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