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Report for Clinical Trial NCT04297748

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Bioimaging Study of 89Zr-M7824 PET Scans in Patients With Advanced or Metastatic NSCLC Receiving M7824 Alone or in Combination With Chemotherapy

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.

NCT04297748 Non-Small Cell Lung Cancer
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

2 Interventions

Name: 89Zirconium-M7824

Description: PET imaging agent
Type: Combination Product
Group Labels: 2

Cohort A Cohort B

Name: M7824

Description: Bifunctional fusion protein intended to block PD-L1 and neutralize TGFbeta simultaneously.
Type: Drug
Group Labels: 2

Cohort A Cohort B


Primary Outcomes

Description: The biodistribution of 89Zr-M7824 will be evaluated by qualitative assessment of organ uptake and clearance from PET imaging following infusion of 89Zr-M7824. Patterns of expected normal tissue uptake due to blood pool activity, and PD-L1 expression, as well as catabolism of 89Zr-M7824, will be assessed.

Measure: Biodistribution of 89Zr-M7824 in NSCLC patients

Time: Cycle 1 - 7 weeks

Secondary Outcomes

Description: Adverse responses of any grade following commencement of treatment will be recorded and quantified.

Measure: Number of participants with 89Zr-M7824 treatment-related adverse events as assessed using CTCAE v5.0.

Time: 0-12 months

Description: Adverse responses of any grade following commencement of treatment will be recorded and quantified.

Measure: Number of participants with M7824 or M7824 combined with chemotherapy treatment-related adverse events as assessed using CTCAE v5.0.

Time: 0-36 months

Other Outcomes

Description: Describe response rates to M7824 monotherapy or M7824 combined with conventional chemotherapy, defined as number of patient achieving a complete disease response, partial disease response or stable disease response determined by medical imaging of tumours.

Measure: Clinical outcomes assessed via response evaluation criteria in solid tumors (RECIST) V1.1

Time: 0-36 months

Description: To determine association of response to M7824 monotherapy with tumour uptake of 89Zr-M7824.

Measure: Correlation of clinical outcome of monotherapy with M7824 (assessed via RECIST) with tumour uptake of 89Zr-M7824 as quantified by PET imaging.

Time: 0-12 months

Description: To determine the association between PD-L1 expression determined by IHC and tumour uptake in a given lesion as measured by 89Zr-M7824 biodistribution.

Measure: Quantification of PD-L1 expression IHC and tumour uptake in a given lesion as measured by 89Zr-M7824 biodistribution.

Time: 0-12 months

Purpose: Treatment

Allocation: Non-Randomized

Crossover Assignment


There is one SNP

SNPs


1 V600E

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 surgery, chemotherapy, immunotherapy, radiotherapy to a non-thoracic site or any investigational therapy within 28 days prior to Study Day 1 - Has received thoracic radiotherapy > 30 Gy within 6 months of the dose of study drug - Previous malignant disease (other than NSCLC) within the last 3 years. --- V600E ---



HPO Nodes


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