Bladder Cancer Clinical Trial
A First-in-human Study to Evaluate the Safety and Tolerability of AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours
A Phase I/IIa First-in-human, Open-label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD8853 in Participants with Selected Advanced/Metastatic Solid Tumours.
This study is evaluating the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of AZD8853 in participants with advanced, unresectable or metastatic Non-Small Cell Lung Cancer (NSCLC), Microsatellite Stable Colorectal Cancer (MSS-CRC), Urothelial Carcinoma (UC).
This is a modular study, that includes a master protocol and Substudies.
Substudy 1 will be conducted in 3 parts - Part A: Dose escalation, Part B: Safety expansion and exploratory CD8+ T cell radiopharmaceutical tracer with PET imaging, and Part C: Efficacy expansion.
*Key Inclusion Criteria*
At least one measurable target lesions per RECIST 1.1.
Eastern Cooperative Group (ECOG) of 0-1.
Life expectancy of ≥ 12 weeks
Adequate organ and marrow function as defined in the protocol
Histologically or cytologically confirmed locally advanced, unresectable or metastatic NSCLC, MSS-CRC, or UC.
Documented progression from previous therapy
3.a. At least 1 line of systemic therapy in the advanced / metastatic setting 3.b.Must have received anti-PD-1/anti-PD-L1 agent with or without chemotherapy 3.c. Part B and C: Documented no sensitizing EGFR mutations or ALK fusions/rearrangements
4. MSS-CRC: 4.a. At least 2 prior lines of systemic therapy in the advanced / metastatic setting, including specific therapies defined in the protocol
5. UC: 5.a. At least 1 prior line of systemic therapy in the advanced / metastatic setting, including either a platinum-containing regimen and/or an anti-PD-1 or anti-PD-L1 drug 6. Provision of archival tissue or unstained slides 7. Part B: Willing to provide mandatory biposies at screening and on study 8. Part B-CD8+ PET: At least 1 non-liver lesion suitable for PET imaging
*Key Exclusion Criteria*
Unresolved toxicities ≥ Grade 2 per CTCAE 5.0 from prior therapy, with some exceptions defined in the protocol
Symptomatic CNS metastases or leptomeningeal disease
Active or ongoing infections, or uncontrolled intercurrent illness as defined in the protocol
Active or prior documented autoimmune or inflammatory disorder
Body weight loss of > 10% within 30 days of screening visit
Type 2 diabetes requiring management by metformin, where metformin cannot be switched to another treatment at least 7 days prior to starting study treatment
Must not have had a toxicity from a checkpoint inhibitor that lead to permanent discontinuation of immunotherapy
Participants with brain metastases, unless treated, asymptomatic, stable, and not requiring treatment
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There are 23 Locations for this study
New Haven Connecticut, 06510, United States
Atlanta Georgia, 30322, United States
Iowa City Iowa, 52242, United States
Detroit Michigan, 48201, United States
Saint Louis Missouri, 63110, United States
Las Vegas Nevada, 89169, United States
Providence Rhode Island, 02903, United States
Seattle Washington, 98109, United States
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G 1, Canada
Marseille , 13015, France
Toulouse cedex 9 , 31059, France
Villejuif , 94800, France
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 28027, Spain
Madrid , 28040, Spain
Madrid , 28050, Spain
Pamplona , 31008, Spain
Cambridge , CB2 0, United Kingdom
Glasgow , G12 0, United Kingdom
London , NW3 2, United Kingdom
Newcastle Upon Tyne , NE7 7, United Kingdom
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