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.
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This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 1, 2024 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- AstraZeneca
- Interventions being studied
- Drug: AZD8853; Drug: Zirconium-89 crefmirlimab berdoxam
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- \*Key \
- All Substudies: 1. At least one measurable target lesions per RECIST 1.1. 2. Eastern Cooperative Group (ECOG) of 0-1. 3. Life expectancy of ≥ 12 weeks 4. Adequate organ and marrow function as defined in the protocol Substudy 1: 1. Histologically or cytologically confirmed locally advanced, unresectable or metastatic NSCLC, MSS-CRC, or UC. 2. Documented progression from previous therapy 3. NSCLC: 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
- \
- All Substudies: 1. Unresolved toxicities ≥ Grade 2 per CTCAE 5.0 from prior therapy, with some exceptions defined in the protocol 2. Symptomatic CNS metastases or leptomeningeal disease 3. Active or ongoing infections, or uncontrolled intercurrent illness as defined in the protocol 4. Active or prior documented autoimmune or inflammatory disorder 5. Body weight loss of \> 10% within 30 days of screening visit 6. Type 2 diabetes requiring management by metformin, where metformin cannot be switched to another treatment at least 7 days prior to starting study treatment Substudy 1: 1. Must not have had a toxicity from a checkpoint inhibitor that lead to permanent discontinuation of immunotherapy 2. Participants with brain metastases, unless treated, asymptomatic, stable, and not requiring treatment
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Research SiteAtlanta, Georgia
- Research SiteSt Louis, Missouri
- Research SiteProvidence, Rhode Island
- Research SiteSeattle, Washington
- Research SiteOttawa, Ontario
- Research SiteToronto, Ontario
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 1, 2024. Always confirm current availability with the study team.