Substudy 1 - Parts B1 and B2 with CD8+ PET for Carcinoma, Non-Small-Cell Lung

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Research Site, New Haven, CT
Carcinoma, Non-Small-Cell Lung+3 More
AZD8853 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

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.

Eligible Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Urinary Bladder Cancer
  • Colorectal Carcinoma (CRC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 12 Secondary · Reporting Duration: From first documented response to Disease Progression or other End of Study criteria are met (Approximately 1 year)

Month 9
All Substudies: Change in ctDNA from baseline through post-treatment
Month 9
All Substudies: Number and percentage of participants with detectable antidrug antibodies (ADAs) against AZD8853
Month 6
All Substudies: Incidence of AEs leading to discontinuation of AZD8853
Month 9
All Substudies: Area Under the Curve (AUC) of AZD8853
All Substudies: Maximum observed serum concentration (Cmax) of AZD885
Year 1
All Substudies: Progression Free Survival (PFS) per RECIST 1.1
Day 21
All Substudies-Dose Escalation Parts Only: Number of Dose Limiting Toxicities (DLTs)
Year 2
All Substudies: Overall survival (OS)
Month 6
All Substudies: Number of participants with adverse events (AEs)
All Substudies: Number of participants with serious adverse events (SAEs)
Month 6
All Substudies: Disease control rate (DCR) per RECIST 1.1
All Substudies: Overall response rate (ORR) per RECIST 1.1
Month 6
All Substudies: Percent change in target lesion tumor size from baseline per RECIST 1.1
Year 1
All Substudies: Duration of response (DoR) per RECIST 1.1
Month 2
Substudy 1 - Part B: Change in CD8 tumor infiltration in paired biopsies
Month 9
Substudy 1-Parts A & B: Change in circulating GDF15 serum levels

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Substudy 1 - Parts B1 and B2 with CD8+ PET
1 of 2
Substudy 1 - Parts A, B, and C
1 of 2
Experimental Treatment

165 Total Participants · 2 Treatment Groups

Primary Treatment: Substudy 1 - Parts B1 and B2 with CD8+ PET · No Placebo Group · Phase 1 & 2

Substudy 1 - Parts B1 and B2 with CD8+ PET
Drug
Experimental Group · 1 Intervention: Zirconium-89 crefmirlimab berdoxam · Intervention Types: Drug
Substudy 1 - Parts A, B, and C
Drug
Experimental Group · 1 Intervention: AZD8853 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from first documented response to disease progression or other end of study criteria are met (approximately 1 year)
Closest Location: Research Site · New Haven, CT
Photo of New Haven  1Photo of New Haven  2Photo of New Haven  3
1900First Recorded Clinical Trial
176 TrialsResearching Carcinoma, Non-Small-Cell Lung
2948 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
At least 2 prior lines of systemic therapy in the advanced / metastatic setting, including specific therapies defined in the protocol.
You have at least one target lesion per RECIST 1.1.
You have a life expectancy of ≥ 12 weeks.
You have a history of locally advanced, unresectable or metastatic cancer.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.