A First-in-human Study to Evaluate the Safety and Tolerability of AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours
Colon/Rectal Cancer
Lung Cancer
18 - 130 Years, Male and Female
D9450C00001 (primary)
NCI-2022-04992
2021-005438-41
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.
Objectives
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.
Eligibility
- *Key Inclusion Criteria*
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 Exclusion Criteria*
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
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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