Status:
TERMINATED
A First-in-human Study to Evaluate the Safety and Tolerability of AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
ImaginAb, Inc.
Conditions:
Urinary Bladder Neoplasms
Colorectal Cancer
Eligibility:
All Genders
18-130 years
Phase:
PHASE1
PHASE2
Brief 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 T...
Detailed Description
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...
Eligibility Criteria
Inclusion
- \*Key Inclusion Criteria\*
- All Substudies:
- 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
- Substudy 1:
- Histologically or cytologically confirmed locally advanced, unresectable or metastatic NSCLC, MSS-CRC, or UC.
- Documented progression from previous therapy
- NSCLC:
- 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:
- 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
- Substudy 1:
- 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
Exclusion
Key Trial Info
Start Date :
June 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT05397171
Start Date
June 7 2022
End Date
June 6 2023
Last Update
October 1 2024
Active Locations (6)
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1
Research Site
Atlanta, Georgia, United States, 30322
2
Research Site
St Louis, Missouri, United States, 63110
3
Research Site
Providence, Rhode Island, United States, 02903
4
Research Site
Seattle, Washington, United States, 98109