TheranosticTrials.org

Clinical Trial · NCT05397171

A First-in-human Study to Evaluate the Safety and Tolerability of AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours

Overview

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.

Sponsor

AstraZeneca

Phase

Phase 1/2

ClinicalTrials.gov

NCT05397171

Drug / Compound

crefmirlimab berdoxam

Isotope(s):
Target(s):
  • CD8 Cells
Ligand Class: Small Proteins and Antibody Fragments
Chelator: DFO

Eligibility

Inclusion

  • Life expectancy of ≥ 12 weeks
  • Body weight loss of \> 10% within 30 days of screening visit
  • Documented progression from previous therapy
  • Histologically or cytologically confirmed locally advanced, unresectable or metastatic NSCLC, MSS-CRC, or UC.
  • Active or prior documented autoimmune or inflammatory disorder
  • \*Key Inclusion Criteria\*All Substudies:
  • 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/rearrangements4\. MSS-CRC: 4.a. At least 2 prior lines of systemic therapy in the advanced / metastatic setting, including specific therapies defined in the protocol5\. 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:
  • Participants with brain metastases, unless treated, asymptomatic, stable, and not requiring treatment
  • NSCLC:
  • Type 2 diabetes requiring management by metformin, where metformin cannot be switched to another treatment at least 7 days prior to starting study treatmentSubstudy 1:
  • Eastern Cooperative Group (ECOG) of 0-1.
  • Must not have had a toxicity from a checkpoint inhibitor that lead to permanent discontinuation of immunotherapy
  • Adequate organ and marrow function as defined in the protocolSubstudy 1:
  • Symptomatic CNS metastases or leptomeningeal disease
  • Active or ongoing infections, or uncontrolled intercurrent illness as defined in the protocol
  • Unresolved toxicities ≥ Grade 2 per CTCAE 5.0 from prior therapy, with some exceptions defined in the protocol
  • At least one measurable target lesions per RECIST 1.1.

Exclusion

Exclusion criteria not yet provided.