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Brief Title: 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

INTRODUCTION

  • Org Study ID: D9450C00001
  • Secondary ID: 2021-005438-41
  • NTC ID: NCT05397171
  • Sponsor: AstraZeneca

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 Tumours.

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), 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.

  • Overall Status
    Recruiting
  • Start Date
    June 7, 2022
  • Phase
    Phase 1, Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: All Substudies-Dose Escalation Parts Only: Number of Dose Limiting Toxicities (DLTs)

Primary Outcome 1 - Timeframe: From Cycle 1 Day 1 to end of Cycle 1 (21 days)

Primary Outcome 2 - Measure: All Substudies: Number of participants with adverse events (AEs)

Primary Outcome 2 - Timeframe: From Informed Consent through 90 days after the last dose of AZD8853 [about 6 months]

Primary Outcome 3 - Measure: All Substudies: Number of participants with serious adverse events (SAEs)

Primary Outcome 3 - Timeframe: From Informed Consent through 90 days after the last dose of AZD8853 [about 6 months]

Primary Outcome 4 - Measure: All Substudies: Incidence of AEs leading to discontinuation of AZD8853

Primary Outcome 4 - Timeframe: From Cycle 1 Day 1 through 90 days after the last dose of AZD8853 [about 6 months] [Each cycle is of 21 Days]

CONDITION

  • Urinary Bladder Neoplasms
  • Colorectal Cancer
  • Carcinoma
  • Non-Small-Cell Lung

ELIGIBILITY

*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:
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:
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

Gender: All

Minimum Age: 18 Years

Maximum Age: 130 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

LOCATION

Facility Status Contact
Facility: Research Site
Atlanta, Georgia 30322
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Saint Louis, Missouri 63110
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Providence, Rhode Island 02903
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Seattle, Washington 98109
United States
Status: Recruiting Contact: N/A