Brief Title: AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

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

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION