A Phase I/II Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select Advanced or Metastatic Solid Tumors
A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
• Participant ≥ 18 year
• ECOG PS of 0 to 1
• Provision of 'archival' tumor specimen
• At least one measurable lesion according to RECIST v1.1,
• Minimum life expectancy of 12 weeks
• Adequate and stable cardiac function
• Adequate bone marrow, liver and kidney function
• Body weight ≥ 35 kg
• Capable of giving signed informed consent
∙ Module 1 specific inclusion criteria:
∙ • Participants with locally advanced or metastatic select solid tumors (MM, Squamous cell carcinoma of skin, MCC, NSCLC, Head and neck squamous cell carcinoma, Gastric cancer/gastroesophaegeal junction cancer, RCC, HGSOC, Triple negative breast cancer) who have received adequate SoC
∙ Module 2 specific inclusion criteria:
• Participants with Stage IV NSCLC Dose Escalation/Backfills
‣ Have received at least one prior regimen in metastatic setting (2L+ NSCLC). Participants with actionable tumor alterations should have received targeted therapy if locally available OR
⁃ Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.
‣ Dose Expansion
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‣ Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.