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
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
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
Participants with Stage IV NSCLC Dose Escalation/Backfills
1. 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
2. Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.
Dose Expansion
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1. Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.
You may not be if
Any evidence of:
Severe or uncontrolled systemic diseases including respiratory, cardiac or tumor-related conditions
History or planned organ or allogeneic stem cell transplantation.
Active or prior documented autoimmune or inflammatory disorders, within the past 3 years
Any prior toxicities that led to permanent discontinuation of prior immunotherapy
