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A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors

NCT07115043 · AstraZeneca
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Official title
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
About this study
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
Eligibility criteria
Inclusion criteria: * 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 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 <!-- --> 1. Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%. Exclusion criteria: * 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 * Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anti-cancer therapy * Brain metastases unless treated, asymptomatic, stable, and not requiring continuous corticosteroids * Acute untreated or symptomatic malignant spinal cord compression, or a history of leptomeningeal carcinomatosis. * Active uncontrolled or chronic infection of hepatitis B, hepatitis C * Prior history of Grade ≥ 3 non-infectious pneumonitis. * Participant requires chronic immunosuppressive therapy (including steroids \> 10 mg prednisone/day or equivalent). * Receipt of live attenuated vaccine within 30 days. Module 2 specific exclusion criteria: * Previous treatment with anti-TIGIT therapy * 1L NSCLC participants with genetic alteration such as EGFR that has a targeted therapy in 1L as per local SoC
Study design
Enrollment target: 60 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-07-29
Estimated completion: 2029-10-02
Last updated: 2026-04-23
Interventions
Drug: AZD6750Drug: rilvegostomig
Primary outcomes
  • Safety- Part 1A & Part 2A (dose escalation) and Part 2B (dose expansion) (Measured from the informed consent until Day 90 post-last dose.)
  • Efficacy- Part 2B only (dose expansion) (Measured every 6 weeks for 48 weeks and every 12 weeks thereafter from first dose until disease progression or death in the absence of disease progression(approximately 2 years))
Sponsor
AstraZeneca · industry
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
All locations (11)
Research SiteRecruiting
Grand Rapids, Michigan, United States
Research SiteRecruiting
St Louis, Missouri, United States
Research SiteRecruiting
Pittsburgh, Pennsylvania, United States
Research SiteRecruiting
Houston, Texas, United States
Research SiteRecruiting
San Antonio, Texas, United States
Research SiteRecruiting
Fairfax, Virginia, United States
Research SiteRecruiting
East Melbourne, Australia
Research SiteRecruiting
Chūōku, Japan
Research SiteRecruiting
Kashiwa, Japan
Research SiteRecruiting
Seoul, South Korea
Research SiteNot Yet Recruiting
Seoul, South Korea
A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors · TrialPath