A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
Recruiting · NCT07115043 · Interventional (participants receive a specific treatment) · Lead sponsor: AstraZeneca
View the official record on ClinicalTrials.gov →Interventions studied
AZD6750rilvegostomig
What this trial is about
A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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
- 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%.
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
Where it is running
26 locations listed across 5 US states.
- Research Site - Grand Rapids, Michigan, United States
- Research Site - Grand Rapids, Michigan, United States
- Research Site - St Louis, Missouri, United States
- Research Site - St Louis, Missouri, United States
- Research Site - Pittsburgh, Pennsylvania, United States
- Research Site - Pittsburgh, Pennsylvania, United States
- Research Site - Houston, Texas, United States
- Research Site - Houston, Texas, United States
- Research Site - San Antonio, Texas, United States
- Research Site - San Antonio, Texas, United States
- Research Site - Fairfax, Virginia, United States
- Research Site - Fairfax, Virginia, United States
- Research Site - Chūōku, Japan
- Research Site - Chūōku, Japan
- Research Site - East Melbourne, Australia
- Research Site - East Melbourne, Australia
- Research Site - Kashiwa, Japan
- Research Site - Kashiwa, Japan
- Research Site - Seoul, South Korea
- Research Site - Seoul, South Korea
- Research Site - Seoul, South Korea
- Research Site - Seoul, South Korea
- Research Site - Seoul, South Korea
- Research Site - Seoul, South Korea
- Research Site - Seoul, South Korea
- Research Site - Seoul, South Korea