A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
Recruiting now · Phase 1/Phase 2
Conditions studied: Melanoma, Non-small Cell Lung Cancer, Squamous Cell Carcinoma (Skin), Renal Cell Carcinoma, Merkel Cell Carcinoma, Triple Negative Breast Cancer, Head and Neck Squamous Cell Carcinoma, Gastric Cancer/Gastroesophageal Junction Cancer, High Grade Serous Ovarian Carcinoma
In brief
A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
Key facts
- Study ID
- NCT07115043
- Run by
- AstraZeneca
- People needed
- 60
- Starts
- 2025-07-29
- Expected to finish
- 2029-10-02
- Last updated by the study team
- 2026-07-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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
- 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%.
You may not qualify 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
- 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
- Research Site — Grand Rapids, Michigan, United States (enrolling)
- Research Site — St Louis, Missouri, United States (enrolling)
- Research Site — Pittsburgh, Pennsylvania, United States (enrolling)
- Research Site — Houston, Texas, United States (enrolling)
- Research Site — San Antonio, Texas, United States (enrolling)
- Research Site — Fairfax, Virginia, United States (enrolling)
- Research Site — East Melbourne, Australia (enrolling)
- Research Site — Chūōku, Japan (enrolling)
- Research Site — Kashiwa, Japan (enrolling)
- Research Site — Seoul, South Korea (enrolling)
- Research Site — Seoul, South Korea (enrolling)
- Research Site — Seoul, South Korea
- Research Site — Seoul, South Korea
Full record on ClinicalTrials.gov
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