A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
About this study
A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
- Condition
- 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
- Tested
- AZD6750, rilvegostomig
- Sponsor
- AstraZeneca
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 19
- Minimum age: 18 years
- Study condition: 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
- 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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Exclusion 15
- 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
13 sites, 13 recruiting
Research Site
East Melbourne, Australia
Research Site
Chūōku, Japan
Research Site
Kashiwa, Japan
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
and 7 more sites on ClinicalTrials.gov
Contact
-
AstraZeneca Clinical Study Information Center
1-877-240-9479 information.center@astrazeneca.com
Potential match only. Final eligibility is determined by the study team.