RecruitingPhase 1Phase 2NCT07115043
A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
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
Sponsor
AstraZeneca
Enrollment
60 participants
Start Date
Jul 29, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
Eligibility
Min Age: 18 Years
Inclusion Criteria16
- 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
- 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 Criteria14
- 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.
- Previous treatment with anti-TIGIT therapy
- L NSCLC participants with genetic alteration such as EGFR that has a targeted therapy in 1L as per local SoC
Interventions
DRUGAZD6750
AZD6750- CD8 guided IL-2
DRUGrilvegostomig
Rilvegostomig- PD1-TIGIT bispecific antibody
Locations(11)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07115043
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