NCT07115043RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 16 Jul 2025
- Start date
- 29 Jul 2025
- Primary completion date
- 2 Oct 2029
- Lead sponsor
- AstraZeneca
- Diseases
- Triple-negative breast cancer, Head and neck cancer, Kidney cancer, Melanoma, Lung cancer, Gastric and esophageal cancer, Ovarian cancer
- NCT number
- NCT07115043
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 120
- From 29 Jul 2025 to the primary completion date, 2 Oct 2029
- 10 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- Any evidence of:
- Severe or uncontrolled systemic diseases including respiratory, cardiac or tumor-related conditions
- Acute untreated or symptomatic malignant spinal cord compression, or a history of leptomeningeal carcinomatosis.
- Active uncontrolled or chronic infection of hepatitis B, hepatitis C
Lab values
- 1L NSCLC participants with genetic alteration such as EGFR that has a targeted therapy in 1L as per local SoC
Who the study is looking for
- 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
- <!-- -->
- Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | East Melbourne | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | Chūōku | Japan | Recruiting |
| - Coordinator of this site? Confirm its status | Kashiwa | Japan | Recruiting |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| - Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| - Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.