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Testing AZD6750 safety in adults with selected 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

Phase1; Phase2 Interventional AstraZeneca · NCT07115043

This trial tests whether AZD6750, a CD8-guided IL-2 medicine given alone or with other cancer drugs, is safe and how it behaves in adults with certain advanced or metastatic solid tumors.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment60 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsimmunotherapy, prednisone
Locations11 sites (Grand Rapids, Michigan and 10 other locations)
Trial IDNCT07115043 on ClinicalTrials.gov

What this trial studies

This open-label Phase 1/2 study uses a dose-escalation and expansion design to define the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of AZD6750 alone and in combination with other anti-cancer agents. Participants must have selected advanced or metastatic solid tumors and meet standard eligibility requirements such as ECOG 0–1, measurable disease per RECIST v1.1, and adequate organ function. The trial includes collection of archival tumor tissue and serial safety and biomarker assessments to guide dose selection and expansion cohorts. Sites for enrollment are in the United States and the sponsor is AstraZeneca.

Who should consider this trial

Good fit: Adults (≥18) with selected advanced or metastatic solid tumors such as melanoma, NSCLC, renal cell carcinoma, squamous cell carcinoma of the skin, or Merkel cell carcinoma who have ECOG performance status 0–1, measurable disease, adequate organ function, and available archival tumor tissue are the intended candidates.

Not a fit: Patients with poor performance status (ECOG >1), inadequate organ function, life expectancy under 12 weeks, lacking measurable disease or required tissue samples, or whose disease is better treated with established standard therapies are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, AZD6750 could provide a new immune‑based treatment that selectively stimulates CD8 T cells to shrink tumors or delay progression in some patients with advanced solid tumors.

How similar studies have performed: Engineered and tumor-targeted IL-2 approaches have shown encouraging signals in early‑phase studies but CD8‑guided IL-2 agents like AZD6750 are a relatively novel strategy with limited prior clinical data.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

  1. 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
  2. Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.

     Dose Expansion

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  1. 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 this trial is running

Grand Rapids, Michigan and 10 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions MelanomaNon-small Cell Lung CancerSquamous Cell CarcinomaRenal Cell CarcinomaMerkel Cell CarcinomaTriple Negative Breast CancerHead and Neck Squamous Cell CarcinomaGastric Cancer/Gastroesophageal Junction Cancer
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.