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RecruitingLast updated: 19 September 2025

A study investigating safety of a new drug (AZD6750) when given alone and in combination with other anti-cancer treatments in people with select advanced or metastatic solid cancers.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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Clinical summary

Summary

This study aims to understand the safety and efficacy of a new drug (AZD6750) in people with select advanced or metastatic solid cancers. The study will have two Modules.

Module 1 consists of treatment with AZD6750 administered intravenously (IV) and will enrol people with certain locally advanced or metastatic solid cancers who have received prior adeqaue standard of care treatment.

Module 2 is a combination arm that will investigate the effectiveness of AZD6750 in combination with rilvegostomig immunotherapy (IV), and will enrol people with Stage IV non-small cell lung cancer (NSCLC).

Please note,

Module 1 will enrol people with locally advanced or metastatic select solid tumors (MM, Squamous cell carcinoma of skin, MCC, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), Gastric cancer/gastroesophaegeal junction cancer, renal cell carcinoma (RCC), HGSOC, and triple negative breast cancer) who have received adequate standard of care (SoC) treatment. 

Module 2 will enrol participants with Stage IV NSCLC who either received at least one line of therapy in metastatic setting or are treatment naïve in metastatic setting and have a PD-L1 expression ≥ 1%. 

 

Conditions

This trial is treating people with select advanced or metastatic solid cancers.

Eligibility

Inclusion

  • 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

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

Exclusion

  • 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

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

AstraZeneca

Scientific Title

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

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