Recruiting

AZD6750 for Advanced or Metastatic Solid Tumors

What is being tested

AZD6750

+ rilvegostomig

Drug

Who is being recruted

Squamous Cell Carcinoma of Head and Neck+50

+ Urogenital Diseases

+ Adenocarcinoma

Over 18 Years

+28 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1 & 2

Interventional

Study Start: July 2025

See protocol details

Summary

Principal SponsorAstraZeneca

Study ContactAstraZeneca Clinical Study Information Center

Last updated: December 20, 2025

Sourced from a government-validated database.Claim as a partner

Study start date: July 29, 2025

Actual date on which the first participant was enrolled.

This study is focused on testing a new treatment called AZD6750 for people with advanced or metastatic solid tumors, which are cancers that have spread to other parts of the body. The goal is to assess how safe and effective this new agent is when used alone or combined with other anti-cancer medications. This research is crucial as it could lead to new treatment options for patients with these difficult-to-treat tumors, potentially improving their outcomes and quality of life. Participants in the study will receive AZD6750, which is administered to them in a dose escalation manner, meaning the dosage will gradually increase to determine the safest and most effective amount. Researchers will monitor the safety and effects of the treatment by observing various biological responses and how the drug moves and acts in the body. The study will not only track the drug’s impact on the tumors but also evaluate any side effects experienced, aiming to find a balance where the treatment is most beneficial with the least harm.

Official TitleA 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

NCT07115043

Principal SponsorAstraZeneca

Study ContactAstraZeneca Clinical Study Information Center

Last updated: December 20, 2025

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Squamous Cell Carcinoma of Head and NeckUrogenital DiseasesAdenocarcinomaBreast DiseasesBreast NeoplasmsBronchial NeoplasmsCarcinomaCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungCarcinoma, Renal CellCarcinoma, Squamous CellDigestive System DiseasesDigestive System NeoplasmsDNA Virus InfectionsFemale Urogenital Diseases and Pregnancy ComplicationsGastrointestinal DiseasesGastrointestinal NeoplasmsHead and Neck NeoplasmsInfectionsKidney DiseasesKidney NeoplasmsLung DiseasesLung NeoplasmsMelanomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueRespiratory Tract DiseasesRespiratory Tract NeoplasmsSkin DiseasesSkin NeoplasmsStomach DiseasesStomach NeoplasmsThoracic NeoplasmsTumor Virus InfectionsUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsVirus DiseasesCarcinoma, Merkel CellSkin and Connective Tissue DiseasesNeuroectodermal TumorsCarcinoma, NeuroendocrineNeoplasms, Squamous CellNevi and MelanomasNeuroendocrine TumorsPolyomavirus InfectionsFemale Urogenital DiseasesMale Urogenital DiseasesTriple Negative Breast Neoplasms

Criteria

15 inclusion criteria required to participate

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

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%.

Show More Criteria

13 exclusion criteria prevent from participating

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

Any evidence of: Severe or uncontrolled systemic diseases including respiratory, cardiac or tumor-related conditions

History or planned organ or allogeneic stem cell transplantation.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

AZD6750 administered intravenously (IV) as a single agent

Group II

Experimental

AZD6750 given in combination with rilvegostomig (IV)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 9 locations

Recruiting

Research Site

Grand Rapids, United StatesSee the location

Recruiting

Research Site

San Antonio, United States

Recruiting

Research Site

East Melbourne, Australia

Recruiting

Research Site

Chūōku, Japan

Recruiting

9 Study Centers