Recruiting

AZD6750 for Advanced or Metastatic Solid Tumors

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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, 2025Actual 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Squamous Cell Carcinoma of Head and Neck
Urogenital Diseases
Adenocarcinoma
Breast Diseases
Breast Neoplasms
Bronchial Neoplasms
Carcinoma
Carcinoma, Bronchogenic
Carcinoma, Non-Small-Cell Lung
Carcinoma, Renal Cell
Carcinoma, Squamous Cell
Digestive System Diseases
Digestive System Neoplasms
DNA Virus Infections
Female Urogenital Diseases and Pregnancy Complications
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Infections
Kidney Diseases
Kidney Neoplasms
Lung Diseases
Lung Neoplasms
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Skin Diseases
Skin Neoplasms
Stomach Diseases
Stomach Neoplasms
Thoracic Neoplasms
Tumor Virus Infections
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Virus Diseases
Carcinoma, Merkel Cell
Skin and Connective Tissue Diseases
Neuroectodermal Tumors
Carcinoma, Neuroendocrine
Neoplasms, Squamous Cell
Nevi and Melanomas
Neuroendocrine Tumors
Polyomavirus Infections
Female Urogenital Diseases
Male Urogenital Diseases
Triple 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

AZD6750- CD8 guided IL-2
Group II
Experimental
AZD6750 given in combination with rilvegostomig (IV)

AZD6750- CD8 guided IL-2

Rilvegostomig- PD1-TIGIT bispecific antibody
Study Objectives
Primary Objectives

To assess the safety and tolerability, characterize the DLTs, and determine the MTD and RP2D(s) of AZD6750 as a single agent and in combination with other anti-cancer agents as specified in each respective module

To assess the preliminary anti-tumor activity of AZD6750 in combination with other anti-cancer agents.
Secondary Objectives

To assess immunomodulatory biomarker PD-L1 at baseline and on treatment as a single agent and in combination with other anti-cancer agents as specified in each respective module

To assess the incidence of anti-drug antibodies (ADA) against AZD6750 in serum and in combination with other anti-cancer agents as specified in each respective module

To assess the preliminary anti-tumor activity of AZD6750 alone and in combination with other anti-cancer agents.

To assess the plasma concentration of AZD6750 as a single agent and in combination with other anti-cancer agents as specified in each respective module. Each cycle is 28 days or 21 days depending on Module/dosing schedule)

To assess the Area Under Curve (AUC) of AZD6750 as a single agent and in combination with other anti-cancer agents as specified in each respective module. Each cycle is 28 days or 21 days depending on Module/dosing schedule.

To assess the time to maximum plasma concentration of AZD6750 as a single agent and in combination with other anti-cancer agents as specified in each respective module. Each cycle is 28 days or 21 days depending on Module/dosing schedule.

To assess the clearance of AZD6750 as a single agent and in combination with other anti-cancer agents as specified in each respective module. Each cycle is 28 days or 21 days depending on Module/dosing schedule.

To assess the PK half-time of AZD6750 as a single agent and in combination with other anti-cancer agents as specified in each respective module. Each cycle is 28 days or 21 depending on Module/dosing schedule.

To assess the minimum observed concentration (Cmin) of AZD6750 as a single agent and in combination with other anti-cancer agents as specified in each respective module. Each cycle is 28 days or 21 days depending on Module/dosing schedule.

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 SiteGrand Rapids, United StatesSee the location
Recruiting
Research SiteSan Antonio, United States
Recruiting
Research SiteEast Melbourne, Australia
Recruiting
Research SiteChūōku, Japan
Recruiting
9 Study Centers
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