A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors

July 6, 2026 updated by: AstraZeneca

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

A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • East Melbourne, Australia, 3002
        • Recruiting
        • Research Site
  • Japan
      • Chūōku, Japan, 104-0045
        • Recruiting
        • Research Site
      • Kashiwa, Japan, 227-8577
        • Recruiting
        • Research Site
  • South Korea
      • Seoul, South Korea, 03080
        • Recruiting
        • Research Site
      • Seoul, South Korea, 06351
        • Recruiting
        • Research Site
      • Seoul, South Korea, 3722
        • Not yet recruiting
        • Research Site
      • Seoul, South Korea, 5505
        • Not yet recruiting
        • Research Site
  • United States
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • Research Site
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Research Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • Research Site
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Research Site
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

    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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Module 1
AZD6750 administered intravenously (IV) as a single agent
Drug: AZD6750
AZD6750- CD8 guided IL-2
Experimental: Module 2
AZD6750 given in combination with rilvegostomig (IV)
Drug: AZD6750
AZD6750- CD8 guided IL-2
Drug: rilvegostomig
Rilvegostomig- PD1-TIGIT bispecific antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety- Part 1A & Part 2A (dose escalation) and Part 2B (dose expansion)
Time Frame: Measured from the informed consent until Day 90 post-last dose.
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
Measured from the informed consent until Day 90 post-last dose.
Efficacy- Part 2B only (dose expansion)
Time Frame: Measured every 6 weeks for 48 weeks and every 12 weeks thereafter from first dose until disease progression or death in the absence of disease progression(approximately 2 years)
To assess the preliminary anti-tumor activity of AZD6750 in combination with other anti-cancer agents.
Measured every 6 weeks for 48 weeks and every 12 weeks thereafter from first dose until disease progression or death in the absence of disease progression(approximately 2 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacodynamic- Part 1A & Part 2A (dose escalation) and Part B (dose expansion)
Time Frame: Measured with baseline and On-treatment biopsy. On-treatment biopsy is planned during Cycle 2 during Cycle 2 (each cycle is 28 days or 21 days depending on Module/dosing schedule)
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
Measured with baseline and On-treatment biopsy. On-treatment biopsy is planned during Cycle 2 during Cycle 2 (each cycle is 28 days or 21 days depending on Module/dosing schedule)
Immunogenicity- Part 1A & 2A (dose escalation) and Part 2B (dose expansion)
Time Frame: Measured from pre-infusion on Cycle 1 up to Day 28 post last dose. Each cycle is 28 days or 21 days depending on Module/dosing schedule).
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
Measured from pre-infusion on Cycle 1 up to Day 28 post last dose. Each cycle is 28 days or 21 days depending on Module/dosing schedule).
Efficacy (Part 1A and 2A)
Time Frame: Measured every 6 weeks for 48 weeks and every 12 weeks thereafter thereafter from first dose until disease progression or death in the absence of disease progression (approximately 2 years)
To assess the preliminary anti-tumor activity of AZD6750 alone and in combination with other anti-cancer agents.
Measured every 6 weeks for 48 weeks and every 12 weeks thereafter thereafter from first dose until disease progression or death in the absence of disease progression (approximately 2 years)
PK Maximum plasma concentration (Cmax)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)
Time Frame: Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals
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)
Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals
PK Area Under Curve (AUC)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)
Time Frame: Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals
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.
Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals
PK Time to maximum plasma concentration (tmax)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)
Time Frame: Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals
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.
Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals
PK Clearance- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)
Time Frame: Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals
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.
Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals
PK Half-life- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)
Time Frame: Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals
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.
Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals
PK Minimum observed concentration (Cmin)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)
Time Frame: Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals
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.
Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2025

Primary Completion (Estimated)

October 2, 2029

Study Completion (Estimated)

October 2, 2029

Study Registration Dates

First Submitted

July 16, 2025

First Submitted That Met QC Criteria

August 4, 2025

First Posted (Actual)

August 11, 2025

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

July 6, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D7350C00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.

Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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