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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07115043




Registration number
NCT07115043
Ethics application status
Date submitted
16/07/2025
Date registered
11/08/2025
Date last updated
27/08/2025

Titles & IDs
Public title
A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
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
Secondary ID [1] 0 0
D7350C00001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Non-small Cell Lung Cancer 0 0
Squamous Cell Carcinoma (Skin) 0 0
Renal Cell Carcinoma 0 0
Merkel Cell Carcinoma 0 0
Triple Negative Breast Cancer 0 0
Head and Neck Squamous Cell Carcinoma 0 0
Gastric Cancer/Gastroesophageal Junction Cancer 0 0
High Grade Serous Ovarian Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Head and neck
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZD6750
Treatment: Drugs - rilvegostomig

Experimental: Module 1 - AZD6750 administered intravenously (IV) as a single agent

Experimental: Module 2 - AZD6750 given in combination with rilvegostomig (IV)


Treatment: Drugs: AZD6750
AZD6750- CD8 guided IL-2

Treatment: Drugs: rilvegostomig
Rilvegostomig- PD1-TIGIT bispecific antibody
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety- Part 1A & Part 2A (dose escalation) and Part 2B (dose expansion)
Timepoint [1] 0 0
Measured from the informed consent until Day 90 post-last dose.
Primary outcome [2] 0 0
Efficacy- Part 2B only (dose expansion)
Timepoint [2] 0 0
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 [1] 0 0
Pharmacodynamic- Part 1A & Part 2A (dose escalation) and Part B (dose expansion)
Timepoint [1] 0 0
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)
Secondary outcome [2] 0 0
Immunogenicity- Part 1A & 2A (dose escalation) and Part 2B (dose expansion)
Timepoint [2] 0 0
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).
Secondary outcome [3] 0 0
Efficacy (Part 1A and 2A)
Timepoint [3] 0 0
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)
Secondary outcome [4] 0 0
PK Maximum plasma concentration (Cmax)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)
Timepoint [4] 0 0
Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals
Secondary outcome [5] 0 0
PK Area Under Curve (AUC)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)
Timepoint [5] 0 0
Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals
Secondary outcome [6] 0 0
PK Time to maximum plasma concentration (tmax)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)
Timepoint [6] 0 0
Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals
Secondary outcome [7] 0 0
PK Clearance- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)
Timepoint [7] 0 0
Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals
Secondary outcome [8] 0 0
PK Half-life- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)
Timepoint [8] 0 0
Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals
Secondary outcome [9] 0 0
PK Minimum observed concentration (Cmin)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)
Timepoint [9] 0 0
Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals

Eligibility
Key inclusion 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%.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/07/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
9/04/2029
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Michigan
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
Japan
State/province [3] 0 0
Chuoku
Country [4] 0 0
Japan
State/province [4] 0 0
Kashiwa

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07115043