MelanomaPhase 1/2NCT07115043
A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing AZD6750 and rilvegostomig in people with Melanoma and Non-small Cell Lung Cancer, run by AstraZeneca at 13 sites in 4 countries.
Trial summary
A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Non-small Cell Lung Cancer, Squamous Cell Carcinoma (Skin)
- What is being tested?
- AZD6750 and rilvegostomig
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 13 sitesin 4 countries
- Study dates
- 29 Jul 2025to 2 Oct 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 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
- Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.
- Dose Expansion
- <!-- -->
- Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.
Who cannot join
- 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
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- 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
Trial locations and contacts
13 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
13 sites in 4 countries
United States6 sites, 6 recruiting
- Recruiting
Research Site
Fairfax, Virginia, 22031
- Recruiting
Research Site
Grand Rapids, Michigan, 49546
- Recruiting
Research Site
Houston, Texas, 77030
- Recruiting
Research Site
Pittsburgh, Pennsylvania, 15232
- Recruiting
Research Site
San Antonio, Texas, 78229
- Recruiting
Research Site
St Louis, Missouri, 63110
South Korea4 sites, 4 recruiting
- Recruiting
Research Site
Seoul, 03080
- Recruiting
Research Site
Seoul, 06351
- Recruiting
Research Site
Seoul, 3722
- Recruiting
Research Site
Seoul, 5505
Japan2 sites, 2 recruiting
- Recruiting
Research Site
Chūōku, 104-0045
- Recruiting
Research Site
Kashiwa, 227-8577
About this study
Official 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
A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
Read the 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
- Conditions
- Melanoma, Non-small Cell Lung Cancer, Squamous Cell Carcinoma (Skin), Renal Cell Carcinoma, Merkel Cell Carcinoma, Triple Negative Breast Cancer
- Being tested
- AZD6750, rilvegostomig
- Medical subject headings
- Melanoma, Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell, Carcinoma, Renal Cell, Carcinoma, Merkel Cell, Triple Negative Breast Neoplasms, Squamous Cell Carcinoma of Head and Neck, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6750Drug
AZD6750- CD8 guided IL-2
rilvegostomigDrug
Rilvegostomig- PD1-TIGIT bispecific antibody
| Study group | Role | What they receive |
|---|---|---|
| Module 1 | Experimental | AZD6750 administered intravenously (IV) as a single agent Receives: Drug: AZD6750 |
| Module 2 | Experimental | AZD6750 given in combination with rilvegostomig (IV) Receives: Drug: AZD6750; Drug: rilvegostomig |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety- Part 1A & Part 2A (dose escalation) and Part 2B (dose expansion)
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: Measured from the informed consent until Day 90 post-last dose.
Efficacy- Part 2B only (dose expansion)
To assess the preliminary anti-tumor activity of AZD6750 in combination with other anti-cancer agents.
Measured: 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 outcomes (9)
Pharmacodynamic- Part 1A & Part 2A (dose escalation) and Part B (dose expansion)
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: 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)
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: 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)
To assess the preliminary anti-tumor activity of AZD6750 alone and in combination with other anti-cancer agents.
Measured: 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)
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: 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)
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: 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)
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: 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)
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: 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)
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: 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)
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: Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start29 Jul 2025
- Primary completion2 Oct 2029 (estimated)
- Study completion2 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Module 1 consists of treatment with AZD6750 administered as a single agent to enroll participants with select locally advanced or metastatic solid tumors who have received prior adequate SoC. Select solid tumors include the tumor types known to show activity with ICIs (either as a single agent or in combination with other anti-cancer agents) or include reports potentially showing benefit of IL-2. Module 1 will consist of Part 1A (dose escalation). The combination arm (Module 2) will open on agreement with SRC, and will investigate AZD6750 and rilvegostomig, enrolling 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%. Module 2 will consist of an escalation arm (Module 2A) and an expansion arm (Module 2B). Dose expansion (Module 2B) may open further to characterize preliminary efficacy of AZD6750 in combination with rilvegostomig.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115043
- Sponsor's protocol ID
- D7350C00001
- Status last verified
- Oct 2026
- First submitted
- 16 Jul 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07115043
- Acronym / sponsor ID
- D7350C00001
- Conditions
- Melanoma, Non-small Cell Lung Cancer, Squamous Cell Carcinoma (Skin), Renal Cell Carcinoma, Merkel Cell Carcinoma, Triple Negative Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- 2 Oct 2029 (estimated)
- Study completion
- 2 Oct 2029 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Module 1 consists of treatment with AZD6750 administered as a single agent to enroll participants with select locally advanced or metastatic solid tumors who have received prior adequate SoC. Select solid tumors include the tumor types known to show activity with ICIs (either as a single agent or in combination with other anti-cancer agents) or include reports potentially showing benefit of IL-2. Module 1 will consist of Part 1A (dose escalation). The combination arm (Module 2) will open on agreement with SRC, and will investigate AZD6750 and rilvegostomig, enrolling 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%. Module 2 will consist of an escalation arm (Module 2A) and an expansion arm (Module 2B). Dose expansion (Module 2B) may open further to characterize preliminary efficacy of AZD6750 in combination with rilvegostomig.
| Arm | Type | Receives |
|---|---|---|
| Module 1 | Experimental | Drug: AZD6750AZD6750 administered intravenously (IV) as a single agent |
| Module 2 | Experimental | Drug: AZD6750, Drug: rilvegostomigAZD6750 given in combination with rilvegostomig (IV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD6750AZD6750- CD8 guided IL-2 | Drug | Module 1, Module 2 |
| rilvegostomigRilvegostomig- PD1-TIGIT bispecific antibody | Drug | Module 2 |
Primary outcome
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
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.
9 secondary outcomes
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)
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).
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)
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AZD6750 and rilvegostomig in people with Melanoma and Non-small Cell Lung Cancer, run by AstraZeneca at 13 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, South Korea, Japan, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.