Advanced Solid TumorsPhase 1ARTEMIDE-subQNCT07161414
A Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Rilvegostomig in Adult Participants With Advanced Solid Tumors Previously Treated With Standard of Care Therapy
A Phase 1 study testing IV Rilvegostomig, Recombinant Human Hyaluronidase (rHu) and SC Rilvegostomig in people with Advanced Solid Tumors, run by AstraZeneca at 11 sites in 4 countries.
Trial summary
The purpose of this study is to determine the subcutaneous (SC) dose that gives rilvegostomig exposure comparable to the intravenous (IV) exposure, and to evaluate the pharmacokinetics (PK) and safety of SC rilvegostomig in adult participants with advanced solid tumors previously treated with standard of care therapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- IV Rilvegostomig, Recombinant Human Hyaluronidase (rHu) and SC Rilvegostomig
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 25 Nov 2025to 24 Jul 2029
- Phase
- Phase 1
- 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
- Histologically or cytologically documented advanced (metastatic and/or unresectable) solid tumor.
- Participants must have received prior anticancer treatment for the disease under study: this may include chemotherapy, immunotherapy, or targeted therapy as considered standard of care, where clinically appropriate.
- IO monotherapy considered clinically appropriate and reasonably likely to permit study participation through at least the PK-evaluable period, in the investigator's judgment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment with no deterioration.
- Minimum life expectancy of ≥ 12 weeks at enrollment.
- Adequate organ and marrow function.
- Body weight ≥ 30 kg.
Who cannot join
- Any severe or uncontrolled systemic diseases, which makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
- History of organ transplant or allogeneic stem cell transplant.
- History of another primary malignancy that was active within past 2 years.
- Persistent toxicities caused by previous anticancer treatment(s) excluding alopecia, not yet improved to Grade ≤ 1 or baseline.
- Unstable, symptomatic brain metastasis or spinal cord compression.
- History of leptomeningeal carcinomatosis.
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- Active primary immunodeficiency/active infectious disease including tuberculosis (TB), human immunodeficiency virus (HIV) infection or hepatitis B or C infection or any other active or uncontrolled infection requiring systemic treatment.
- Clinically significant or uncontrolled cardiovascular disease, including clinically significant arrhythmias, symptomatic heart failure, cardiomyopathy or myocarditis, recent myocardial infarction or unstable angina, or uncontrolled hypertension.
- Active or ongoing interstitial lung disease (ILD)/ pneumonitis, serious chronic gastrointestinal conditions associated with diarrhea; primary immunodeficiency, or non-infectious skin disease requiring systemic treatment.
- Active or prior documented autoimmune or inflammatory disorders requiring chronic systemic treatment with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs.
- Known allergy or hypersensitivity to rilvegostomig, hyaluronidase, or any excipients of the investigational products.
- Participants experienced a toxicity to prior immunotherapy that led to permanent discontinuation of prior immunotherapy.
- Prior anticancer treatment, including immunotherapy, up to 28 days prior to the first dose of study treatment.
Trial locations and contacts
11 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
11 sites in 4 countries
Spain4 sites, 4 recruiting
- Not yet recruiting
Research Site
Barcelona, 08035
- Recruiting
Research Site
Barcelona, 08036
- Recruiting
Research Site
Madrid, 28027
- Recruiting
Research Site
Madrid, 28040
United States3 sites, 3 recruiting
- Recruiting
Research Site
Fairfax, Virginia, 22031
- Recruiting
Research Site
Huntersville, North Carolina, 28078
- Recruiting
Research Site
San Antonio, Texas, 78229
South Korea2 sites, 2 recruiting
- Recruiting
Research Site
Seoul, 03080
- Recruiting
Research Site
Seoul, 03722
United Kingdom2 sites
- Withdrawn
Research Site
Newcastle upon Tyne, NE7 7DN
- Withdrawn
Research Site
Sutton, SM2 5PT
About this study
Official title: A Phase I, Multicenter, Dose Finding and Dose Confirmation Study to Investigate the Pharmacokinetics, and Safety of Subcutaneous Rilvegostomig in Adult Participants With Advanced Solid Tumors Previously Treated With Standard of Care Therapy (ARTEMIDE-subQ)
The purpose of this study is to determine the subcutaneous (SC) dose that gives rilvegostomig exposure comparable to the intravenous (IV) exposure, and to evaluate the pharmacokinetics (PK) and safety of SC rilvegostomig in adult participants with advanced solid tumors previously treated with standard of care therapy for whom immunooncology (IO) monotherapy would be deemed appropriate by the investigator.
Read the detailed description
This is a Phase I, open-label, multicenter, multi-part, dose finding and dose confirmation study to evaluate the PK and safety of SC rilvegostomig.
The study includes 2 parts: Part 1 (Dose Finding) and Part 2 (Dose Confirmation).
Part 1 will determine a SC rilvegostomig dose co-administered with rHu that yields drug exposure comparable with IV rilvegostomig. It will include 2 planned dose levels (DL1 in Cohort A and DL2 in Cohort B). Additional dose levels may be added, if needed.
Part 2 will be initiated once a dose has been identified based on Part 1. This part will evaluate the bioavailability, safety, and tolerability of SC rilvegostomig + rHu.
- Conditions
- Advanced Solid Tumors
- Being tested
- IV Rilvegostomig, Recombinant Human Hyaluronidase (rHu), SC Rilvegostomig, SC rilvegostomig + rHu
- Keywords
- Recombinant Human Hyaluronidase, Immunooncology monotherapy, T cell Immunoglobulin and Immunoreceptor Tyrosine-based Inhibitory Motif Domain (TIGIT), Programmed Cell Death Protein 1 (PD-1), Bispecific immunotherapy, Checkpoint inhibitor
- Medical subject headings
- Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV RilvegostomigDrug
Also called AZD2936
Rilvegostomig administered IV.
Recombinant Human Hyaluronidase (rHu)Drug
rHu administered subcutaneously.
SC RilvegostomigDrug
Also called AZD2936
Rilvegostomig administered subcutaneously.
SC rilvegostomig + rHuDrug
SC rilvegostomig + rHu administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (dose finding): Cohort A - SC Rilvegostomig Dose Level 1 (DL1) and rHu | Experimental | Participants will receive IV rilvegostomig (Dose X) as their first dose of study treatment, followed by subsequent treatments with recombinant human hyaluronidase (rHu) and SC rilvegostomig (DL1) at predefined intervals. Receives: Drug: IV Rilvegostomig; Drug: Recombinant Human Hyaluronidase (rHu); Drug: SC Rilvegostomig |
| Part 1 (dose finding): Cohort B - SC Rilvegostomig DL2 and rHu | Experimental | Participants will receive IV rilvegostomig (Dose X) as their first dose of study treatment, followed by subsequent treatments with rHu and SC rilvegostomig (DL2) at predefined intervals. Receives: Drug: IV Rilvegostomig; Drug: Recombinant Human Hyaluronidase (rHu); Drug: SC Rilvegostomig |
| Part 2 (dose confirmation): SC Rilvegostomig and rHu | Experimental | Participants will receive SC rilvegostomig and rHu. Receives: Drug: SC rilvegostomig + rHu |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the Concentration-time Curve During One Dosing Interval (AUCtau)
Bioavailability based on AUCtau at first SC dose will be determined.
Measured: From Day 1 up to end of Cycle 2 in Part 1 and end of Cycle 1 in Part 2 (each cycle will be of 3 weeks)
Secondary outcomes (5)
Number of participants with adverse events (AEs)
To assess safety and tolerability of SC rilvegostomig. Safety and tolerability will be evaluated in terms of AEs (graded by CTCAE version 5.0), clinical laboratory assessments, vital signs, physical examinations, and ECOG performance status.
Measured: From Day 1 up to 90 days post last dose (Up to approximately 23 months)
Observed Lowest Concentration before the Next Dose is Administered (Ctrough)
To assess drug exposure (Ctrough) of SC rilvegostomig comparable to that of IV rilvegostomig.
Measured: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 23 months).
Average drug concentration over a dosing interval (Cavg)
To assess drug exposure (Cavg) of SC rilvegostomig comparable to that of IV rilvegostomig.
Measured: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 23 months).
AUCtau
To assess drug exposure of SC rilvegostomig comparable to that of IV rilvegostomig.
Measured: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 23 months).
Serum rilvegostomig concentration
To assess drug exposure (serum concentration) of SC rilvegostomig comparable to that of IV rilvegostomig.
Measured: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 23 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start25 Nov 2025
- Primary completion19 Jul 2027 (estimated)
- Study completion24 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161414
- Sponsor's protocol ID
- D702EC00001
- Other IDs
- 2025-521614-26-00, 2025
- Acronym
- ARTEMIDE-subQ
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Dose Finding and Dose Confirmation Study to Investigate the Pharmacokinetics, and Safety of Subcutaneous Rilvegostomig in Adult Participants With Advanced Solid Tumors Previously Treated With Standard of Care Therapy (ARTEMIDE-subQ)
- ClinicalTrials.gov ID
- NCT07161414
- Acronym / sponsor ID
- ARTEMIDE-subQ / D702EC00001
- Conditions
- Advanced Solid Tumors
- Keywords
- Recombinant Human Hyaluronidase, Immunooncology monotherapy, T cell Immunoglobulin and Immunoreceptor Tyrosine-based Inhibitory Motif Domain (TIGIT), Programmed Cell Death Protein 1 (PD-1), Bispecific immunotherapy, Checkpoint inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 19 Jul 2027 (estimated)
- Study completion
- 24 Jul 2029 (estimated)
- First posted
- 8 Sep 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.
The purpose of this study is to determine the subcutaneous (SC) dose that gives rilvegostomig exposure comparable to the intravenous (IV) exposure, and to evaluate the pharmacokinetics (PK) and safety of SC rilvegostomig in adult participants with advanced solid tumors previously treated with standard of care therapy for whom immunooncology (IO) monotherapy would be deemed appropriate by the investigator.
Detailed description
This is a Phase I, open-label, multicenter, multi-part, dose finding and dose confirmation study to evaluate the PK and safety of SC rilvegostomig.
The study includes 2 parts: Part 1 (Dose Finding) and Part 2 (Dose Confirmation).
Part 1 will determine a SC rilvegostomig dose co-administered with rHu that yields drug exposure comparable with IV rilvegostomig. It will include 2 planned dose levels (DL1 in Cohort A and DL2 in Cohort B). Additional dose levels may be added, if needed.
Part 2 will be initiated once a dose has been identified based on Part 1. This part will evaluate the bioavailability, safety, and tolerability of SC rilvegostomig + rHu.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 (dose finding): Cohort A - SC Rilvegostomig Dose Level 1 (DL1) and rHu | Experimental | Drug: IV Rilvegostomig, Drug: Recombinant Human Hyaluronidase (rHu), Drug: SC RilvegostomigParticipants will receive IV rilvegostomig (Dose X) as their first dose of study treatment, followed by subsequent treatments with recombinant human hyaluronidase (rHu) and SC rilvegostomig (DL1) at predefined intervals. |
| Part 1 (dose finding): Cohort B - SC Rilvegostomig DL2 and rHu | Experimental | Drug: IV Rilvegostomig, Drug: Recombinant Human Hyaluronidase (rHu), Drug: SC RilvegostomigParticipants will receive IV rilvegostomig (Dose X) as their first dose of study treatment, followed by subsequent treatments with rHu and SC rilvegostomig (DL2) at predefined intervals. |
| Part 2 (dose confirmation): SC Rilvegostomig and rHu | Experimental | Drug: SC rilvegostomig + rHuParticipants will receive SC rilvegostomig and rHu. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically documented advanced (metastatic and/or unresectable) solid tumor.
- Participants must have received prior anticancer treatment for the disease under study: this may include chemotherapy, immunotherapy, or targeted therapy as considered standard of care, where clinically appropriate.
- IO monotherapy considered clinically appropriate and reasonably likely to permit study participation through at least the PK-evaluable period, in the investigator's judgment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment with no deterioration.
- Minimum life expectancy of ≥ 12 weeks at enrollment.
Key exclusion criteria (13 listed)
- Any severe or uncontrolled systemic diseases, which makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
- History of organ transplant or allogeneic stem cell transplant.
- History of another primary malignancy that was active within past 2 years.
- Persistent toxicities caused by previous anticancer treatment(s) excluding alopecia, not yet improved to Grade ≤ 1 or baseline.
- Unstable, symptomatic brain metastasis or spinal cord compression.
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 |
|---|---|---|
| IV RilvegostomigAlso: AZD2936Rilvegostomig administered IV. | Drug | Part 1 (dose finding): Cohort A - SC Rilvegostomig Dose Level 1 (DL1) and rHu, Part 1 (dose finding): Cohort B - SC Rilvegostomig DL2 and rHu |
| Recombinant Human Hyaluronidase (rHu)rHu administered subcutaneously. | Drug | Part 1 (dose finding): Cohort A - SC Rilvegostomig Dose Level 1 (DL1) and rHu, Part 1 (dose finding): Cohort B - SC Rilvegostomig DL2 and rHu |
| SC RilvegostomigAlso: AZD2936Rilvegostomig administered subcutaneously. | Drug | Part 1 (dose finding): Cohort A - SC Rilvegostomig Dose Level 1 (DL1) and rHu, Part 1 (dose finding): Cohort B - SC Rilvegostomig DL2 and rHu |
| SC rilvegostomig + rHuSC rilvegostomig + rHu administered subcutaneously. | Drug | Part 2 (dose confirmation): SC Rilvegostomig and rHu |
Primary outcome
Area under the Concentration-time Curve During One Dosing Interval (AUCtau)
Time frame: From Day 1 up to end of Cycle 2 in Part 1 and end of Cycle 1 in Part 2 (each cycle will be of 3 weeks)
Bioavailability based on AUCtau at first SC dose will be determined.
5 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: From Day 1 up to 90 days post last dose (Up to approximately 23 months)
Observed Lowest Concentration before the Next Dose is Administered (Ctrough)
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 23 months).
Average drug concentration over a dosing interval (Cavg)
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 23 months).
AUCtau
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 23 months).
Serum rilvegostomig concentration
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 23 months).
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 5 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
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IV Rilvegostomig, Recombinant Human Hyaluronidase (rHu) and SC Rilvegostomig in people with Advanced Solid Tumors, run by AstraZeneca at 11 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 7 inclusion and 13 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 5 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 11 sites in Spain, United States, South Korea, United Kingdom. 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 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.
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?
Area under the Concentration-time Curve During One Dosing Interval (AUCtau) (time frame: From Day 1 up to end of Cycle 2 in Part 1 and end of Cycle 1 in Part 2 (each cycle will be of 3 weeks)). 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 5 Oct 2026.