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)
New subcutaneous cancer drug trial for advanced solid tumors
Plain English Summary
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 is a Phase 1 clinical trial sponsored by AstraZeneca studying Advanced Solid Tumors. This trial tests a new way to give the cancer drug rilvegostomig under the skin (subcutaneously) to see if it works as well as the current IV method. It is for adults with advanced solid tumors that have not responded to standard treatments and who are suitable for immunotherapy. Participants will receive either the new subcutaneous drug or the standard IV drug, and will be closely monitored for safety and drug levels. Alternatives include continuing standard treatments, other cancer therapies, or palliative care, depending on the patient's situation. The trial aims to enroll 40 participants.
Official 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 for whom immunooncology (IO) monotherapy would be deemed appropriate by the investigator.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults (18+) with advanced solid tumors that have spread or cannot be removed. Patients must have received prior cancer treatment and be suitable for immunotherapy. Participants should have a good general health status (ECOG 0 or 1) and a life expectancy of at least 12 weeks. Individuals with unstable brain metastases, active infections, recent heart problems, or certain autoimmune conditions may not be eligible. This trial is studying Advanced Solid Tumors, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how much drug gets into the bloodstream over a specific period, ensuring the new under-the-skin method delivers a comparable amount of medication to the body as the curren The specific primary outcome measures are: Area under the Concentration-time Curve During One Dosing Interval (AUCtau) (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)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.
Why This Trial Matters
This trial aims to find a more convenient way to administer rilvegostomig, potentially improving patient experience by offering a subcutaneous injection instead of an intravenous infusion for advanced This research targets Advanced Solid Tumors, where improved treatment options are needed.
Investor Insight
This Phase 1 trial for a subcutaneous formulation of rilvegostomig signals AstraZeneca's effort to optimize drug delivery for advanced solid tumors, potentially expanding market access and patient con Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if this trial is a good fit for your specific cancer and treatment history. Understand that you will receive either the standard IV infusion or the new subcutaneous injection, and will have frequent blood draws and check-ups. Be prepared for regular visits to the research site for drug administration and monitoring. This trial is currently recruiting participants. The trial is being conducted at 11 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: SEQUENTIAL
- Masking: NONE
- Enrollment: 40 participants
Interventions
- DRUG: IV Rilvegostomig — Rilvegostomig administered IV.
- DRUG: Recombinant Human Hyaluronidase (rHu) — rHu administered subcutaneously.
- DRUG: SC Rilvegostomig — Rilvegostomig administered subcutaneously.
- DRUG: SC rilvegostomig + rHu — SC rilvegostomig + rHu administered subcutaneously.
Primary Outcomes
- Area under the Concentration-time Curve During One Dosing Interval (AUCtau) (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
- Number of participants with adverse events (AEs) (From Day 1 up to 90 days post last dose (Up to approximately 29 months))
- Observed Lowest Concentration before the Next Dose is Administered (Ctrough) (From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 29 months).)
- Average drug concentration over a dosing interval (Cavg) (From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 29 months).)
- AUCtau (From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 29 months).)
- Serum rilvegostomig concentration (From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 29 months).)
Full Eligibility Criteria
Inclusion Criteria: * Histologically or cytologically documented advanced (metastatic and/or unresectable) solid tumor. * Participants must have received prior anticancer treatment for the disease under study. * IO monotherapy deemed appropriate by the investigator. * 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. Exclusion Criteria: * 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. * 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. * Active primary immunodeficiency/active infectious disease including tuberculosis (TB), human immunodeficiency virus (HIV) infection or hepatitis A, B or C infection. * History of clinically significant arrhythmia, cardiomyopathy of any etiology; symptomatic congestive heart failure, history of myocardial infarction within the past 6 months. * Uncontrolled intercurrent illness including but not limited to ongoing or active known infection; interstitial lung disease (ILD), serious chronic gastrointestinal conditions associated with diarrhea; active non-infectious skin disease requiring systemic treatment. * Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment. * 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
- Research Site, Huntersville, North Carolina, United States
- Research Site, San Antonio, Texas, United States
- Research Site, Fairfax, Virginia, United States
- Research Site, Seoul, South Korea
- Research Site, Seoul, South Korea
- Research Site, Barcelona, Spain
- Research Site, Barcelona, Spain
- Research Site, Madrid, Spain
- Research Site, Madrid, Spain
- Research Site, Newcastle upon Tyne, United Kingdom
- ...and 1 more locations
Frequently Asked Questions
What is clinical trial NCT07161414?
NCT07161414 is a Phase 1 INTERVENTIONAL study titled "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." It is currently recruiting and is sponsored by AstraZeneca. The trial targets enrollment of 40 participants.
What conditions does NCT07161414 study?
This trial investigates treatments for Advanced Solid Tumors. The primary condition under study is Advanced Solid Tumors.
What treatments are being tested in NCT07161414?
The interventions being studied include: IV Rilvegostomig (DRUG), Recombinant Human Hyaluronidase (rHu) (DRUG), SC Rilvegostomig (DRUG), SC rilvegostomig + rHu (DRUG). Rilvegostomig administered IV.
What does Phase 1 mean for NCT07161414?
Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.
What is the current status of NCT07161414?
This trial is currently "Recruiting." It started on 2025-11-25. The estimated completion date is 2029-07-24.
Who is sponsoring NCT07161414?
NCT07161414 is sponsored by AstraZeneca. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07161414?
The trial aims to enroll 40 participants. The trial is currently recruiting and accepting new participants.
How is NCT07161414 designed?
This is a interventional study, uses randomized allocation, follows a sequential design, employs none masking.
What are the primary outcomes being measured in NCT07161414?
The primary outcome measures are: Area under the Concentration-time Curve During One Dosing Interval (AUCtau) (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)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07161414 being conducted?
This trial is being conducted at 11 sites, including Huntersville, North Carolina; San Antonio, Texas; Fairfax, Virginia; Seoul and 7 more sites (United States, South Korea, Spain).
Where can I find official information about NCT07161414?
The official record for NCT07161414 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07161414. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07161414 testing in simple terms?
This trial tests a new way to give the cancer drug rilvegostomig under the skin (subcutaneously) to see if it works as well as the current IV method. It is for adults with advanced solid tumors that have not responded to standard treatments and who are suitable for immunotherapy.
Why is this trial significant?
This trial aims to find a more convenient way to administer rilvegostomig, potentially improving patient experience by offering a subcutaneous injection instead of an intravenous infusion for advanced
What are the potential risks of participating in NCT07161414?
Common side effects may include injection site reactions (redness, swelling, pain) for the subcutaneous form. As with any cancer treatment, there's a risk of general side effects like fatigue, nausea, or changes in blood counts. Specific risks related to rilvegostomig, such as immune-related side effects, will be closely monitored. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07161414?
Ask your doctor if this trial is a good fit for your specific cancer and treatment history. Understand that you will receive either the standard IV infusion or the new subcutaneous injection, and will have frequent blood draws and check-ups. Be prepared for regular visits to the research site for drug administration and monitoring. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07161414 signal from an investment perspective?
This Phase 1 trial for a subcutaneous formulation of rilvegostomig signals AstraZeneca's effort to optimize drug delivery for advanced solid tumors, potentially expanding market access and patient con This is a Phase 1 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will receive either the new subcutaneous drug or the standard IV drug, and will be closely monitored for safety and drug levels. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.