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Tests treatment safety and results for Advanced Solid Tumors
Official title 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
ClinicalTrials.gov ID: NCT07161414
What this study is testing
What is IV Rilvegostomig?
IV Rilvegostomig is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for advanced solid tumors.
Also referred to as AZD2936.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- Any severe or uncontrolled systemic diseases, which makes it undesirable for the participant to participate in the study or that would jeopardize...
- 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.
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Huntersville, North Carolina, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
- Seoul, South Korea
- Barcelona, Spain
- Madrid, Spain
- Newcastle upon Tyne, United Kingdom
- Sutton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntersville, North Carolina, United States; San Antonio, Texas, United States; Fairfax, Virginia, United States; Seoul, South Korea; Barcelona, Spain; Madrid, Spain and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.