RecruitingPhase 1

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 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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests rilvegostomig given as a shot under the skin to find a dose that gives similar drug levels as a dose given into a vein. It also checks safety and how the body handles the drug. It is for adults with advanced solid tumors who have had standard cancer treatment and whose doctor thinks treatment with one immune-based cancer drug is suitable.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Tests of tissue or cells show a solid tumor that has spread or cannot be removed by surgery.
  • You have had standard cancer treatment, such as chemotherapy, immune-based treatment, or targeted treatment.
  • The study doctor thinks treatment with one immune-based drug is suitable and will likely allow you to stay through the drug-level testing period.
  • You are fully active or can do light work, and your ability to do daily activities is not getting worse.
  • You are expected to live at least 12 weeks.
  • Your organs and bone marrow, which makes blood cells, work well enough.
  • You weigh at least 30 kg (about 66 pounds).

Who can't join

  • You have a severe or uncontrolled illness that makes study participation unsafe or hard to follow, or serious or uncontrolled heart or blood vessel disease.
  • You have had an organ transplant or a stem cell transplant from another person, or another cancer was active in the past 2 years.
  • Side effects from past cancer treatment have not returned to mild levels or your usual level, except hair loss; past immune-based treatment caused side effects that made you stop it for good; or you had cancer treatment within 28 days before the first study dose.
  • You have unstable brain tumors that have spread and cause symptoms, pressure on the spinal cord, or a history of cancer in the lining around the brain and spinal cord.
  • You have an active disorder that weakens your immune system, an active infection such as TB, HIV, or hepatitis B or C, or another active or uncontrolled infection needing treatment throughout the body.
  • You have active lung inflammation, a serious long-term gut condition with diarrhea, or a skin disease not caused by infection that needs treatment throughout the body.
  • You have or have had an immune-system or inflammatory disorder needing long-term medicines that act throughout the body, such as steroids or drugs that weaken the immune system.
  • You have a known allergy to rilvegostomig, hyaluronidase, or any ingredient in the study products.

Simplified for readability. The official criteria below are what the study team uses.

Official 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: 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. 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 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. * 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.

Study sites (3)

NC

TX

VA