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

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)

Overview

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 will 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.

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 outcome measures

• 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)]

Secondary outcome measures (5)

• Number of participants with adverse events (AEs) [Time frame: 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) [Time frame: 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) [Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 29 months).]
• AUCtau [Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 29 months).]
• Serum rilvegostomig concentration [Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 29 months).]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 4 centers

• Research Site — Barcelona
• Research Site — Barcelona
• Research Site — Madrid
• Research Site — Madrid

United States · 3 centers

• Research Site — Huntersville
• Research Site — San Antonio
• Research Site — Fairfax

South Korea · 2 centers

• Research Site — Seoul
• Research Site — Seoul

United Kingdom · 2 centers

• Research Site — Newcastle upon Tyne
• Research Site — Sutton

Identifiers

NCT: NCT07161414 · D702EC00001 · 2025-521614-26-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗