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

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.

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.