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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-25

Study Completion Date

2029-07-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Solid Tumors

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Recombinant Human Hyaluronidase Immunooncology monotherapy T cell Immunoglobulin and Immunoreceptor Tyrosine-based Inhibitory Motif Domain (TIGIT) Programmed Cell Death Protein 1 (PD-1) Bispecific immunotherapy Checkpoint inhibitor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part 1 (dose finding): Cohort A - SC Rilvegostomig Dose Level 1 (DL1) and rHu

Participants will receive IV rilvegostomig (Dose X) as their first dose of study treatment, followed by subsequent treatments with recombinant human hyaluronidase (rHu) and SC rilvegostomig (DL1) at predefined intervals.

Group Type EXPERIMENTAL

IV Rilvegostomig

Intervention Type DRUG

Rilvegostomig administered IV.

Recombinant Human Hyaluronidase (rHu)

Intervention Type DRUG

rHu administered subcutaneously.

SC Rilvegostomig

Intervention Type DRUG

Rilvegostomig administered subcutaneously.

Part 1 (dose finding): Cohort B - SC Rilvegostomig DL2 and rHu

Participants will receive IV rilvegostomig (Dose X) as their first dose of study treatment, followed by subsequent treatments with rHu and SC rilvegostomig (DL2) at predefined intervals.

Group Type EXPERIMENTAL

IV Rilvegostomig

Intervention Type DRUG

Rilvegostomig administered IV.

Recombinant Human Hyaluronidase (rHu)

Intervention Type DRUG

rHu administered subcutaneously.

SC Rilvegostomig

Intervention Type DRUG

Rilvegostomig administered subcutaneously.

Part 2 (dose confirmation): SC Rilvegostomig and rHu

Participants will receive SC rilvegostomig and rHu.

Group Type EXPERIMENTAL

SC rilvegostomig + rHu

Intervention Type DRUG

SC rilvegostomig + rHu administered subcutaneously.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IV Rilvegostomig

Rilvegostomig administered IV.

Intervention Type DRUG

Recombinant Human Hyaluronidase (rHu)

rHu administered subcutaneously.

Intervention Type DRUG

SC Rilvegostomig

Rilvegostomig administered subcutaneously.

Intervention Type DRUG

SC rilvegostomig + rHu

SC rilvegostomig + rHu administered subcutaneously.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

AZD2936 AZD2936

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Huntersville, North Carolina, United States

Site Status RECRUITING

Research Site

San Antonio, Texas, United States

Site Status RECRUITING

Research Site

Fairfax, Virginia, United States

Site Status RECRUITING