Recruiting
Phase 1

Rilvegostomig

Sponsor:

AstraZeneca

Code:

NCT07161414

Conditions

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IV Rilvegostomig

Recombinant Human Hyaluronidase (rHu)

SC Rilvegostomig

SC rilvegostomig + rHu

Study Details

Brief summary:

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.

Conditions

Advanced Solid Tumors

Study ID

NCT07161414

Start date

Nov 25, 2025

Status verified date

Aug, 2026

Completion date

Jul 24, 2029

Anticipated

Primary completion date

Jul 19, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

experimental: Part 2 (dose confirmation): SC Rilvegostomig and rHu

Participants will receive SC rilvegostomig and rHu.

Interventions

IV Rilvegostomig

Rilvegostomig administered IV.

Recombinant Human Hyaluronidase (rHu)

rHu administered subcutaneously.

SC Rilvegostomig

Rilvegostomig administered subcutaneously.

SC rilvegostomig + rHu

SC rilvegostomig + rHu administered subcutaneously.

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Huntersville, North Carolina, United States, 28078

Research Site

Recruiting

San Antonio, Texas, United States, 78229

Research Site

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

AstraZeneca

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • 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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-09-01.