NCT07161414

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
38mo left

Started Nov 2025

Typical duration for phase_1

Geographic Reach
4 countries

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Nov 2025Jul 2029

First Submitted

Initial submission to the registry

September 3, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

November 25, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2029

Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

1.6 years

First QC Date

September 3, 2025

Last Update Submit

June 9, 2026

Conditions

Advanced Solid Tumors

Keywords

Recombinant Human HyaluronidaseImmunooncology monotherapyT cell Immunoglobulin and Immunoreceptor Tyrosine-based Inhibitory Motif Domain (TIGIT)Programmed Cell Death Protein 1 (PD-1)Bispecific immunotherapyCheckpoint inhibitor

Outcome Measures

Primary Outcomes (1)

  • Area under the Concentration-time Curve During One Dosing Interval (AUCtau)

    Bioavailability based on AUCtau at first SC dose will be determined.

    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 Outcomes (5)

  • Number of participants with adverse events (AEs)

    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)

    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)

    From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 29 months).

  • AUCtau

    From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 29 months).

  • Serum rilvegostomig concentration

    From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 29 months).

Study Arms (3)

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

EXPERIMENTAL

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.

Drug: IV RilvegostomigDrug: Recombinant Human Hyaluronidase (rHu)Drug: SC Rilvegostomig

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

EXPERIMENTAL

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.

Drug: IV RilvegostomigDrug: Recombinant Human Hyaluronidase (rHu)Drug: SC Rilvegostomig

Part 2 (dose confirmation): SC Rilvegostomig and rHu

EXPERIMENTAL

Participants will receive SC rilvegostomig and rHu.

Drug: SC rilvegostomig + rHu

Interventions

SC rilvegostomig + rHuDRUG

SC rilvegostomig + rHu administered subcutaneously.

Part 2 (dose confirmation): SC Rilvegostomig and rHu
IV RilvegostomigDRUG

Rilvegostomig administered IV.

Also known as: AZD2936
Part 1 (dose finding): Cohort A - SC Rilvegostomig Dose Level 1 (DL1) and rHuPart 1 (dose finding): Cohort B - SC Rilvegostomig DL2 and rHu
Recombinant Human Hyaluronidase (rHu)DRUG

rHu administered subcutaneously.

Part 1 (dose finding): Cohort A - SC Rilvegostomig Dose Level 1 (DL1) and rHuPart 1 (dose finding): Cohort B - SC Rilvegostomig DL2 and rHu
SC RilvegostomigDRUG

Rilvegostomig administered subcutaneously.

Also known as: AZD2936
Part 1 (dose finding): Cohort A - SC Rilvegostomig Dose Level 1 (DL1) and rHuPart 1 (dose finding): Cohort B - SC Rilvegostomig DL2 and rHu

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Research Site

Huntersville, North Carolina, 28078, United States

RECRUITING

Research Site

San Antonio, Texas, 78229, United States

RECRUITING

Research Site

Fairfax, Virginia, 22031, United States

RECRUITING

Research Site

Seoul, 03080, South Korea

RECRUITING

Research Site

Seoul, 03722, South Korea

RECRUITING

Research Site

Barcelona, 08035, Spain

NOT YET RECRUITING

Research Site

Barcelona, 08036, Spain

RECRUITING

Research Site

Madrid, 28027, Spain

RECRUITING

Research Site

Madrid, 28040, Spain

RECRUITING

Research Site

Newcastle upon Tyne, NE7 7DN, United Kingdom

SUSPENDED

Research Site

Sutton, SM2 5PT, United Kingdom

SUSPENDED

MeSH Terms

Conditions

Parkinson Disease 4, Autosomal Dominant Lewy Body

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2025

First Posted

September 8, 2025

Study Start

November 25, 2025

Primary Completion (Estimated)

July 19, 2027

Study Completion (Estimated)

July 24, 2029

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
More information

Locations

US(3)KR(2)ES(4)GB(2)