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

Part of paid clinical trials in Huntersville, North Carolina.

Sponsor
AstraZeneca
Study ID
NCT07161414
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IV Rilvegostomig — DRUG
    Rilvegostomig administered IV.
  • Recombinant Human Hyaluronidase (rHu) — DRUG
    rHu administered subcutaneously.
  • SC Rilvegostomig — DRUG
    Rilvegostomig administered subcutaneously.
  • SC rilvegostomig + rHu — DRUG
    SC rilvegostomig + rHu administered subcutaneously.

Study Details

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.

Key Dates

Start date
Nov 25, 2025
Status verified
Jun 2026
Primary completion
Jul 19, 2027
Completion
Jul 24, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

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

Locations (3)

FacilityCityStateZIPSite coordinators
Research SiteHuntersvilleNorth Carolina28078-
Research SiteSan AntonioTexas78229-
Research SiteFairfaxVirginia22031-

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Research Site· Huntersville, NCResearch Site· San Antonio, TXResearch Site· Fairfax, VA

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