Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: IV Rilvegostomig
    Rilvegostomig administered IV.
    Other names:
    • AZD2936
  • Drug: Recombinant Human Hyaluronidase (rHu)
    rHu administered subcutaneously.
  • Drug: SC Rilvegostomig
    Rilvegostomig administered subcutaneously.
    Other names:
    • AZD2936
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.
  • Drug: IV Rilvegostomig
    Rilvegostomig administered IV.
    Other names:
    • AZD2936
  • Drug: Recombinant Human Hyaluronidase (rHu)
    rHu administered subcutaneously.
  • Drug: SC Rilvegostomig
    Rilvegostomig administered subcutaneously.
    Other names:
    • AZD2936
Experimental
Part 2 (dose confirmation): SC Rilvegostomig and rHu 		Participants will receive SC rilvegostomig and rHu.
  • Drug: SC rilvegostomig + rHu
    SC rilvegostomig + rHu administered subcutaneously.

Recruiting Locations

Research Site
Huntersville 4472370, North Carolina 4482348 28078

Research Site
San Antonio 4726206, Texas 4736286 78229

Research Site
Fairfax 4758023, Virginia 6254928 22031

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.