A Phase I, Multicenter, Dose Finding and Dose Confirmation Study to Investigate the Pharmacokinetics, and Safety of Subcutaneous Rilvegostomig in Adult Participants With Advanced Solid Tumors Previously Treated With Standard of Care Therapy (ARTEMIDE-subQ)
Study Identifier:
D702EC00001
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
Study Contact Information:
Recruiting
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Study 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.
To Investigate the Pharmacokinetics and Safety of Subcutaneous Rilvegostomig in Adult Participants with Advanced Solid Tumors Previously Treated with Standard of Care Therapy
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Solid Tumor
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Part 1 (dose finding): Cohort A - SC Rilvegostomig Dose Level 1 (DL1) and rHu
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Drug: 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: Drug: IV Rilvegostomig
Drug: Rilvegostomig administered IV.
Drug: Other Names: AZD2936
Drug: Drug: Recombinant Human Hyaluronidase (rHu)
Drug: rHu administered subcutaneously.
Drug: Drug: SC Rilvegostomig
Drug: Rilvegostomig administered subcutaneously.
Drug: EXPERIMENTAL: Part 1 (dose finding): Cohort B - SC Rilvegostomig DL2 and rHu
Drug: 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: EXPERIMENTAL: Part 2 (dose confirmation): SC Rilvegostomig and rHu
Drug: Participants will receive SC rilvegostomig and rHu.
Drug: Drug: SC rilvegostomig + rHu
Drug: SC rilvegostomig + rHu administered subcutaneously.
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
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.
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (FJD)
Madrid, Spain, 28040
Investigator
Victor Moreno Garcia
Status
Recruiting
Condition(s) Treated at Site
Solid Tumor