Study identifier:D702EC00001
ClinicalTrials.gov identifier:NCT07161414
EudraCT identifier:N/A
CTIS identifier:N/A
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)
Advanced Solid Tumors
Phase 1
No
IV Rilvegostomig, Recombinant Human Hyaluronidase (rHu), SC Rilvegostomig, SC rilvegostomig + rHu
All
40
Interventional
18 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Dec 2025 by AstraZeneca
AstraZeneca
PAREXEL
No locations available
| Arms | Assigned Interventions |
|---|---|
| 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 Name: AZD2936 Drug: Recombinant Human Hyaluronidase (rHu) rHu administered subcutaneously. Drug: SC Rilvegostomig Rilvegostomig administered subcutaneously. Other Name: 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 Name: AZD2936 Drug: Recombinant Human Hyaluronidase (rHu) rHu administered subcutaneously. Drug: SC Rilvegostomig Rilvegostomig administered subcutaneously. Other Name: 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. |