Rilvegostomig for Cancer

(ARTEMIDE-subQ Trial)

Recruiting at 7 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must be taking: Immunotherapy

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: Organ transplant, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks to determine the appropriate dose of a new cancer treatment, rilvegostomig, when administered under the skin. It aims to assess whether this method is as effective as intravenous administration and to evaluate its safety for individuals with advanced solid tumors. Participants should have previously tried other cancer treatments and be deemed suitable for single-drug immunotherapy by their doctor. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you must not have had any anticancer treatment, including immunotherapy, in the 28 days before starting the study treatment.

Is there any evidence suggesting that rilvegostomig is likely to be safe for humans?

Research has shown that rilvegostomig is generally safe. Studies with patients who have non-small cell lung cancer (NSCLC) found it to be well-tolerated, regardless of their levels of a protein called PD-L1. Another study demonstrated that combining rilvegostomig with chemotherapy was also safe.

Overall, these findings suggest that rilvegostomig is usually well-tolerated. Since this study is in an early phase, it focuses on understanding the safety and how the treatment moves through the body. While earlier studies provide a positive view on safety, this trial will help confirm the safety of rilvegostomig when administered in different ways. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Rilvegostomig is unique because it combines with recombinant human hyaluronidase (rHu) to enhance its delivery, potentially improving how the drug spreads in the body. This combination could lead to more effective targeting of cancer cells compared to standard treatments like chemotherapy, which often affect both healthy and cancerous cells. Furthermore, the ability to administer rilvegostomig both intravenously and subcutaneously offers flexibility in treatment, potentially improving patient comfort and adherence. Researchers are excited about its potential to provide a more precise and patient-friendly option for cancer treatment.

What evidence suggests that rilvegostomig might be an effective treatment for cancer?

Research has shown that rilvegostomig has potential in treating certain cancers. One study revealed that 73.5% of patients with advanced bladder cancer did not experience cancer progression after 12 months. Another study found rilvegostomig effective for patients with advanced lung cancer, particularly those who hadn't received checkpoint inhibitors. For these patients, rilvegostomig was generally well tolerated with few serious side effects. Additionally, when combined with chemotherapy, 73.0% of patients did not see their cancer worsen after six months. These findings suggest that rilvegostomig could be a promising option for treating advanced cancers. Participants in this trial will receive rilvegostomig in different dosing regimens to further evaluate its effectiveness and safety. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that have spread or can't be removed by surgery, who've already tried standard treatments. It's suitable if the doctor thinks a single immunotherapy would be right and if patients are fairly active (can take care of themselves), expected to live at least 12 weeks, weigh over 30 kg, and have good organ/marrow function.

Inclusion Criteria

My doctor thinks a single immunotherapy is right for me.

My cancer is advanced, cannot be removed by surgery, and has spread.

Minimum life expectancy of ≥ 12 weeks at enrollment

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

I still have side effects from cancer treatment, except for hair loss.

I do not have any ongoing serious illnesses or infections.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Finding

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).

Up to 29 months

Dose Confirmation

Part 2 will evaluate the bioavailability, safety, and tolerability of SC rilvegostomig + rHu.

Up to 29 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days post last dose

What Are the Treatments Tested in This Trial?

Interventions

• Rilvegostomig

Trial Overview

The study is testing Rilvegostomig given under the skin (SC) versus into a vein (IV) in people with Parkinson's disease or solid tumors. It aims to find the SC dose equal to IV exposure and assess how the body processes it plus safety. Some will also get an enzyme called rHu to help absorption.

How Is the Trial Designed?

Group I: Part 2 (dose confirmation): SC Rilvegostomig and rHu Experimental Treatment 1 Intervention

Participants will receive SC rilvegostomig and rHu.

Group II: Part 1 (dose finding): Cohort B - SC Rilvegostomig DL2 and rHu Experimental Treatment 3 Interventions

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.

Group III: Part 1 (dose finding): Cohort A - SC Rilvegostomig Dose Level 1 (DL1) and rHu Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Citations

1.

daiichisankyo.us

daiichisankyo.us/press-releases/-/article/datroway-plus-rilvegostomig-showed-promising-tumor-responses-in-patients-with-metastatic-urothelial-cancer-in-tropion-pantumor03-phase-2-trial

DATROWAY Plus Rilvegostomig Showed Promising Tumor ...

Median progression free survival (PFS) was not reached in the first-line setting and the PFS rate was 73.5% (95% CI: 46.5-88.4) at 12 months. As ...

2.

oncodaily.com

oncodaily.com/oncolibrary/artemide-01-trial

ARTEMIDE-01 Trial Demonstrates Promising Efficacy and ...

Rilvegostomig demonstrated promising efficacy and manageable safety in CPI-naïve metastatic NSCLC, particularly among patients with high PD-L1 ...

3.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.4080

First-line rilvegostomig (rilve) plus chemotherapy (CTx) in ...

Efficacy and safety data are shown in the Table. The 6-month PFS rate was 73.0%; median PFS was 8.3 months. Median PFS was numerically ...

4.

lungcancerstoday.com

lungcancerstoday.com/post/rilvegostomig-appears-safe-effective-for-cpi-naive-metastatic-nsclc

Rilvegostomig Appears Safe and Effective for CPI-naïve ...

The findings showed that rilvegostomig was well tolerated; it also presented few treatment-related discontinuations (4.2%) and grade ≥3 ...

5.

targetedonc.com

targetedonc.com/view/dato-dxd-rilvegostomig-shows-potent-activity-in-1l-2l-urothelial-cancer

Dato-DXd/Rilvegostomig Shows Potent Activity in 1L/2L ...

In the second-line cohort (n = 18), the confirmed ORR was 38.9% (95% CI, 17.3%-64.3%), and the 12-week DCR was 83.3% (95% CI, 66.6%-93.7%). The ...

6.

jto.org

jto.org/article/S1556-0864(24)00935-3/fulltext

OA11.03 Efficacy and Safety of Rilvegostomig, an Anti-PD ...

In CPI-naïve patients, rilvegostomig showed a favourable safety profile and encouraging preliminary efficacy in those with PD-L1 TPS 1‒49% and PD-L1 TPS ≥50%.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06692738

NCT06692738 | A Global Phase III Study of Rilvegostomig ...

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab.