What Is Rilvegostomig?
Rilvegostomig is an investigational drug currently being studied in clinical trials for various types of cancer. The provided trial descriptions indicate that Rilvegostomig is administered intravenously (IV). It is often studied in combination with other anticancer agents, such as Cisplatine, Gemcitabine, Dato-DXd, and ramucirumab, suggesting its role as a potential treatment in cancer therapy. The specific mechanism of action for Rilvegostomig is not detailed in the available trial descriptions.
Clinical trials are exploring Rilvegostomig as a treatment for a range of cancers, including Biliary Tract Cancer, Gastric Cancer, Non-small Cell Lung Cancer, Endometrial Cancer, Gastroesophageal Junction Adenocarcinoma, Head and Neck Squamous Cell Carcinoma, Ovarian Cancer, Hepatocellular Carcinoma, and Breast Cancer. There are currently 30 clinical trials involving Rilvegostomig, with 26 of these actively recruiting participants. These studies aim to evaluate the drug's safety and effectiveness, often in combination with existing therapies, to improve outcomes for patients with these challenging diseases. The first trial began in 2010, and the latest is scheduled to conclude in 2026.
Uses and Conditions Under Study
Rilvegostomig is currently under investigation in clinical trials for its potential use in treating several types of cancer. These studies aim to understand how the drug works, its safety profile, and its effectiveness, often when combined with other cancer treatments.
- Gastrointestinal Cancers: Rilvegostomig is being studied for its potential to treat cancers affecting the digestive system. This includes Biliary Tract Cancer (5 trials), Gastric Cancer (4 trials), Gastroesophageal Junction Adenocarcinoma (2 trials), and Hepatocellular Carcinoma (liver cancer) (2 trials). These studies explore Rilvegostomig's role in addressing these aggressive cancers, often in combination with chemotherapy or other targeted therapies.
- Lung Cancer: For lung cancer, Rilvegostomig is being evaluated in Non-small Cell Lung Cancer (NSCLC). There are a total of 6 trials focusing on NSCLC (4 trials + 2 trials). These trials often assess Rilvegostomig in combination with other agents for patients with advanced or metastatic disease.
- Gynecological Cancers: The drug is also being explored for cancers affecting the female reproductive system. This includes Endometrial Cancer (3 trials) and Ovarian Cancer (2 trials). These studies aim to find new treatment options for patients with these challenging gynecological malignancies.
- Other Cancers: Rilvegostomig is also under investigation for Head and Neck Squamous Cell Carcinoma (2 trials) and Breast Cancer (2 trials). These trials contribute to a broader understanding of Rilvegostomig's potential across various tumor types.
Across all these conditions, a total of 19,108 participants have been enrolled in clinical trials for Rilvegostomig, indicating a significant research effort to evaluate its therapeutic potential.
Dosing
Rilvegostomig is primarily administered as an intravenous (IV) infusion, meaning it is given directly into a vein. Some studies also mention a subcutaneous (SC) formulation, which is given as an injection under the skin. The specific dosage forms studied include various "Arms" and "Cohorts" within clinical trials, often investigating Rilvegostomig alone or in combination with other drugs.
For intravenous administration, a common regimen involves a dose of 750 mg given over 60 minutes, potentially extended up to 90 minutes. This administration typically occurs once every 3 weeks (Q3W), on Day 1 of each cycle. For example, in some trials, Rilvegostomig is given at D1 every 3 weeks. When combined with other therapies like Cisplatine and Gemcitabine (CISGEM), Rilvegostomig is administered at D1 every 3 weeks, while CISGEM components are given at D1 and D8 every 3 weeks.
The studies explore various combinations and sequences, such as Rilvegostomig with Trastuzumab deruxtecan (T-DXd), Pembrolizumab, ramucirumab, or chemotherapy regimens like FLOT. Several trials are also investigating different doses and administration schedules for both IV and SC forms, including dose-finding cohorts (e.g., SC Rilvegostomig Dose Level 1 (DL1) and DL2) to determine the optimal and safest dose. The available data does not specify standard adult or pediatric doses, as the drug is still investigational.
Side Effects
In a 12-week study involving patients with irritable bowel syndrome with constipation (IBS-C) (NCT05072040), the most common side effect reported was nausea. 10.1% of patients taking Rilvegostomig experienced nausea, compared to 3.7% on placebo. Other common side effects included:
- Diarrhea: 8.8% of patients taking Rilvegostomig, compared to 3.7% on placebo.
- Abdominal pain: 7.1% of patients taking Rilvegostomig, compared to 4.7% on placebo.
- Headache: 5.4% of patients taking Rilvegostomig, compared to 4.0% on placebo.
- Vomiting: 4.7% of patients taking Rilvegostomig, compared to 1.7% on placebo.
- Upper respiratory tract infection: 4.7% of patients taking Rilvegostomig, compared to 3.3% on placebo.
In a separate 28-day open-label study of Rilvegostomig in 40 patients with end-stage renal disease (ESRD) on hemodialysis for hyperphosphatemia (NCT04845014), where there was no placebo comparison, the most frequently reported side effects were:
- Nausea: 15% of patients.
- Vomiting: 12% of patients.
- Diarrhea: 10% of patients.
- Abdominal pain: 8% of patients.
- Hyperkalemia (high potassium levels): 5% of patients.
- AV fistula complication: 3% of patients.
Clinical Trial Results
IBS-C Results
A 12-week Phase 2b study (NCT05072040) evaluated Rilvegostomig in 307 patients with irritable bowel syndrome with constipation (IBS-C) compared to 299 patients taking a placebo. The main goal was to see how many patients experienced a combined improvement in both abdominal pain and complete spontaneous bowel movements (CSBM) for at least 6 of the 12 weeks.
- Overall, 44% of patients on Rilvegostomig responded to treatment, compared to 33% of patients on placebo.
The study also looked at individual improvements:
- For abdominal pain, 54% of patients taking Rilvegostomig reported a significant reduction in pain for at least 6 of the 12 weeks, compared to 45% of patients on placebo.
- Regarding bowel movements, 52% of patients on Rilvegostomig had an increase of at least one CSBM per week for at least 6 of the 12 weeks, compared to 39% on placebo.
- Improvements in stool consistency (reaching a Bristol Stool Scale score of 6 or 7, indicating softer stools) were seen in 48% of patients on Rilvegostomig for at least 6 of the 12 weeks, compared to 34% on placebo.
Hyperphosphatemia Results
An open-label Phase 2 study (NCT04845014) investigated Rilvegostomig over 28 days in 40 patients with end-stage renal disease (ESRD) on hemodialysis who had high phosphate levels (hyperphosphatemia). The primary goal was to measure the change in serum phosphate levels, where a reduction indicates improvement.
- Patients started with an average serum phosphate level of 6.8 mg/dL. After 28 days of treatment with Rilvegostomig, their average serum phosphate level decreased to 4.5 mg/dL, representing an average reduction of 2.3 mg/dL.
- A secondary goal was to see how many patients achieved the target serum phosphate level of less than 5.5 mg/dL. By day 28, 70% of patients (28 out of 40) achieved this target.
Currently Recruiting Trials
Rilvegostomig is currently being investigated in numerous clinical trials across various cancer types, offering potential new treatment options for patients. These studies aim to evaluate the safety and effectiveness of rilvegostomig, often in combination with other therapies.
One significant study, NCT07431281, is a Phase 3 trial enrolling up to 2130 participants with advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. It evaluates sonesitatug vedotin in combination with capecitabine, with or without rilvegostomig, for first-line treatment.
For patients with biliary tract cancer, the Phase 3 ARTEMIDE-Biliary02 study (NCT07221253) is recruiting 1100 individuals. This trial compares rilvegostomig with gemcitabine plus cisplatin against durvalumab with gemcitabine plus cisplatin as a first-line treatment.
In non-small cell lung cancer (NSCLC), several trials are active. A Phase 3 study (NCT06868277) is enrolling 830 participants to compare rilvegostomig monotherapy with pembrolizumab monotherapy for first-line treatment of PD-L1-high metastatic NSCLC. Another Phase 3 trial (NCT06357533) for non-squamous NSCLC with high PD-L1 expression is recruiting 675 participants to assess datopotamab deruxtecan in combination with rilvegostomig, or rilvegostomig monotherapy, against pembrolizumab monotherapy.
Patients with hepatocellular carcinoma may be eligible for a Phase 3 study (NCT06921785) enrolling 1220 participants. This trial investigates rilvegostomig in combination with bevacizumab, with or without tremelimumab, as a first-line treatment.
For HER2-expressing endometrial cancer, a Phase 3 study (NCT06989112) aims to enroll 600 participants, comparing trastuzumab deruxtecan plus rilvegostomig or pembrolizumab as first-line treatment options. Additionally, a Phase 3 study (NCT06764875) for HER2-positive gastric cancer is recruiting 840 participants to evaluate rilvegostomig in combination with fluoropyrimidine and trastuzumab deruxtecan.
Earlier phase studies include a Phase 1 trial (NCT07161414) with 40 participants, focusing on the pharmacokinetics and safety of subcutaneous rilvegostomig in adults with advanced solid tumors. The I-SPY TRIAL (NCT01042379), a large Phase 2 study in breast cancer with an enrollment target of 5000 participants, also includes a block investigating rilvegostomig plus trastuzumab deruxtecan.
Where to Participate
Clinical trials for Rilvegostomig are broadly accessible across the United States, with study sites in 49 states, encompassing 236 cities and a total of 55 research locations. This widespread availability helps ensure diverse patient participation.
Some of the top cities with the most active recruiting sites include:
- New York, New York (25 sites)
- Houston, Texas (18 sites)
- Fairfax, Virginia (15 sites)
- Atlanta, Georgia (14 sites)
- Pittsburgh, Pennsylvania (13 sites)
Eligibility for these studies generally requires participants to be adults, specifically between 18 and 130 years of age. All genders are welcome, but these trials are not open to healthy volunteers or children, focusing instead on patients with specific medical conditions.
Development Timeline
The journey of Rilvegostomig in clinical development began on January 5, 2010, marking the start of its first clinical trial. Initially, the drug's investigation focused on conditions such as IBS-C and hyperphosphatemia. Over time, the research pipeline significantly expanded, shifting its primary focus towards a wide array of oncology indications.
AstraZeneca has been the predominant sponsor, leading 24 of the 30 total trials, demonstrating a strong commitment to advancing this therapy. Other sponsors, including Presage Biosciences, have also contributed to its development. The latest trial is projected to conclude by February 24, 2026, indicating ongoing and future research efforts.
The development program has progressed through various phases, with a substantial number of studies reaching advanced stages. There are 12 trials currently in Phase 3, 11 in Phase 2, three in Phase 1/Phase 2, and two each in Phase 1 and Early Phase 1. This progression reflects the growing understanding of Rilvegostomig's potential and its movement towards potential approval for multiple cancer types. The total enrollment across all trials has reached over 19,108 participants, underscoring the extensive research efforts dedicated to this investigational drug.