Trial: A Study of Novel Study Interventions an…

Trial Details

Sponsor: AstraZeneca (industry)

Phase: 2

Start date: March 12, 2025

Planned enrollment: 120

Trial ID: NCT06792695

More trial details at ClinicalTrials.gov

Show Summary from Sponsor

Investigational Drug AI Analysis

Show for: Volrustomig (MEDI5752, PD-1/CTLA-4 DuetMab, MEDI-5752)

Overview

Volrustomig (MEDI5752/MEDI-5752) is an investigational, humanized IgG1 bispecific antibody designed to inhibit both PD-1 and CTLA-4. It is being evaluated alone and in combination regimens across several solid tumors. Early-phase studies have shown antitumor activity, but results vary by tumor type and dose, and efficacy remains unconfirmed in successful randomized phase III trials. (pmc.ncbi.nlm.nih.gov)

In August 2026, the 895-patient phase III eVOLVE-Lung02 trial in first-line metastatic non-small cell lung cancer (NSCLC) was discontinued after an independent monitoring committee concluded that volrustomig plus chemotherapy was unlikely to improve progression-free or overall survival over pembrolizumab plus chemotherapy in the primary PD-L1-negative population. Detailed results have not yet been published. Other phase III studies in cervical cancer, head and neck squamous cell carcinoma (HNSCC), and mesothelioma are continuing. (astrazeneca.com)

Mechanism of action

Volrustomig uses PD-1 binding to concentrate CTLA-4 blockade on activated, PD-1-positive T cells. This design is intended to provide sustained PD-1 inhibition while preferentially inhibiting CTLA-4 on activated rather than resting peripheral T cells, potentially limiting systemic CTLA-4-related toxicity. Pharmacodynamic studies have demonstrated peripheral and intratumoral T-cell proliferation and activation. (aacrjournals.org)

Efficacy

Advanced solid tumors, phase I: Among 86 patients receiving monotherapy across multiple tumor types and doses, the objective response rate (ORR) was 19.8%, including 2.3% complete responses; disease control rate was 53.5%. Median duration of response was 17.5 months, median progression-free survival (PFS) 3.7 months, and median overall survival 19.2 months. The heterogeneous population and nonrandomized design limit interpretation. (doi.org)
First-line advanced clear-cell renal cell carcinoma, phase I expansion: ORRs were 46.9% with 750 mg and 45.5% with 500 mg every three weeks. Complete-response rates were 9.4% and 6.1%, respectively; median PFS was 11.1 and 9.9 months. (annalsofoncology.org)
Recurrent/metastatic HNSCC, phase II interim analysis: Among 19 patients with PD-L1 combined positive score ≥1, five partial responses produced a confirmed ORR of 26.3% and disease-control rate of 52.6%. Follow-up was short at 5.4 months. (ascopubs.org)
Metastatic NSCLC, phase III: eVOLVE-Lung02 was stopped for futility; the regimen was considered unlikely to meet its PFS or overall-survival endpoints versus pembrolizumab plus chemotherapy in patients with PD-L1-negative tumors. Numerical efficacy results have not been released. (astrazeneca.com)

Safety

In the 86-patient phase I monotherapy study, 84.9% experienced treatment-related adverse events (TRAEs), including 38.4% with grade 3–4 events. Common TRAEs included pruritus (30.2%), hypothyroidism (26.7%), hyperthyroidism (24.4%), rash (24.4%), and elevated AST (18.6%). TRAEs caused treatment discontinuation in 33.7%, and one treatment-related death was reported. Hepatic toxicity and discontinuations were more frequent at doses of 1,500 mg or higher, indicating dose-dependent tolerability. (pmc.ncbi.nlm.nih.gov)

In the small HNSCC phase II analysis, grade 3–4 treatment-related events occurred in 8.7% of patients; no patient discontinued because of an adverse event. (ascopubs.org)

TrialFetch AI Analysis

Goal: Evaluate whether adding volrustomig to first-line FOLFIRI plus bevacizumab improves outcomes while maintaining acceptable safety in pMMR/MSS metastatic colorectal cancer without liver metastases.

Patients: Adults with histologically confirmed, measurable pMMR/MSS metastatic colorectal adenocarcinoma, no radiologic liver metastases, ECOG performance status 0–1, and no prior systemic treatment for metastatic disease. Prior neoadjuvant or adjuvant chemotherapy is permitted if recurrence was diagnosed more than 6 months after completion. Key exclusions include CNS metastases, potentially resectable disease, prior immune-mediated therapy, and specified autoimmune, cardiovascular, thrombotic, or bleeding risks.

Design: Open-label, multicenter, randomized comparison within a global phase II platform master protocol. Participants are assigned to the investigational combination or an active-control regimen.

Treatments: The experimental arm adds volrustomig to FOLFIRI (irinotecan, fluorouracil, and leucovorin) plus bevacizumab; the control arm receives FOLFIRI plus bevacizumab. Volrustomig is an investigational bispecific antibody targeting PD-1 and CTLA-4, designed to concentrate CTLA-4 blockade on activated PD-1–positive T cells. In a heterogeneous phase I monotherapy study, the objective response rate was 19.8%, but efficacy in this colorectal cancer population is unproven; a phase III study in metastatic non-small cell lung cancer was stopped for futility. FOLFIRI plus bevacizumab is a chemotherapy and anti-VEGF regimen used for metastatic colorectal cancer.

Outcomes: Primary measures are RECIST 1.1 progression-free survival and adverse events. Secondary measures include objective response rate, overall survival, disease control rate, duration of response, time to second progression or death, volrustomig pharmacokinetics, and anti-drug antibodies, assessed over approximately 3 years.

Burden on patient: Moderate to high. Both arms require repeated clinic visits for intravenous chemotherapy and bevacizumab, with additional volrustomig administration in the experimental arm. Serial imaging and safety assessments are expected, along with blood sampling for pharmacokinetics and anti-drug antibodies. An archival or standard-of-care FFPE tumor sample is required; the supplied protocol does not specify a mandatory new biopsy or the frequency of pharmacokinetic draws.

Last updated: Sep 2026

Eligibility

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Woodville South, 5011, Australia

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Wollongong, 2500, Australia

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East Melbourne, 3002, Australia

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Victoria, British Columbia, V8R 6V5, Canada

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Barrie, Ontario, L4M 6M2, Canada

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Toronto, Ontario, M5G 1X6, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Poitiers, 86021, France

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Saint-Priez En Jarez, 42270, France

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Villejuif, 94805, France

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Essen, 45147, Germany

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Dresden, 01307, Germany

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Hamburg, 22763, Germany

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Marburg, 35043, Germany

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Florence, 50134, Italy

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Bologna, 40133, Italy

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Amsterdam, 1066 CX, Netherlands

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Maastricht, 6202 AZ, Netherlands

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Zwolle, 8025 AB, Netherlands

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Seoul, 03080, South Korea

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Seoul, 06351, South Korea

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Seoul, 06591, South Korea

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Seoul, 5505, South Korea

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Yongin-si, 16995, South Korea

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Valencia, 46010, Spain

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Barcelona, 08035, Spain

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Barcelona, 8003, Spain

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Madrid, 28034, Spain

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Madrid, 28041, Spain

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Málaga, 29010, Spain

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Pamplona, 31005, Spain

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Santander, 39008, Spain

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Kaohsiung City, 80756, Taiwan

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Taipei, 10002, Taiwan

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Taoyuan District, 333, Taiwan

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Yung Kang City, 71044, Taiwan

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London, W12 0HS, United Kingdom

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Manchester, M20 4GJ, United Kingdom

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Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

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Cambridge, CB2 0XY, United Kingdom

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London, NW1 2PG, United Kingdom

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Scottsdale, Arizona, 85259, United States

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Los Angeles, California, 90089, United States

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Baltimore, Maryland, 21224, United States

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Rochester, Minnesota, 55905, United States

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Rochester, New York, 14618, United States

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Houston, Texas, 77030, United States

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Beijing, 100142, China

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Shanghai, 201114, China

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Shanghai, 200003, China

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Harbin, 150081, China

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Montpellier, 34090, France

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Montpellier, 34298, France

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Bordeaux, 33076, France

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Berlin, 10117, Germany

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Roma, 00168, Italy

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Milan, 20133, Italy

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Castelfranco Veneto, 31033, Italy

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Milan, 20162, Italy

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Naples, 80131, Italy

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Pavia, 27100, Italy

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Pisa, 56100, Italy

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Madrid, 28007, Spain

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Washington D.C., District of Columbia, 20007, United States

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Chicago, Illinois, 60637, United States

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Trenton, New Jersey, 08690, United States

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Portland, Oregon, 97239, United States

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Nashville, Tennessee, 37232, United States

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Boston, Massachusetts, 02114, United States

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Marseille, 13273, France

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Cleveland, Ohio, 44106, United States

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Philadelphia, Pennsylvania, 19104, United States

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Zhengzhou, 450000, China

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Wuhan, 430079, China

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Shanghai, 200032, China

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Chengdu, 610041, China

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A Phase II, Open-label, Multicenter, Master Protocol to Evaluate the Safety and Efficacy of Novel Study Interventions and Combinations in Participants With Colorectal Cancer (CANTOR)

Trial Details

Show Summary from Sponsor

More details:

Investigational Drug AI Analysis

Show for: Volrustomig (MEDI5752, PD-1/CTLA-4 DuetMab, MEDI-5752)

Overview

Mechanism of action

Efficacy

Safety

Further reading

TrialFetch AI Analysis

Eligibility

Show Criteria

Sites (76)

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