New drug combo shows promise in early cancer trial
NCT ID NCT05867121
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested a new drug called RO7496353 combined with an immunotherapy (atezolizumab) and sometimes chemotherapy in 102 people with advanced lung, stomach, or pancreatic cancer. The main goal was to check safety and side effects. Researchers also looked at how the drug moves through the body and whether it shrinks tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RO7496353 (a drug) combined with atezolizumab (an immunotherapy) and/or chemotherapy drugs like capecitabine, S-1, or nivolumab
- What this could lead to
- If it works, this could point toward a new treatment option for people with advanced solid tumors that are hard to treat.
- What could go wrong
- This is an early Phase 1 trial, so the main goal is safety, not effectiveness. The combination may not work well or could cause serious side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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102 people
The number who actually took part.
- Started
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Oct 2023
- Finished
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Mar 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy of at least 3 months * Adequate hematologic and end-organ function * Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy * Measurable disease according to RECIST v1.1 on computed tomography (CT) or magnetic resonance imaging (MRI) images within 28 days prior to enrollment * Availability of representative tumor specimens in formalin-fixed, paraffin-embedded (FFPE) blocks or at least 15 unstained slides Exclusion Criteria: * Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases * Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina * History of leptomeningeal disease * Uncontrolled tumor-related pain * Positive test for human immunodeficiency virus (HIV) infection * Positive hepatitis B surface antigen (HbsAg) test, and/or positive total hepatitis B core antibody (HbcAb) test at screening * Positive hepatitis C virus (HCV) antibody test at screening * Known allergy or hypersensitivity to any component of the RO7496353 formulation or any of the study drugs or their excipients Other protocol-defined inclusion/exclusion criteria may apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
Milan, Lombardy, 20162, Italy
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Ankara City Hospital
Ankara, 06800, Turkey (Türkiye)
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Asan Medical Center
Seoul, 05505, South Korea
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Auckland City Hospital
Auckland, 1023, New Zealand
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Centro Ricerche Cliniche Di Verona
Verona, Veneto, 37134, Italy
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Clinica Universidad de Navarra-Madrid
Madrid, 28027, Spain
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Clinica Universitaria de Navarra
Pamplona, Navarre, 31008, Spain
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Dokuz Eylul Universitesi Tip Fakultesi
Lzmir, 35340, Turkey (Türkiye)
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Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
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Fondazione Policlinico Universitario A Gemelli
Rome, Lazio, 00168, Italy
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Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
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Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
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Hospital de Câncer de Barretos
Barretos, São Paulo, 14784-400, Brazil
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Kanagawa Cancer Center
Kanagawa, 241-8515, Japan
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NEXT Oncology-Hospital Quironsalud Madrid
Pozuelo de Alarcón, Madrid, 28223, Spain
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National Cancer Center Hospital
Tokyo, 104-0045, Japan
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National Cancer Center Hospital East
Chiba, 277-8577, Japan
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Samsung Medical Center - PPDS
Seoul, 06351, South Korea
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Seoul National University Hospital
Seoul, 03080, South Korea
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Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy
Seoul, 120-752, South Korea
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Shizuoka Cancer Center
Shizuoka, 411-8777, Japan
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St Vincent'S Hospital
Darlinghurst, New South Wales, 2010, Australia
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The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Tokyo, 135-8550, Japan
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The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591, South Korea
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Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
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UCLA University of California Los Angeles
Los Angeles, California, 90095, United States
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Yale School of Medicine
New Haven, Connecticut, 06510-3206, United States
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