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New drug combo shows promise in early cancer trial

NCT ID NCT05867121

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

102 people

The number who actually took part.

Started

Oct 2023

Finished

Mar 2026

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda

    Milan, Lombardy, 20162, Italy

  • Ankara City Hospital

    Ankara, 06800, Turkey (Türkiye)

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Auckland City Hospital

    Auckland, 1023, New Zealand

  • Centro Ricerche Cliniche Di Verona

    Verona, Veneto, 37134, Italy

  • Clinica Universidad de Navarra-Madrid

    Madrid, 28027, Spain

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008, Spain

  • Dokuz Eylul Universitesi Tip Fakultesi

    Lzmir, 35340, Turkey (Türkiye)

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042, Australia

  • Fondazione Policlinico Universitario A Gemelli

    Rome, Lazio, 00168, Italy

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Hospital de Câncer de Barretos

    Barretos, São Paulo, 14784-400, Brazil

  • Kanagawa Cancer Center

    Kanagawa, 241-8515, Japan

  • NEXT Oncology-Hospital Quironsalud Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • National Cancer Center Hospital

    Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Chiba, 277-8577, Japan

  • Samsung Medical Center - PPDS

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy

    Seoul, 120-752, South Korea

  • Shizuoka Cancer Center

    Shizuoka, 411-8777, Japan

  • St Vincent'S Hospital

    Darlinghurst, New South Wales, 2010, Australia

  • The Cancer Institute Hospital of Japanese Foundation For Cancer Research

    Tokyo, 135-8550, Japan

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591, South Korea

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • UCLA University of California Los Angeles

    Los Angeles, California, 90095, United States

  • Yale School of Medicine

    New Haven, Connecticut, 06510-3206, United States

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