Non-small Cell Lung CancerPhase 1NCT05867121
A Study to Evaluate Safety, Pharmacokinetics, & Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-care Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors; Urothelial Carcinoma Substudy in Association With RO7496353 Study GO44010
A Phase 1 study testing RO7496353, Atezolizumab and Capecitabine in people with Non-small Cell Lung Cancer and Gastric Cancer, run by Genentech, Inc. at 27 sites in 9 countries.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of RO7496353 in combination with a checkpoint inhibitor (CPI) with or without standard-of-care (SOC) chemotherapy in participants with locally advanced or metastatic solid tumors such as non-small cell lung cancer (NSCLC), gastric cancer (GC) and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Gastric Cancer, Pancreatic Ductal Adenocarcinoma
- What is being tested?
- RO7496353, Atezolizumab and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 27 sitesin 9 countries
- Study dates
- 2 Oct 2023to 16 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
27 sites in 9 countries.
27 sites in 9 countries
Japan5 sites
National Cancer Center Hospital East
Chiba, 277-8577
Kanagawa Cancer Center
Kanagawa, 241-8515
Shizuoka Cancer Center
Shizuoka, 411-8777
National Cancer Center Hospital
Tokyo, 104-0045
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Tokyo, 135-8550
South Korea5 sites
Seoul National University Hospital
Seoul, 03080
Asan Medical Center
Seoul, 05505
Samsung Medical Center - PPDS
Seoul, 06351
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy
Seoul, 120-752
Spain4 sites
Clinica Universidad de Navarra-Madrid
Madrid, 28027
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008
NEXT Oncology-Hospital Quironsalud Madrid
Pozuelo de Alarcón, Madrid, 28223
Hospital Clinico Universitario de Valencia
Valencia, 46010
United States3 sites
UCLA University of California Los Angeles
Los Angeles, California, 90095
Yale School of Medicine
New Haven, Connecticut, 06510-3206
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Italy3 sites
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
Milan, Lombardy, 20162
Fondazione Policlinico Universitario A Gemelli
Rome, Lazio, 00168
Centro Ricerche Cliniche Di Verona
Verona, Veneto, 37134
Australia2 sites
Flinders Medical Centre
Bedford Park, South Australia, 5042
St Vincent'S Hospital
Darlinghurst, New South Wales, 2010
Brazil2 sites
Hospital de Câncer de Barretos
Barretos, São Paulo, 14784-400
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre, Rio Grande do Sul, 90610-000
Turkey (Türkiye)2 sites
Ankara City Hospital
Ankara, 06800
Dokuz Eylul Universitesi Tip Fakultesi
Lzmir, 35340
About this study
Official title: A Phase Ib, Open-label, Multicenter Dose-expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-care Chemotherapy in Patients With Locally Advanced or Metastatic Solid Tumors
The purpose of this study is to evaluate the safety and tolerability of RO7496353 in combination with a checkpoint inhibitor (CPI) with or without standard-of-care (SOC) chemotherapy in participants with locally advanced or metastatic solid tumors such as non-small cell lung cancer (NSCLC), gastric cancer (GC) and pancreatic ductal adenocarcinoma (PDAC).
The substudy will evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of RO7496353 in combination with atezolizumab in patients with locally advanced or metastatic urothelial carcinoma (UC).
The parent and substudy will be conducted in 2 stages: an initial safety run-in stage and an expansion stage.
- Being tested
- RO7496353, Atezolizumab, Capecitabine, S-1, Nivolumab
- Keywords
- Urothelial Carcinoma
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7496353Drug
Also called SOF 10
RO7496353 will be administered as per the schedules specified in the respective arms.
AtezolizumabDrug
Also called RO5541267; Tecentriq
Atezolizumab will be administered as per the schedules specified in the respective arms.
CapecitabineDrug
Capecitabine will be administered as per the schedule specified in the respective arm.
S-1Drug
Also called Tegafur/Gimeracil/Oteracil potassium
S-1 will be administered as per the schedule specified in the respective arm.
NivolumabDrug
Nivolumab will be administered as per the schedule specified in the respective arm.
OxaliplatinDrug
Oxaliplatin will be administered as per the schedule specified in the respective arm.
Nab-paclitaxelDrug
Nab-paclitaxel will be administered as per the schedule specified in the respective arm.
GemcitabineDrug
Gemcitabine will be administered as per the schedule specified in the respective arm.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: NSCLC | Experimental | Participants with NSCLC will receive RO7496353, and atezolizumab, given as an intravenous (IV) infusion at an assigned dose on Day 1 of each 21-day cycle until unacceptable toxicity or symptomatic deterioration attributed to disease progression (PD). Receives: Drug: RO7496353; Drug: Atezolizumab |
| Cohort B: GC | Experimental | Participants with GC will receive RO7496353, nivolumab, and oxaliplatin, given as an IV infusion at an assigned dose on Day 1 of each 21-day cycle along with either capecitabine or S-1, orally, twice daily on Days 1 to 14 of each cycle until unacceptable toxicity or symptomatic deterioration attributed to PD. Receives: Drug: RO7496353; Drug: Capecitabine; Drug: S-1; Drug: Nivolumab; Drug: Oxaliplatin |
| Cohort C: PDAC | Experimental | Participants with PDAC will receive RO7496353, and atezolizumab, given as an IV infusion at an assigned dose on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, and gemcitabine, also given as an IV infusion on Days 1, 8, 15 of each 28-day cycle until unacceptable toxicity or symptomatic deterioration attributed to PD. Receives: Drug: RO7496353; Drug: Atezolizumab; Drug: Nab-paclitaxel; Drug: Gemcitabine |
| Substudy: UC | Experimental | Participants with UC will receive RO7496353, and atezolizumab, given as an IV infusion at an assigned dose on Day 1 of each 21-day cycle until unacceptable toxicity or symptomatic deterioration attributed to PD. Receives: Drug: RO7496353; Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs)
AEs will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).
Measured: Up to approximately 33 months
Secondary outcomes (5)
Plasma Concentration of RO7496353
Measured: Up to approximately 33 months
Percentage of Participants With Anti-drug Antibody (ADA) to RO7496353
Measured: Up to approximately 33 months
Confirmed Objective Response Rate (ORR) as Determined by the Investigator per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Measured: Up to approximately 33 months
Duration of Response (DOR) as Determined by the Investigator per RECIST v1.1
Measured: Up to approximately 33 months
Progression-free Survival (PFS) as Determined by the Investigator per RECIST v1.1
Measured: Up to approximately 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start2 Oct 2023
- Primary completion16 Mar 2026
- Study completion16 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chugai Pharmaceutical
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867121
- Sponsor's protocol ID
- GO44010
- Other IDs
- 2022-502615-11-00
- Status last verified
- Jun 2026
- First submitted
- 10 May 2023
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Open-label, Multicenter Dose-expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-care Chemotherapy in Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05867121
- Acronym / sponsor ID
- GO44010
- Keywords
- Urothelial Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Chugai Pharmaceutical
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 16 Mar 2026 (actual)
- Study completion
- 16 Mar 2026 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and tolerability of RO7496353 in combination with a checkpoint inhibitor (CPI) with or without standard-of-care (SOC) chemotherapy in participants with locally advanced or metastatic solid tumors such as non-small cell lung cancer (NSCLC), gastric cancer (GC) and pancreatic ductal adenocarcinoma (PDAC).
The substudy will evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of RO7496353 in combination with atezolizumab in patients with locally advanced or metastatic urothelial carcinoma (UC).
The parent and substudy will be conducted in 2 stages: an initial safety run-in stage and an expansion stage.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A: NSCLC | Experimental | Drug: RO7496353, Drug: AtezolizumabParticipants with NSCLC will receive RO7496353, and atezolizumab, given as an intravenous (IV) infusion at an assigned dose on Day 1 of each 21-day cycle until unacceptable toxicity or symptomatic deterioration attributed to disease progression (PD). |
| Cohort B: GC | Experimental | Drug: RO7496353, Drug: Capecitabine, Drug: S-1, Drug: Nivolumab, Drug: OxaliplatinParticipants with GC will receive RO7496353, nivolumab, and oxaliplatin, given as an IV infusion at an assigned dose on Day 1 of each 21-day cycle along with either capecitabine or S-1, orally, twice daily on Days 1 to 14 of each cycle until unacceptable toxicity or symptomatic deterioration attributed to PD. |
| Cohort C: PDAC | Experimental | Drug: RO7496353, Drug: Atezolizumab, Drug: Nab-paclitaxel, Drug: GemcitabineParticipants with PDAC will receive RO7496353, and atezolizumab, given as an IV infusion at an assigned dose on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, and gemcitabine, also given as an IV infusion on Days 1, 8, 15 of each 28-day cycle until unacceptable toxicity or symptomatic deterioration attributed to PD. |
| Substudy: UC | Experimental | Drug: RO7496353, Drug: AtezolizumabParticipants with UC will receive RO7496353, and atezolizumab, given as an IV infusion at an assigned dose on Day 1 of each 21-day cycle until unacceptable toxicity or symptomatic deterioration attributed to PD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RO7496353Also: SOF 10RO7496353 will be administered as per the schedules specified in the respective arms. | Drug | Cohort A: NSCLC, Cohort B: GC, Cohort C: PDAC, Substudy: UC |
| AtezolizumabAlso: RO5541267; TecentriqAtezolizumab will be administered as per the schedules specified in the respective arms. | Drug | Cohort A: NSCLC, Cohort C: PDAC, Substudy: UC |
| CapecitabineCapecitabine will be administered as per the schedule specified in the respective arm. | Drug | Cohort B: GC |
| S-1Also: Tegafur/Gimeracil/Oteracil potassiumS-1 will be administered as per the schedule specified in the respective arm. | Drug | Cohort B: GC |
| NivolumabNivolumab will be administered as per the schedule specified in the respective arm. | Drug | Cohort B: GC |
| OxaliplatinOxaliplatin will be administered as per the schedule specified in the respective arm. | Drug | Cohort B: GC |
| Nab-paclitaxelNab-paclitaxel will be administered as per the schedule specified in the respective arm. | Drug | Cohort C: PDAC |
| GemcitabineGemcitabine will be administered as per the schedule specified in the respective arm. | Drug | Cohort C: PDAC |
Primary outcome
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to approximately 33 months
AEs will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).
5 secondary outcomes
Plasma Concentration of RO7496353
Time frame: Up to approximately 33 months
Percentage of Participants With Anti-drug Antibody (ADA) to RO7496353
Time frame: Up to approximately 33 months
Confirmed Objective Response Rate (ORR) as Determined by the Investigator per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time frame: Up to approximately 33 months
Duration of Response (DOR) as Determined by the Investigator per RECIST v1.1
Time frame: Up to approximately 33 months
Progression-free Survival (PFS) as Determined by the Investigator per RECIST v1.1
Time frame: Up to approximately 33 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
27 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO7496353, Atezolizumab and Capecitabine in people with Non-small Cell Lung Cancer and Gastric Cancer, run by Genentech, Inc. at 27 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Japan, South Korea, Spain, United States, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Adverse Events (AEs) (time frame: Up to approximately 33 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.