Recent Updates
Recently added Catalysts

RO7496353

Phase 1

Non-small Cell Lung Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Jun 18, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment102

FDA Designations

No designations recorded

Clinical trial landscape

RO7496353 · 1 trial · 3 indications

Phase 1 1
NCT05867121A 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 GO44010Non-small Cell Lung Cancer
COMPLETED102 Analytics
PHASE1COMPLETED
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
Non-small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Adverse Events (AEs)
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).

Secondary Endpoints

Plasma Concentration of RO7496353
Up to approximately 33 months
Percentage of Participants With Anti-drug Antibody (ADA) to RO7496353
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)
Up to approximately 33 months
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort A: NSCLCEXPERIMENTALParticipants 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: GCEXPERIMENTALParticipants 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: PDACEXPERIMENTALParticipants 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: UCEXPERIMENTALParticipants 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.

Interventions

NameTypeDescription
RO7496353DRUGRO7496353 will be administered as per the schedules specified in the respective arms.
AtezolizumabDRUGAtezolizumab will be administered as per the schedules specified in the respective arms.
CapecitabineDRUGCapecitabine will be administered as per the schedule specified in the respective arm.
S-1DRUGS-1 will be administered as per the schedule specified in the respective arm.
NivolumabDRUGNivolumab will be administered as per the schedule specified in the respective arm.
OxaliplatinDRUGOxaliplatin will be administered as per the schedule specified in the respective arm.
Nab-paclitaxelDRUGNab-paclitaxel will be administered as per the schedule specified in the respective arm.
GemcitabineDRUGGemcitabine will be administered as per the schedule specified in the respective arm.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites27

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 disea...

Countries:United StatesAustraliaBrazilItalyJapanNew ZealandSouth KoreaSpainTurkey (Türkiye)
Unlock Eligibility Criteria

Competitive Landscape -Non-Small Cell Lung Cancer 389 trials

Recent Changes (Last 90 Days)

MEDIUMJul 19, 2026NCT05867121TRIAL_REMOVED: changed
MEDIUMJul 19, 2026NCT05867121TRIAL_REMOVED: changed
MEDIUMJul 19, 2026NCT05867121TRIAL_REMOVED: changed
MEDIUMJul 19, 2026NCT05867121TRIAL_REMOVED: changed

Frequently asked questions about RO7496353

What is RO7496353 used for?

RO7496353 is an investigational small molecule being studied for the treatment of non-small cell lung cancer, as well as gastric cancer and pancreatic ductal adenocarcinoma. It is being evaluated in combination with a checkpoint inhibitor, with or without standard-of-care chemotherapy, in patients with locally advanced or metastatic solid tumors.

Who makes RO7496353?

RO7496353 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this investigational small molecule for oncology indications.

What phase is RO7496353 in?

RO7496353 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety, pharmacokinetics, and activity in clinical trials.

What clinical trials is RO7496353 in?

RO7496353 is being studied in clinical trial NCT05867121, a Phase 1 study evaluating its safety, pharmacokinetics, and activity in combination with a checkpoint inhibitor, with or without standard-of-care chemotherapy, in patients with locally advanced or metastatic solid tumors. The trial has been completed.

Is RO7496353 the same as another drug?

RO7496353 is also known by the study identifier GO44010, as referenced in the clinical trial title. This identifier is used to associate the drug with its specific clinical study program.