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RO7673396

Phase 1

Neoplasms | Small molecule | Oncology |Roche Holding AG|Trials Updated: Sep 28, 2026

RO7673396 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment405

FDA Designations

No designations recorded

RO7673396 clinical trials

RO7673396 · 1 trial · 1 indication

Phase 1 1
NCT06884618A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Clinical Activity of RO7673396 in Participants With Advanced Solid Tumors Harboring Rat Sarcoma Viral Oncogene Homolog (RAS) Mutation(s)Neoplasms
RECRUITING405 Analytics
PHASE1RECRUITING
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Clinical Activity of RO7673396 in Participants With Advanced Solid Tumors Harboring Rat Sarcoma Viral Oncogene Homolog (RAS) Mutation(s)
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Study Endpoints

Primary Endpoints

Stage I: Number of Participants With Adverse Events (AEs)
Up to approximately 40 months
Stage I: Number of Participants With Dose-limiting Toxicities (DLTs)
Up to Day 21
Stage II: Objective Response Rate (ORR) as Assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)
Up to approximately 40 months

Secondary Endpoints

Plasma Concentrations of RO7673396 and its Metabolite(s)
Up to approximately 49 months
Stage I: ORR as Assessed by the Investigator per RECIST V1.1
Up to approximately 49 months
Stage I and II: Duration of Response (DOR) as Assessed by the Investigator per RECIST V1.1
Up to approximately 49 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Stage IEXPERIMENTALParticipants with advanced solid tumors harboring RAS mutations will receive multiple ascending doses of RO7673396, as per a pre-defined dosing regimen until unacceptable toxicity or disease progression (PD) and/or loss of clinical benefit as determined by the investigator.
Stage IIEXPERIMENTALParticipants with advanced solid tumors harboring RAS mutations will receive RO7673396 at the dose determined in Stage 1, until unacceptable toxicity or PD and/or loss of clinical benefit as determined by the investigator.

Interventions

NameTypeDescription
RO7673396DRUGRO7673396 will be administered as per the schedule specified in the protocol.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * Histologically documented, locally advanced, recurrent, or metastatic incurable solid tumors * Participants with measurable disease according to RECIST v1.1 assessed by the investigator * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy ...

Countries:United StatesAustraliaCanadaChinaDenmarkHong KongNew ZealandSingaporeSpainTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)

LOWSep 28, 2026NCT06884618lastUpdatePostDate: changed
LOWSep 28, 2026NCT06884618lastUpdatePostDate: changed

Frequently asked questions about RO7673396

What is RO7673396 used for?

RO7673396 is an investigational small molecule being studied for the treatment of advanced solid tumors that harbor RAS mutations. It is in Phase 1 clinical development in oncology and has not been approved for any indication. The trial enrolls adults with advanced solid tumors whose tumors carry a RAS mutation.

Who is developing RO7673396?

RO7673396 is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sponsor of the Phase 1 clinical program evaluating the compound in patients with advanced solid tumors harboring RAS mutations.

What phase is RO7673396 in?

RO7673396 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. The single ongoing Phase 1 trial is currently recruiting participants and is designed to evaluate safety, tolerability, pharmacokinetics, and preliminary clinical activity.

What clinical trials is RO7673396 in?

RO7673396 is being evaluated in one active Phase 1 trial, NCT06884618, titled a study to evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical activity of RO7673396 in participants with advanced solid tumors harboring RAS mutations. The trial is recruiting and plans to enroll 405 participants across the United States, Australia, Canada, China, Denmark, Hong Kong, New Zealand, Singapore, Spain, Taiwan, and the United Kingdom.

What does RO7673396 target?

RO7673396 targets RAS-mutant tumors. The Phase 1 trial NCT06884618 specifically enrolls patients with advanced solid tumors harboring rat sarcoma viral oncogene homolog (RAS) mutations, indicating that the compound is designed to address cancers driven by RAS mutations. It is a small molecule therapeutic.