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RO7673396

Phase 1

Neoplasms | Small molecule | Oncology |Roche Holding AG|Last Updated: Apr 21, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment405

FDA Designations

No designations recorded

Clinical trial landscape

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 Sites21

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 ZealandSingaporeSpainTaiwan
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Frequently asked questions about RO7673396

What is RO7673396 used for?

RO7673396 is an investigational small molecule being developed for the treatment of advanced solid tumors that harbor rat sarcoma viral oncogene homolog (RAS) mutations. It is currently in Phase 1 clinical development for neoplasms, which are abnormal growths of tissue that can be benign or malignant.

What does RO7673396 target?

RO7673396 targets tumors that harbor rat sarcoma viral oncogene homolog (RAS) mutations. The drug is designed to address cancers with these specific genetic alterations, which are common drivers of tumor growth. It is being studied in patients with advanced solid tumors that test positive for RAS mutations.

Who makes RO7673396?

RO7673396 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY on the OTC market. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational oncology drug.

What phase is RO7673396 in?

RO7673396 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 in clinical trials. The Phase 1 study is currently recruiting participants to evaluate the drug's safety, tolerability, and preliminary clinical activity.

What clinical trials is RO7673396 in?

RO7673396 is being studied in a Phase 1 clinical trial with the identifier NCT06884618. This trial is evaluating the safety, tolerability, pharmacokinetics, and preliminary clinical activity of RO7673396 in participants with advanced solid tumors harboring RAS mutations. The study is recruiting and aims to enroll 405 participants across multiple countries.

Is RO7673396 the same as other RAS-targeting drugs?

RO7673396 is a distinct investigational small molecule being developed by Roche. It is designed to target tumors with RAS mutations, a class of genetic alterations found in many cancers. While other drugs may also target RAS mutations, RO7673396 is a unique compound with its own chemical structure and clinical development program.