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NCT06884618RecruitingPhase 1

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)

A Phase I Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Clinical Activity of RO7673396 as a Single Agent and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors Harboring RAS Mutation(s)

Source: ClinicalTrials.gov · Last updated 28 Sept 2026

Brief summary (registry, in English)

This study aims to evaluate the safety and tolerability of RO7673396 in participants with advanced solid tumors harboring RAS mutation(s). This study consists of two stages: Stage 1 (Dose Escalation) and Stage 2 (Dose Expansion). Stage 1 will define the recommended dose(s) for expansion (RDEs) of RO7673396. Stage 2 will evaluate preliminary anti-tumor activity of the RDE(s) defined in Stage 1 and of other doses of interest for future development in selected solid tumor indications.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
405 (estimated)
First submitted
18 Mar 2025
Start date
30 Apr 2025
Primary completion date
31 Aug 2028
Lead sponsor
Hoffmann-La Roche
Diseases
Sarcoma
NCT number
NCT06884618
EU CT number
2024-519622-20-00

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 405
  • From 30 Apr 2025 to the primary completion date, 31 Aug 2028
  • 25 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate study treatment absorption
  • Treatment with chemotherapy, immunotherapy, biologic therapy, or an investigational agent as anti-cancer therapy within 4 weeks or five half-lives prior to initiation of study treatment
  • Major surgical procedure within 28 days prior to initiation of study treatment, or incomplete recovery from surgery that would interfere with the determination of safety or efficacy of study treatment, or anticipation of need for a major surgical procedure during the study

Other illness

  • Known hypersensitivity or medical contraindication to any component of RO7673396 formulation
  • Participants with chronic diarrhea, short bowel syndrome or significant upper gastrointestinal (GI) surgery including gastric resection, a history of inflammatory bowel disease (IBD)
  • A history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, non-infectious ILD/pneumonitis, or current evidence of active pneumonitis or ILD on screening chest CT scan
  • Known clinically significant liver disease

Other

  • Current participant or enrollment in another interventional clinical trial
  • Known and untreated, or active central nervous system (CNS) metastases
  • Participants who are on acid-reducing agents and unable to safely discontinue them as required in the study
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures

Who the study is looking for

  • 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 ≥12 weeks
  • Adequate hematologic and end-organ function
  • Confirmed presence of the RAS mutation(s)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (25)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
St Vincent's Hospital Sydney
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DarlinghurstAustraliaRecruiting
Peter MacCallum Cancer Center
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ParkvilleAustraliaRecruiting
Princess Margaret Hospital
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TorontoCanadaRecruiting
Sun Yat-Sen University Cancer Center;Department of Thoracic Surgery
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting
Sun Yat-Sen University Cancer Center - Huangpu Campus
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GuangzhouChinaRecruiting
Fudan University Shanghai Cancer Center
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ShanghaiChinaRecruiting
Hubei Cancer Hospital
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WuhanChinaRecruiting
Rigshospitalet
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København ØDenmarkRecruiting
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
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BarcelonaSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Clínica Universidad de navarra
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PamplonaSpainRecruiting
New Queen Elizabeth Hospital Birmingham
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BirminghamUnited KingdomRecruiting
St. Bartholomew's Hospital
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LondonUnited KingdomRecruiting
Prince of Wales Hospital
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Hong KongHong Kong SAR ChinaRecruiting
New Zealand Clinical Research - Auckland
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AucklandNew ZealandRecruiting
New Zealand Clinical Research - Christchurch
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ChristchurchNew ZealandRecruiting
National Cancer Centre - 30 Hospital Blvd
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SingaporeSingaporeRecruiting
National Cheng Kung University Hospital
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TainanTaiwanRecruiting
National Taiwan University Hospital
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TaipeiTaiwanRecruiting
UCHealth Lung Cancer Clinic - Anschutz Medical Campus - PPDS
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AuroraUnited StatesRecruiting
City of Hope Comprehensive Cancer Center
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DuarteUnited StatesRecruiting
MD Anderson Cancer Center
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HoustonUnited StatesRecruiting
Smilow Cancer Hospital at Yale - New Haven
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New HavenUnited StatesRecruiting
South Texas Accelerated Research Therapeutics (START)
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San AntonioUnited StatesRecruiting
Florida Cancer Specialists - Sarasota (North Catttlemen Rd)
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SarasotaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.