NeoplasmsPhase 1NCT06884618
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 1 study testing RO7673396 in people with Neoplasms, run by Hoffmann-La Roche at 25 sites in 11 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- RO7673396
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 25 sitesin 11 countries
- Study dates
- 30 Apr 2025to 25 May 2029
- Phase
- Phase 1
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
- 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)
Who cannot join
- Current participant or enrollment in another interventional clinical trial
- Known hypersensitivity or medical contraindication to any component of RO7673396 formulation
- Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate study treatment absorption
- Known and untreated, or active central nervous system (CNS) metastases
- Participants with chronic diarrhea, short bowel syndrome or significant upper gastrointestinal (GI) surgery including gastric resection, a history of inflammatory bowel disease (IBD)
- 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
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- Participants who are on acid-reducing agents and unable to safely discontinue them as required in the study
- 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
- 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
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Known clinically significant liver disease
Trial locations and contacts
25 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: YO45758 https://forpatients.roche.com/ contact
25 sites in 11 countries
United States6 sites, 6 recruiting
- Recruiting
UCHealth Lung Cancer Clinic - Anschutz Medical Campus - PPDS
Aurora, Colorado, 80045
- Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030-3721
- Recruiting
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, 06519-1110
- Recruiting
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, 78229-4427
- Recruiting
Florida Cancer Specialists - Sarasota (North Catttlemen Rd)
Sarasota, Florida, 34232
China4 sites, 4 recruiting
- Recruiting
Sun Yat-Sen University Cancer Center - Huangpu Campus
Guangzhou, Guangdong, 510555
- Recruiting
Sun Yat-Sen University Cancer Center;Department of Thoracic Surgery
Guangzhou, 510050
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 201315
- Recruiting
Hubei Cancer Hospital
Wuhan, 430079
Spain3 sites, 3 recruiting
- Recruiting
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
Barcelona, 08035
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Australia2 sites, 2 recruiting
- Recruiting
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010
- Recruiting
Peter MacCallum Cancer Center
Parkville, Victoria, 3052
New Zealand2 sites, 2 recruiting
- Recruiting
New Zealand Clinical Research - Auckland
Auckland, 1010
- Recruiting
New Zealand Clinical Research - Christchurch
Christchurch, 8011
Taiwan2 sites, 2 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan, 70403
- Recruiting
National Taiwan University Hospital
Taipei, 10002
United Kingdom2 sites, 2 recruiting
- Recruiting
New Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands, B15 2TH
- Recruiting
St Bartholomew's Hospital
London, EC1A 7BE
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Singapore1 site, 1 recruiting
- Recruiting
National Cancer Centre - 30 Hospital Blvd
Singapore, 168583
About this study
Official title: 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)
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.
- Conditions
- Neoplasms
- Being tested
- RO7673396
- Keywords
- RAS Mutated Solid Tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7673396Drug
RO7673396 will be administered as per the schedule specified in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Stage I | Experimental | Participants 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. Receives: Drug: RO7673396 |
| Stage II | Experimental | Participants 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. Receives: Drug: RO7673396 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage I: Number of Participants With Adverse Events (AEs)
Measured: Up to approximately 40 months
Stage I: Number of Participants With Dose-limiting Toxicities (DLTs)
Measured: 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)
Measured: Up to approximately 40 months
Secondary outcomes (4)
Plasma Concentrations of RO7673396 and its Metabolite(s)
Measured: Up to approximately 49 months
Stage I: ORR as Assessed by the Investigator per RECIST V1.1
Measured: Up to approximately 49 months
Stage I and II: Duration of Response (DOR) as Assessed by the Investigator per RECIST V1.1
Measured: Up to approximately 49 months
Stage I and II: Progression-free Survival (PFS) as Assessed by the Investigator per RECIST V1.1
Measured: Up to approximately 49 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start30 Apr 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion25 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- 405 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884618
- Sponsor's protocol ID
- YO45758
- Other IDs
- 2024-519622-20-00
- Status last verified
- Sep 2026
- First submitted
- 18 Mar 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No