NCT06884618 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)
| NCT ID | NCT06884618 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Hoffmann-La Roche |
| Condition | Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 405 participants |
| Start Date | 2025-04-30 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 405 participants in total. It began in 2025-04-30 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
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 ≥12 weeks * Adequate hematologic and end-organ function * Confirmed presence of the RAS mutation(s) Exclusion Criteria: * 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 * 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 * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures * Known clinically significant liver disease
Contact & Investigator
Reference Study ID Number: YO45758 https://forpatients.roche.com/
✉ global-roche-genentech-trials@gene.com📞 888-662-6728 (U.S.)
Clinical Trials
STUDY DIRECTOR
Hoffmann-La Roche
Frequently Asked Questions
Who can join the NCT06884618 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06884618 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06884618 currently recruiting?
Yes, NCT06884618 is actively recruiting participants. Contact the research team at global-roche-genentech-trials@gene.com for enrollment information.
Where is the NCT06884618 trial being conducted?
This trial is being conducted at Duarte, United States, Aurora, United States, New Haven, United States, Sarasota, United States and 11 additional locations.
Who is sponsoring the NCT06884618 clinical trial?
NCT06884618 is sponsored by Hoffmann-La Roche. The principal investigator is Clinical Trials at Hoffmann-La Roche. The trial plans to enroll 405 participants.