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NCT Number: 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)

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO7673396

Drug

RO7673396 will be administered as per the schedule specified in the protocol.

Primary outcomes

  1. Stage I: Number of Participants With Adverse Events (AEs)

    Time frame: Up to approximately 40 months

  2. Stage I: Number of Participants With Dose-limiting Toxicities (DLTs)

    Time frame: Up to Day 21

  3. Stage II: Objective Response Rate (ORR) as Assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)

    Time frame: Up to approximately 40 months

Secondary outcomes

  1. Plasma Concentrations of RO7673396 and its Metabolite(s)

    Time frame: Up to approximately 49 months

  2. Stage I: ORR as Assessed by the Investigator per RECIST V1.1

    Time frame: Up to approximately 49 months

  3. Stage I and II: Duration of Response (DOR) as Assessed by the Investigator per RECIST V1.1

    Time frame: Up to approximately 49 months

  4. Stage I and II: Progression-free Survival (PFS) as Assessed by the Investigator per RECIST V1.1

    Time frame: Up to approximately 49 months

Study contacts

Contact information is provided by the study sponsor or research team.

Reference Study ID Number: YO45758 https://forpatients.roche.com/

CONTACT

[email protected]

888-662-6728 (U.S.)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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)

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Mar 19, 2025
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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