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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)

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 21 → 25 locations Eligibility criteria expanded, about 44 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 44 words
  2. Enrollment increased: 345 → 405 participants Eligibility criteria expanded, about 18 wordsv15 Show 1 more changeShow less
    • Eligibility criteria expanded, about 18 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 19 to 21v14
  4. Re-verified, no change to tracked fieldsv13
  5. Study sites revised (19)v12 See this version in full on ClinicalTrials.gov ↗
Show 10 earlier versionsHide 10 earlier versions
  1. Re-verified, no change to tracked fieldsv11
  2. Study sites: 18 to 19v10
  3. Re-verified, no change to tracked fieldsv9
  4. Study sites: 12 to 18v8
  5. Study sites: 7 to 12v7
  6. Study sites: 5 to 7v6
  7. Study sites: 3 to 5v5
  8. Study sites: 2 to 3v4
  9. Re-verified, no change to tracked fieldsv3
  10. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2v2 Show 1 more changeShow less
    • Study sites: 0 to 2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Roche/Genentech
366 trials monitored
See 33 trials at risk
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.
Trial Details
NCT Number NCT06884618
Lead Sponsor Hoffmann-La Roche
Conditions Neoplasms
Enrollment 405 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov