Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04855656 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Study of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors

Study acronym: MYTHIC
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 24 words
    • Secondary endpoints: details revised at 4 of 6 entries
    • Site details revised at 1 of 26 sites
    • Study description expanded, about 3 words
  2. Trial sites expanded: 22 → 26 locationsv21
  3. 3 versions Re-verified since May 26, 2026, no change to tracked fieldsv18-v20
  4. Study description expanded, about 20 wordsv17
  5. Site details revised at 1 of 22 sitesv16
Show 14 earlier versionsHide 14 earlier versions
  1. Site details revised at 1 of 22 sitesv15
  2. Lead sponsor: Repare Therapeutics to Debiopharm International SAv14 Show 10 more changesShow less
    • Primary completion date: Jun 30, 2026 to Dec 2027
    • Primary endpoints revised (6)
    • Enrollment target: 364 to 464
    • Study completion date: Dec 31, 2026 to Jun 2028
    • Interventions: Debio0123 (Drug), RP-3500 (Drug), RP-6306 (Drug) to Debio0123 (Drug), Lunresertib (Drug), RP-3500 (Drug)
    • Eligibility criteria revised
    • Secondary endpoints revised (6)
    • Study description expanded, about 21 words
    • Study title revised
    • Collaborators shortened, about 3 words
  3. Study sites: 20 to 22v13
  4. Study sites: 14 to 20v12
  5. Enrollment target: 180 to 364v11 Show 9 more changesShow less
    • Primary endpoints: 4 to 6
    • Study sites: 12 to 14
    • Interventions: RP-3500 (Drug), RP-6306 (Drug) to Debio0123 (Drug), RP-3500 (Drug), RP-6306 (Drug)
    • Eligibility criteria expanded, about 73 words
    • Secondary endpoints: 5 to 6
    • Study description expanded, about 18 words
    • Study arms: 2 to 3
    • Collaborators expanded, about 3 words
    • Study title expanded, about 3 words
  6. Primary completion date: Oct 30, 2023 to Jun 30, 2026
    • Study completion date: Dec 31, 2024 to Dec 31, 2026
    v10
  7. Re-verified, no change to tracked fieldsv9
  8. Enrollment target: 120 to 180
    • Study completion date: Apr 30, 2024 to Dec 31, 2024
    • Site contacts updated at 1 of 12 sites
    v8
  9. Enrollment target: 60 to 120v7 Show 10 more changesShow less
    • Primary completion date: Apr 2023 to Oct 30, 2023
    • Primary endpoints: 2 to 4
    • Study sites: 9 to 12
    • Study completion date: Jun 2023 to Apr 30, 2024
    • Start date: Apr 23, 2021 to Apr 30, 2021
    • Interventions: RP-6306 (Drug) to RP-3500 (Drug), RP-6306 (Drug)
    • Secondary endpoints: 3 to 5
    • Study description expanded, about 16 words
    • Study title expanded, about 8 words
    • Study arms: 1 to 2
  10. Study sites: 6 to 9v6
  11. Study sites: 5 to 6v5
  12. Study sites: 1 to 5v4
  13. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 2021 to Apr 23, 2021
    • Site details revised
    v3
  14. Study sites: 0 to 1v2
  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.
The primary purpose of this study is to assess the safety and tolerability of lunresertib alone and in combination with RP-3500 or in combination with Debio 0123 in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) and assess preliminary anti-tumor activity.
Trial Details
NCT Number NCT04855656
Lead Sponsor Debiopharm International SA
Conditions
(from sponsor)		 Advanced Solid Tumor
Enrollment 464 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov