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Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 1 of 3 entries Trial sites expanded: 27 → 49 locations · Interventions: Cetuximab (Drug), FOLFIRI (Drug), FOLFOX6/FOLFOX7 (Drug), Gemcitabine (Drug), Nab-paclitaxel (Drug), Panitumumab (Drug), S241656 (Drug) to Cetuximab (Drug), FOLFIRI (Drug), FOLFOX6/FOLFOX7 (Drug), Gemcitabine (Drug), Nab-paclitaxel (Drug), Panitumumab (Drug), S241656 (Drug) · Eligibility criteria expanded, about 31 words · 1 more Show 4 more changesShow less
    • Trial sites expanded: 27 → 49 locations
    • Interventions: Cetuximab (Drug), FOLFIRI (Drug), FOLFOX6/FOLFOX7 (Drug), Gemcitabine (Drug), Nab-paclitaxel (Drug), Panitumumab (Drug), S241656 (Drug) to Cetuximab (Drug), FOLFIRI (Drug), FOLFOX6/FOLFOX7 (Drug), Gemcitabine (Drug), Nab-paclitaxel (Drug), Panitumumab (Drug), S241656 (Drug)
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: details revised at 15 of 17 entries
  2. Trial sites expanded: 11 → 27 locationsv23
  3. Study sites: 10 to 11v22
  4. Site contacts updated at 1 of 10 sitesv21
  5. Phase: Phase 1 to Phase 1/2 Enrollment target: 100 to 554 · Primary completion date: Jun 2026 to Jun 2028 · Primary endpoints: 5 to 3 · 7 morev20 Show 10 more changesShow less
    • Enrollment target: 100 to 554
    • Primary completion date: Jun 2026 to Jun 2028
    • Primary endpoints: 5 to 3
    • Completion date: Dec 2026 to Jun 2028
    • Interventions: BDTX-4933 (Drug) to Cetuximab (Drug), FOLFIRI (Drug), FOLFOX6/FOLFOX7 (Drug), Gemcitabine (Drug), Nab-paclitaxel (Drug), Panitumumab (Drug), S241656 (Drug)
    • Eligibility criteria shortened, about 36 words
    • Secondary endpoints: 10 to 17
    • Site details revised at 2 of 10 sites
    • Study arms: 2 to 16
    • Study title shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

Show 18 earlier versionsHide 18 earlier versions
  1. Lead sponsor: Black Diamond Therapeutics, Inc. to Institut de Recherches Internationales Servier Trial status: Active, Not Recruiting to Recruiting · Site details revised at 10 of 10 sitesv19 Show 2 more changesShow less
    • Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 10 of 10 sites
  2. Study sites: 14 to 10v18
  3. Trial status: Recruiting to Active, Not Recruiting Site details revised at 14 of 14 sitesv17 Show 1 more changeShow less
    • Site details revised at 14 of 14 sites
  4. Study sites: 12 to 14v16
  5. Study sites: 10 to 12 Eligibility criteria expanded, about 47 wordsv15 Show 1 more changeShow less
    • Eligibility criteria expanded, about 47 words

    See this version in full on ClinicalTrials.gov ↗

  6. Study sites: 9 to 10v14
  7. Study sites: 8 to 9v13
  8. Site contacts updated at 1 of 8 sitesv12
  9. Study sites: 7 to 8v11
  10. Primary endpoints: 1 to 5 Enrollment target: 140 to 100 · Eligibility criteria shortened, about 56 words · Secondary endpoints revised (10) · 1 morev10 Show 4 more changesShow less
    • Enrollment target: 140 to 100
    • Eligibility criteria shortened, about 56 words
    • Secondary endpoints revised (10)
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  11. Re-verified, no change to tracked fieldsv9
  12. Study sites: 6 to 7v8
  13. Re-verified, no change to tracked fieldsv7
  14. Study sites: 5 to 6v6
  15. Study sites: 2 to 5v5
  16. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Jun 2023 to Apr 18, 2023v4 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Jun 2023 to Apr 18, 2023
  17. Study Status, Eligibilityv3
  18. Primary endpoint revised Study title shortened, about 3 wordsv2 Show 1 more changeShow less
    • Study title shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  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.
BDTX-4933-101 is a first-in-human, open-label, Phase 1/2 dose escalation, dose optimization and expansion study designed to evaluate the safety and tolerability of S241656 as monotherapy and in combination with other anti-cancer therapies in participants with selected advanced malignancies. The study population for the Dose Escalation part of the study comprises adults with recurrent advanced/metastatic non-small cell lung cancer (NSCLC), Gastrointestinal (GI) cancers, and other solid tumors harboring KRAS, HRAS, NRAS, BRAF, and/or CRAF (Rapidly Accelerated Fibrosarcoma (RAF1)) mutations or alterations. A dose optimization part in adults with NSCLC may follow the dose escalation phase if the sponsor, in consultation with the safety review committee, decides it is necessary to further characterize the optimal dose. However, the study may also proceed directly to the expansion phase. The study population for the Dose Expansion part of the study comprises adults with advanced/metastatic NSCLC with KRAS and/or BRAF mutations, and with Pancreatic Ductal AdenoCarcinoma (PDAC), ColoRectal Cancer (CRC), and Biliary Tract Cancer (BTC) with KRAS, HRAS, NRAS, BRAF, and/or CRAF (RAF1) mutations and alterations. All patients will self-administer S241656 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.
Trial Details
NCT Number NCT05786924
Lead Sponsor Institut de Recherches Internationales Servier
Conditions Non-small Cell Lung Cancer, Histiocytic Neoplasm, Histiocytosis, BRAF Gene Mutation, BRAF V600E, BRAF V600 Mutation, BRAF Mutation-Related Tumors, BRAF +24 more
Enrollment 554 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov