deltatrials
Active Not Recruiting PHASE1/PHASE2 INTERVENTIONAL 2-arm NCT04616183

LY3214996 and Cetuximab Alone or in Combination With Abemaciclib for the Treatment of Unresectable or Metastatic Colorectal Cancer

Open-Label Phase 1b/2 Study of Cetuximab Administered in Combination With LY3214996 (ERK 1/2 Inhibitor) or Cetuximab in Combination With LY3214996 and Abemaciclib in Patients With Metastatic, Anti-EGFR-Refractory Colorectal Cancer

Sponsor: M.D. Anderson Cancer Center

Conditions Metastatic Colon Adenocarcinoma Metastatic Colorectal Carcinoma Metastatic Rectal Adenocarcinoma Recurrent Colorectal Carcinoma Stage III Colon Cancer AJCC v8 Stage III Colorectal Cancer AJCC v8 Stage III Rectal Cancer AJCC v8 Stage IIIA Colon Cancer AJCC v8 Stage IIIA Colorectal Cancer AJCC v8 Stage IIIA Rectal Cancer AJCC v8 Stage IIIB Colon Cancer AJCC v8 Stage IIIB Colorectal Cancer AJCC v8 Stage IIIB Rectal Cancer AJCC v8 Stage IIIC Colon Cancer AJCC v8 Stage IIIC Colorectal Cancer AJCC v8 Stage IIIC Rectal Cancer AJCC v8 Stage IV Colon Cancer AJCC v8 Stage IV Colorectal Cancer AJCC v8 Stage IV Rectal Cancer AJCC v8 Stage IVA Colon Cancer AJCC v8 Stage IVA Colorectal Cancer AJCC v8 Stage IVA Rectal Cancer AJCC v8 Stage IVB Colon Cancer AJCC v8 Stage IVB Colorectal Cancer AJCC v8 Stage IVB Rectal Cancer AJCC v8 Stage IVC Colon Cancer AJCC v8 Stage IVC Colorectal Cancer AJCC v8 Stage IVC Rectal Cancer AJCC v8 Unresectable Colon Adenocarcinoma Unresectable Colorectal Carcinoma Unresectable Rectal Adenocarcinoma
Interventions Abemaciclib Cetuximab ERK1/2 Inhibitor LY3214996
Updated 16 times since 2020 Last updated: Dec 22, 2025 Started: Dec 2, 2020 Primary completion: Dec 31, 2028 Completion: Dec 31, 2028
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04616183, this PHASE1/PHASE2 trial focuses on Metastatic Colon Adenocarcinoma and Metastatic Colorectal Carcinoma and remains ongoing. Sponsored by M.D. Anderson Cancer Center, it has been updated 16 times since 2020, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Feb 2022 · 13 months · monthly snapshot~Feb 2022 – ~Apr 2023 · 14 months · monthly snapshot~Apr 2023 – ~Sep 2023 · 5 months · monthly snapshot~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Feb 2024 · 3 months · monthly snapshot~Feb 2024 – ~Apr 2024 · 2 months · monthly snapshot~Apr 2024 – ~Jun 2024 · 2 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshot~Nov 2024 – ~May 2025 · 6 months · monthly snapshot~May 2025 – ~Nov 2025 · 6 months · monthly snapshot~Nov 2025 – ~Jan 2026 · 2 months · monthly snapshot~Jan 2026 – present · 8 months · monthly snapshot

Change History

16 versions recorded

  1. Jan 2026 — Present [monthly]

    Active Not Recruiting PHASE1/PHASE2

  2. Nov 2025 — Jan 2026 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  3. May 2025 — Nov 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  4. Nov 2024 — May 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  5. Sep 2024 — Nov 2024 [monthly]

    Active Not Recruiting PHASE1/PHASE2

▶ Show 11 earlier versions

  1. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  2. Jun 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  3. Apr 2024 — Jun 2024 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  4. Feb 2024 — Apr 2024 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  5. Nov 2023 — Feb 2024 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: Recruiting → Active Not Recruiting

  6. Oct 2023 — Nov 2023 [monthly]

    Recruiting PHASE1_PHASE2

  7. Sep 2023 — Oct 2023 [monthly]

    Recruiting PHASE1_PHASE2

  8. Apr 2023 — Sep 2023 [monthly]

    Recruiting PHASE1_PHASE2

  9. Feb 2022 — Apr 2023 [monthly]

    Recruiting PHASE1_PHASE2

  10. Jan 2021 — Feb 2022 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Not Yet Recruiting → Recruiting

  11. Dec 2020 — Jan 2021 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)
Data source: M.D. Anderson Cancer Center

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations