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NCT04616183

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

Active, enrolled Phase 1, PHASE2 Last updated 23 December 2025
What this trial tests

Phase 1, PHASE2 trial testing Abemaciclib in Metastatic Colon Adenocarcinoma in 46 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
2 December 2020
Primary endpoint
31 December 2028
31 December 2028

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 1, PHASE2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment46
Start date2 December 2020
Primary completion31 December 2028
Estimated completion31 December 2028
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Metastatic Colon Adenocarcinoma or Metastatic Colorectal Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase Ib/II trial investigates the side effects and best dose of LY3214996 when given together with cetuximab alone or in combination with abemaciclib and to see how well they work in treating patients with colorectal cancer that cannot be removed by surgery (unresectable) and/or has spread to other places in the body (metastatic). Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. LY3214996 and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving LY3214996 and cetuximab alone or in combination with abemaciclib may help treat patients with colorectal cancer.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting RAS-RAF-MEK-ERK signaling pathway in human cancer: Current status in clinical trials.
    Song Y, Bi Z, Liu Y, Qin F, et al · · 2023 · cited 129× · PMID 37013062 · DOI 10.1016/j.gendis.2022.05.006
  2. Small molecule inhibitors targeting the cancers.
    Liu GH, Chen T, Zhang X, Ma XL, et al · · 2022 · cited 127× · PMID 36254250 · DOI 10.1002/mco2.181
  3. Oncogenic KRAS blockade therapy: renewed enthusiasm and persistent challenges.
    Tang D, Kroemer G, Kang R. · · 2021 · cited 65× · PMID 34607583 · DOI 10.1186/s12943-021-01422-7
  4. Inhibitors of Cyclin-Dependent Kinases: Types and Their Mechanism of Action.
    Łukasik P, Baranowska-Bosiacka I, Kulczycka K, Gutowska I. · · 2021 · cited 58× · PMID 33802080 · DOI 10.3390/ijms22062806
  5. Cyclin-Dependent Kinase Inhibitors and Their Therapeutic Potential in Colorectal Cancer Treatment.
    Thoma OM, Neurath MF, Waldner MJ. · · 2021 · cited 45× · PMID 35002699 · DOI 10.3389/fphar.2021.757120
  6. The Role of PIM Kinases in Pediatric Solid Tumors.
    Julson JR, Marayati R, Beierle EA, Stafman LL. · · 2022 · cited 5× · PMID 35892829 · DOI 10.3390/cancers14153565
  7. Colorectal cancer pathogenesis, oncogenic signaling networks and targeted therapeutic advances.
    Chen Y, Zhang J, Ding Y, Zhu F, et al · · 2026 · PMID 41826571 · DOI 10.1186/s43556-026-00433-4

Verify or expand the search:

Other trials of Abemaciclib

Trials testing the same drug.

Other recruiting trials for Metastatic Colon Adenocarcinoma

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04616183.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing