A Phase IB Study of LY3039478 plus Other Anticancer Therapies in Patients with Advanced Solid Tumors

Full Title

I6F-MC-JJCD(a): A Phase 1b Study of LY3039478 in Combination with Other Anticancer Agents in Patients with Advanced or Metastatic Solid Tumors


The purpose of this study is to assess the safety of the investigational drug LY3039478 in combination with five other anticancer drugs in patients with inoperable and metastatic solid tumors that continue to grow despite prior treatment. LY3039478 works against cancer by inhibiting the NOTCH signaling pathway, which some cancers use to grow. In this study, patients will receive LY3039478 plus one of these other drugs:

  • LY2940680, an investigational drug that blocks another signaling pathway involved in cancer called the hedgehog pathway.
  • LY3023414, an investigational drug that inhibits a signaling pathway called PI3 kinase/mTOR.
  • LY2835219, an investigational drug which interferes with the CDK4/6 pathway.
  • Cisplatin and gemcitabine, which are FDA-approved chemotherapy drugs used to treat other cancers.
  • Carboplatin and gemcitabine, chemotherapy drugs used to treat other cancers.

LY3039478, LY2940680, LY3023414, and LY2835219 are taken orally (by mouth). Cisplatin, gemcitabine, and carboplatin are given intravenously (by vein).


To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have an inoperable or metastatic solid tumor that has continued to grow despite prior therapy. The various study groups will include patients with soft tissue sarcoma, breast cancer, colon cancer, and bile duct cancer (cholangiocarcinoma).
  • Patients must recover from the serious side effects of previous therapies before entering the study.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. William Tap at 636-888-4163.