A Phase 1b Study of ABBV-637 or ABBV-155 With ERAS-801 or Standard Therapy for People With Glioblastoma

Full Title

Purpose

This study is assessing ABBV-637 and ABBV-155 with ERAS-801 or standard treatment in people with glioblastoma. The people in this study have newly diagnosed glioblastoma or glioblastoma that returned after treatment and can be surgically removed. In addition, their tumors have a mutation (change) in the EGFR gene.

ABBV-637 and ABBV-155 are called antibody-drug conjugates. The antibody binds to a protein on cancer cells and the drug is released to kill the cells. ABBV-637 targets the EGFR gene and ABBV-155 targets a gene called B7H3. They may help slow or stop the growth of your cancer. They are both given intravenously (by vein).

ERAS-801 blocks the EGFR protein, which promotes cell growth. By blocking the EGFR protein, ERAS-801 may stop cancer growth and spread. It is taken orally (by mouth).

People with recurrent glioblastoma will get one of these treatments:

• ABBV-637 before standard surgery, followed by ABBV-637 and ERAS-801 after surgery.
• ABBV-155 before standard surgery, followed by ABBV-155 and ERAS-801 after surgery.

People with newly diagnosed glioblastoma will get one of these therapies:

• ABBV-637 plus standard radiation therapy and the chemotherapy drug temozolomide, which is taken orally.
• ABBV-155 plus standard radiation and temozolomide.

Who Can Join

To join this study, there are a few conditions. You must:

• Have newly diagnosed glioblastoma OR
• Have recurrent glioblastoma that has not been treated with more than 2 regimens of therapy and can be surgically removed.
• Have glioblastoma with an EGFR mutation.
• Have recovered from the serious side effects of prior anti-cancer therapies before getting the study treatment.
• Be able to walk and do routine activities for more than half the time you are awake.
• Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Thomas Kaley’s office at 212-639-5122.