Closed for Enrollment

• (ECTx) GO-004; An International Phase 1/2 Study of GRT-C901/GRT-R902, a Neoantigen Cancer Vaccine, in Combination with Immune Checkpoint Blockade for Patients with Advanced Solid Tumors Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

  The purpose of this study is to evaluate the safety, dose, immunogenicity and early clinical activity of GRT-C901 and GRT-R902, a personalized neoantigen cancer vaccine, in combination with nivolumab and ipilimumab, in patients with metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, gastroesophageal adenocarcinoma, and metastatic urothelial cancer.

• ABC-108: A Phase I/IIA Study of ABC294640 Alone and in Combination with Hydroxychloroquine Sulfate in the Treatment of Patients with Advanced, Unresectable Intra-Hepatic, Perihilar and Extra-Hepatic Cholangiocarcinoma Rochester, Minn., Scottsdale/Phoenix, Ariz.

  ABC-108 is a single-arm Phase IIA clinical study of ABC294640 (Yeliva ®) in the treatment of cholangiocarcinoma (CCA). In this clinical study, all participants will be receiving ABC294640. The study drug, ABC294640 is an orally available inhibitor of the enzyme sphingosine kinase-2 (SK2). SK2 is an innovative target for anti-cancer therapy because of its critical role in sphingolipid metabolism, which is known to regulate tumor cell death and proliferation. ABC294640 also inhibits proliferation and induces apoptosis of cholangiocarcinoma cell lines. Furthermore, in a recent Phase I trial, ABC294640 demonstrated clinical activity in CCA patients. In this study, ABC294640 will be continuously administrated orally, twice a day, in 28 day cycles, until disease progression, unacceptable toxicity or voluntary withdrawal initiated by the participants or physician.

• Phase 1/2 Study of APR-246 in Combination with Pembrolizumab in Subjects with Solid Tumor Malignancies (A20-11195) Scottsdale/Phoenix, Ariz., Jacksonville, Fla., Rochester, Minn.

  The purpose of this study is to determine the safety and preliminary effectiveness of APR-246 in combination with pembrolizumab in subjects with solid tumor malignancies. The study will include a safety lead-in portion followed by a phase 2 expansion portion in specific disease groups.

• Phase I Trial of the Combination of Vismodegib GDC-0449 and Erlotinib with or without Gemcitabine Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

  The purpose of this study is to determine the side effects and best dose of erlotinib hydrochloride when given together with GDC-0449, and either with or without gemcitabine hydrochloride, for the treatment of patients who have metastatic pancreatic cancer or solid tumors that cannot be removed by surgery. Drugs used in chemotherapy, such as GDC-0449 and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving GDC-0449 together with erlotinib hydrochloride with or without gemcitabine hydrochloride may kill more tumor cells.