A Phase I, First-In-Human, Multicenter, Open-Label Dose Escalation and Dose Expansion Study of ABM-1310, as a Monotherapy and a Combination Therapy, Administered Orally in Adult Patients with Advanced Solid Tumors Harboring BRAF Mutations

The primary goal of this study is to determine the highest dose of ABM-1310 a person can take while benefiting from treatment with ABM-1310 when taken by mouth by adult patients with BRAF V600 mutated advanced solid tumors (tumors that have either spread or are no longer responding to treatment), which have progressed despite receiving the standard treatment or whose cancer does not have a standard treatment. BRAF is a gene that encodes a protein also called BRAF. This protein plays a role in cell growth by sending signals inside the cell promoting cell division. The study will have three parts, Part A where ABM-1310 will be given on its own to adult patients with BRAF V600 mutated advanced solid tumors, which have progressed despite receiving the standard treatment or whose cancer does not have a standard treatment, Part B where ABM-1310 will be given in combination with cobimetinib (Cotellic®) to adult patients who have progressed following previous combination treatment of BRAF and MEK inhibitors, and Part C where ABM-1310 will be given either on its own or in combination with cobimetinib, depending on your tumor type. In Parts A and B the dose of ABM-1310 will be increased until the highest acceptable dose is found and in Part C, that dose will be given, with or without Cobimetinib, to people with different types of cancer. This is the first study using ABM- 1310 in humans. This is an investigational study. ABM-1310 is not approved by the United States Food and Drug Administration (FDA) or commercially available. It is currently being used for clinical research purposes only. Cobimetinib is approved by the FDA, but the way it is being used in this study is not FDA approved. If you are found to be eligible to take part in this study, you will be assigned to a study group based on your previous treatment history and when you join this study.

Are you Eligible? (Inclusion Criteria)

• Must be 18 years old or older - Must have a negative pregnancy test within 72 hours before starting study treatment in all pre-menopausal women and women <12 months after the onset of menopause - Must not have a hematologic malignancy, including leukemia (any form), lymphoma, and multiple myeloma - Must not have a history of stroke ≤ 6 months prior to starting study drug