A Phase I/II Open-Label Study to Evaluate the Safety, Tolerability and Recommended Phase II Dose (RP2D) of GLG-801 in patients with Advanced Solid Tumors (Phase I); and safety, tolerability and anticancer activity of GLG-801 in patients with Metastatic TNBC (Phase II).

Primary objectives: Phase I• To evaluate safety and tolerability of escalating dose levels of GLG-801 in adult patients with advanced, refractory, solid tumors.• To determine RP2D based on MTD. Phase II• To determine the response (radiologic ORR), in patients with metastatic TNBC (based on Recist 1.1. Criteria) • To confirm the safety and tolerability of GLG-801 in patients with advanced TNBC at RP2D as determined in Phase I portion of this study.
Primary endpoints: Phase I1. Evaluation of safety and tolerability (% dropout) of escalating dose levels of GLG-8012. Determination of RP2D based on MTDPhase II1. Determination of the response (radiologic ORR), in patients with metastatic TNBC (based on Recist 1.1. Criteria) 2. Confirmation of the safety and tolerability of GLG-801 in patients with advanced TNBC, at RP2D as determined in Phase I portion of this study