Treating Advanced or Metastatic Cancers with a New PARP1 Inhibitor (GS-0201) Alone or Combined with Other Drugs

About the Study

The goal of this treatment study is to learn if the new drug GS-0201 is safe and can help treat people with different types of metastatic or advanced cancer. GS-0201 is a new drug that has not yet been approved for treatment of cancer. GS-0201 is a type of targeted therapy known as a PARP1 inhibitor. 

What the Study Involves

The study is usually divided into different “parts” or “groups.” Some groups receive GS-0201 orally by itself, while others receive GS-0201 with the injectable medication sacituzumab govitecan (Trodelvy).

The study has several steps:

• Screening: Researchers check if participants fit the rules of the study (eligibility criteria).
• Treatment: Eligible participants receive GS-0201 orally. Participants with metastatic breast cancer will receive GS-0201 orally and the drug sacituzumab govitecan (Trodelvy) intravenously. 
• Monitoring: Participants will be regularly checked for side effects, how their cancer responds, and other health changes. 
• Follow-Up: Even after treatment ends, researchers will keep in touch to see how participants are doing.

People with advanced or metastatic cancer may be eligible. Participants must no longer have treatment options known to benefit people with their type of cancer.

• All participants must have adequate liver and kidney function.

Additional eligibility may depend on which study group people are enrolled in.

• Some participants may be required to undergo additional biopsies. 
• Some participants may need to test positive for specific biomarkers.
• Participants with breast cancer must be HER2-negative. 

People cannot participate if they:

• received any of the following treatments below within the specified time frame:
  • major surgery less than 4 weeks before staring treatment. 
  • targeted therapy or chemotherapy less than 2 weeks before starting treatment.  
  • immunotherapy or biologic therapy less than 3 weeks before starting treatment. 
  • other experimental therapy less than 3 weeks before starting treatment.
  • radiation less than 2 weeks before starting treatment, and the radiation must not be for the primary tumor being followed. 
  • any prior allogeneic tissue/solid organ transplantation, including allogeneic hematopoietic stem cell transplantation. Participants with a history of autologous hematopoietic stem cell transplantation are also excluded.
• have spread of cancer to brain or spinal cord.