Treating Advanced or Metastatic Cancers with a New PARP1 Inhibitor (GS-0201) Alone or Combined with Other Drugs
Treatment
Treatment study for people with advanced or metastatic solid tumors
Clinicaltrials.gov identifier:NCT06167317
Study Contact Information:
Name: Gilead Clinical Study Information Center
Phone Number: 1-833-445-3230 (GILEAD-0)
Email: GileadClinicalTrials@gilead.com
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 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 known as a PARP1 inhibitor.
This Study is Open To:
People with advanced or 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 .
This Study is NOT Open To:
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.
- or chemotherapy less than 2 weeks before starting treatment.
- 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.
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 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.
Study Contact Information:
Name: Gilead Clinical Study Information Center
Phone Number: 1-833-445-3230 (GILEAD-0)
Email: GileadClinicalTrials@gilead.com
Locations:
Massachusetts
City: Boston RECRUITING
Facility: Dana-Farber Cancer Institute
Contact Info:
No contact info provided
Texas
City: Austin RECRUITING
Facility: NEXT Austin
Contact Info:
No contact info provided
City: Houston RECRUITING
Facility: The University of Texas MD Anderson Cancer Center
Contact Info:
No contact info provided
City: Irving RECRUITING
Facility: NEXT Dallas
Contact Info:
No contact info provided
Other Countries
Country: Israel
City: Haifa RECRUITING
Facility: Rambam Health Care Campus
Contact Info:
No contact info provided
Country: Israel
City: Tel Aviv RECRUITING
Facility: Tel Aviv Sourasky Medical Center
Contact Info:
No contact info provided
Country: Israel
City: Tel Hashomer RECRUITING
Facility: Chaim Sheba Medical Center
Contact Info:
No contact info provided
Treatment
Treatment study for people with advanced or metastatic solid tumors
Clinicaltrials.gov identifier:NCT06167317
Study Contact Information:
Name: Gilead Clinical Study Information Center
Phone Number: 1-833-445-3230 (GILEAD-0)
Email: GileadClinicalTrials@gilead.com