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. Participants who have received prior treatment with a may still be eligible for Parts A or C of the study..
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 .
Partients who have received prior treatment with a may still be eligible for Parts A or C of the study.
Patients with stable brain or spinal cord may still be eligible if they have all of the following:
- stable CNS disease for at least 4 weeks prior to enrollment.
- all neurologic symptoms have returned to baseline.
- there is no evidence of new or enlarging brain metastases.
- they have been on a dose of prednisone (≤10 mg/day) or equivalent for at least 4 weeks prior.
- CNS disease cannot be their only site of measurable .
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 that is not stable.
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 will receive GS-0201 orally either alone or in combination with sacituzumab govitecan (Trodelvy), administered 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