Background:
Cancers of the female reproductive organs often come back after treatment. A drug called
sacituzumab govitecan (SG) has been approved for use in other types of cancers.
Researchers want to see if SG can also help people with ovarian, endometrial, or cervical
cancers.
Objective:
To test SG in people with ovarian, endometrial, or cervical cancers.
Eligibility:
People aged 18 years and older with ovarian, endometrial, or cervical cancer. Their
cancers must have returned after at least 2 rounds of standard treatments.
Design:
Participants will be screened. They will have a physical exam with blood and urine tests.
They will have imaging scans and a test of their heart function. They also will have
biopsies to get new tissues samples taken from their tumors.
SG is infused through a tube attached to a needle inserted into a vein in the arm.
Treatment will be given in 21-day cycles. Participants will receive SG on days 1 and 8 of
each cycle. Each infusion takes 1 to 3 hours.
Participants may receive SG for up to 5 years. They can continue as long as the drug is
helping them. Imaging scans and other tests will be repeated throughout the study period.
Participants will have an end-of-treatment visit within 2 weeks and a safety visit about
30 days after they stop treatment. Physical exams, blood tests, and imaging scans may be
repeated.
Participants will then be contacted by phone every 6 months for up to 10 years after
their first dose of SG.
Sponsoring Institution:
National Cancer Institute...
Additional locations may be listed on ClinicalTrials.gov for NCT06865677.
Locations matching your search criteria
United States
Maryland
Bethesda
National Institutes of Health Clinical CenterStatus: Active
Contact: National Cancer Institute Referral Office
Phone: 888-624-1937
Background:
- Human trophoblast cell-surface marker (TROP2) is a surface glycoprotein originally
identified in human placental tissue and highly expressed in gynecologic
malignancies. TROP2 overexpression in ovarian, endometrial, and cervical cancers is
linked to tumorigenicity and poor overall survival.
- Sacituzumab govitecan (SG) is an antibody-drug conjugate (ADC) of an IgG(kappa)1
monoclonal antibody targeting TROP2 with a chemotherapeutic payload of SN-38. SN-38
is an active metabolite of irinotecan and acts as a topoisomerase I inhibitor.
- Preclinical data suggest that SG induces DNA damage, replication stress, and tumor
shrinkage in drug-resistant ovarian, endometrial, and cervical cancer in vitro and
in vivo preclinical models.
- Further clinical and translational studies are needed to better understand SG s
clinical activity and biology in relapsed gynecologic cancer patients.
Objective:
-To determine the objective response rate (ORR) of sacituzumab govitecan (SG) in
participants with recurrent gynecological malignancies, calculated for each individual
tumor histology by RECIST v1.1.
Eligibility:
- Age >= 18 years
- ECOG performance status <= 1
- Histologically documented, recurrent platinum-resistant epithelial ovarian, primary
peritoneal, or fallopian tube cancer (referred to as ovarian cancer); recurrent
endometrioid or serous endometrial cancer; or recurrent epithelial cervical cancer
- At least two prior systemic therapeutic regimens
- Measurable disease by RECIST v1.1 criteria with lesions that can be safely biopsied
- No prior TROP2-targeting ADC
Design:
- This is an open label, non-randomized Phase II pilot study with one Arm.
- SG will be administered intravenously (IV) at 10 mg/kg on Days 1 and 8 each 21-day
cycle.
- Tumor assessments will be time-based: every 9 weeks (+/- 1 week) for the first year
and every 12 weeks (+/- 1 week) thereafter until disease progression. Pre-treatment
biopsies and serial blood samples will be collected for the correlative studies.
- Treatment will be given for a maximum of 5 years or until disease progression or
unacceptable toxicities.
- Up to 66 evaluable participants will be enrolled.
Lead OrganizationNational Cancer Institute
Principal InvestigatorJung-min Lee