Experimental drug shows promise for recurrent gynecologic cancers
NCT ID NCT06865677
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a drug called sacituzumab govitecan in people with ovarian, endometrial, or cervical cancer that returned after at least two rounds of standard treatment. The goal was to see if the drug could shrink or eliminate tumors. The study was terminated early with only 2 participants enrolled.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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2 people
The number who actually took part.
- Started
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Jun 2025
- Finished
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Jul 2025
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 120 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: Cohort 1 (Ovarian Cancer) * Participants must have histologically or cytologically confirmed recurrent platinum-resistant (defined as less than six months of platinum-free interval) epithelial (i.e., high grade serous, endometrioid, low grade serous, or clear cell) ovarian carcinoma that is refractory to standard treatment. * Participants with known BReast CAncer gene (BRCA) mutated tumors should have received a poly(ADP-ribose) polymerase (PARP) inhibitor maintenance or treatment. * Participants without known BRCA mutation and platinum-resistant tumors must have had prior bevacizumab or not eligible for bevacizumab-based therapy (i.e., history of proteinuria). Cohort 2 (Endometrial Cancer) * Participants must have histologically or cytologically confirmed recurrent epithelial (i.e., endometrioid or serous) endometrial carcinoma that is refractory to standard treatment. * Participants must have received prior anti-programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1)-based therapy or not eligible for anti-PD-1/PD-L1-based therapy. Cohort 3 (Cervical Cancer) -Participants must have histologically or cytologically confirmed recurrent epithelial cervical (i.e. squamous or adeno) carcinoma that is refractory to standard treatment. Note: Participants with a history of human papilloma virus infection (i.e., positive human papillomavirus (HPV deoxyribonucleic acid (DNA testing) are eligible. -Participants must have received prior bevacizumab-based therapy or not eligible for bevacizumab-based therapy (i.e., history of proteinuria). Note: Platinum chemotherapy administered concurrent with primary radiation (i.e., weekly cisplatin) is not counted as a systemic chemotherapeutic regimen for management of persistent or recurrent carcinoma of the cervix. All Cohorts * Participants must have received at least two systemic therapies including at least one platinum-based therapy regimen. * Participants must have radiographically measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, and safely biopsiable lesion. * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status \<= 1 * Adequate organ and marrow function as defined below: * Hemoglobin (Hgb) \>= 9.0 g/dL * Absolute neutrophil count (ANC) \>= 1,500/mcL * Platelets \>= 100,000/mcL * White Blood Cell count (WBC) \>= 3,000/mcL * Total bilirubin \<= 1.5 x upper limit of normal (ULN) (\<= 3 x ULN in participants with known/suspected Gilbert's disease) * Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) \<= 2.5 x ULN * Serum creatinine \<= 1.5 x ULN or estimated glomerular filtration rate (GFR) \>= 30 ml/min/1.73 m\^2 * Participants with suspicion or prior history of treated central nervous system (CNS) metastases with no evidence of active disease (assessed by magnetic resonance imaging (MRI) or contrast computed tomography (CT) scan of the brain and spinal column) are eligible if pretreatment brain MRI demonstrate no evidence of disease in the past 4 weeks prior to entry. * Major surgical procedure, other than for diagnosis, must not occur within 4 weeks prior to the first dose of study treatment. Participants must have recovered adequately from the toxicity and/or complications from the intervention prior to starting the study drug. * Participants with prior cancer-directed therapy must have a washout period of 3 weeks prior to the first dose of study treatment. * Participants with prior cancer-directed immunotherapy-based therapy must have a washout period of 4 weeks prior to the first dose of study treatment. * Human immunodeficiency virus (HIV)-infected participants are eligible if on stable dose of highly active antiretroviral therapy (HAART), a cluster of differentiation 4 (CD4) count \>= 200 cells/mcL, and an undetectable viral load (VL). * Hepatitis B virus (HBV) positive participants are eligible if they have been treated or are on an appropriate course of antivirals at study entry. * Participants with a history of hepatitis C virus (HCV) infection (i.e., positive HCV antibody test) must have been treated and cured (undetectable HCV VL at screening). Participants with HCV infection who are currently on treatment are eligible if they have an undetectable HCV VL. * Individuals of child-bearing potential (IOCBP) must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) prior to study entry, for the duration of study participation, and for at least 6 months after the last dose of study drug. * IOCBP must undergo pregnancy testing at screening and must not be pregnant in order to take part. Note: In these cases, a negative Beta-human chorionic gonadotropin (Beta-human chorionic gonadotropin (hCG) (urine or blood) is required. * Nursing participants must discontinue nursing and/or not begin nursing until 1 month after the last dose of study drug. * Ability of participants to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: * Participants who are receiving any other investigational agents * Primary platinum-refractory ovarian cancer (defined as progression while on the upfront platinum-based therapy) * Participants with any other concomitant invasive malignancies * History of severe hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to sacituzumab govitecan (SG), Camptosar; irinotecan; 7-ethyl-10-{4-\[1-piperidino\]-1-piperidino}carbonyoxycamptothecin (SN-38), or irinotecan. * Prior treatment with trophoblast cell-surface marker (TROP2)-targeting antibody drug conjugates (ADC). Participants with prior use of other ADCs are eligible. * Prior treatment with topoisomerase 1 inhibitors i.e., topotecan * Symptomatic or untreated brain/central nervous system (CNS) metastases * Participants who require treatment with uridine diphosphate glucuronosyltransferase (UGT1A1) inhibitors. * Participants with known homozygous UGT1A1\*28 allele if tested during the previous treatment. * Participants with active infection requiring antibiotics. * Participants who have not recovered from toxicities or adverse events (AE) related to prior therapy to Grade \<= 1 with the following exceptions. * Participants with platinum related hypomagnesemia (on replacement) are eligible. * Participants with auto-immune thyroid dysfunction on stable replacement therapy are eligible. * Participants with any grade alopecia or grade 1 or 2 neuropathy are eligible. * Participants with a history of gastrointestinal (GI) perforation or hemorrhage (\> 30mL bleeding/episode) fistula or hemoptysis within 3 months prior to initiation of study therapy, intra-abdominal abscess in the 6 months prior to entry, history of ascites or pleural effusion requiring paracentesis or thoracentesis in the 4 weeks prior to initiation of study therapy or history of bowel obstruction within 3 months prior to initiation of study therapy. * Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during SG treatment or within 5 months after the final dose of SG. Note: Seasonal flu vaccines that do not contain a live virus and locally authorized/approved Coronavirus disease 2019 (COVID-19) vaccines are permitted * Participants with severe uncontrolled intercurrent illness that would limit compliance with study requirements, evaluated by history, physical exam, and chemistry panel.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States