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Sacituzumab Govitecan and Cisplatin for Recurrent Ovarian and Endometrial Cancer

This study is testing a combination of two drugs, Sacituzumab Govitecan and Cisplatin, for women with recurrent ovarian or endometrial cancer that is sensitive to platinum-based chemotherapy. Researchers want to find the best dose of Sacituzumab Govitecan to use with Cisplatin. They will be looking at how safe the combination is and how well it shrinks tumors. To join, you must be an adult woman (18 years or older) with a confirmed diagnosis of epithelial ovarian or endometrial cancer that has returned and shows up on imaging scans. The study is currently recruiting participants.

Study design
This is an open-label, Phase 1 study with a dose expansion cohort, meaning all participants and doctors will know which treatments are being given. It aims to enroll 54 participants across two disease groups (ovarian and endometrial cancer).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how well the treatment works every 3 cycles (each cycle is 21 days).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06040970

Sacituzumab Govitecan in Combination With Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Icahn School of Medicine at Mount Sinai
~54 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:SacituzumabCisplatin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-limiting toxicity (DLT) at the maximum tolerated dose (MTD) for the Safety Run-In Phase
Measured over within the first cycle of therapy (each cycle = 21 days)
+2 more outcomes measured

Conditions

Ovarian Cancer
Malignant Neoplasm of Uterus

Explore related trials

Endometrial CarcinomaMalignant Ovarian Neoplasm

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Amy Tiersten, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai Division of Hematology and Medical Oncology

Who to contact

Amy Tiersten, MD
[email protected]
(212) 241-3300
Email the study team

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Eligibility criteria

Inclusion

Pathologic (histology or cytology) confirmed diagnosis of epithelial ovarian cancer or endometrial cancer
Radiographic evidence of recurrent epithelial ovarian cancer (ovarian, fallopian tube, or primary peritoneal cancer) or endometrial cancer that is "platinum-sensitive," defined as progression of disease beyond 6 months from the last dose of platinum-based chemotherapy
Female, age ≥ 18 years
World Health Organization (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
Patient has measurable disease (at least one lesion that can be accurately assessed repeatedly by CT) as evidenced on pre-treatment baseline CT of Chest/Abdomen/Pelvis or PET/CT, or evaluable disease
Adequate hematologic counts, as defined below, without transfusion or growth factor support within 2 weeks of study drug initiation:
Hemoglobin ≥ 8.5 g/dL
Absolute neutrophil count ≥ 1500/mm3
Platelets ≥ 100,000/μL
Adequate organ function as defined below:
Total bilirubin ≤ 1.5 ULN
AST(SGOT)/ALT(SPGT) ≤ 2.5x ULN or ≤ 5 x ULN if known liver metastases
Serum albumin \> 3 g/dL
Creatinine clearance ≥ 50 mL/min per the Cockcroft-Gault equation
Women of childbearing potential must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Has not undergone a hysterectomy or bilateral oophorectomy; or
Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
Ability to understand and the willingness to sign a written informed consent.

Exclusion

Any investigational agents or study drugs from a previous clinical study within 28 days or 5 half-lives (whichever is longer) of the first dose of study treatment
Any other chemotherapy, immunotherapy or anticancer agents within 14 days of the first dose of study treatment
Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment
Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment
With the exception of alopecia, any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment
As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, or uncontrolled infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
Known or severe (Grade 3 or higher) hypersensitivity to SG and/or cisplatin, their metabolites, or formulation excipients
Peripheral neuropathy grade 2 or greater
Refractory nausea and vomiting, chronic gastrointestinal diseases
Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Women of childbearing potential unwilling to use effective contraception during study until conclusion of 6-month post-treatment evaluation period
Known history of unstable angina, MI, or CHF present within 6 months of randomization or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy
Known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months of enrollment.
Prior history of clinically significant bleeding, intestinal obstruction, or GI perforation within 6 months of enrollment.
Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
Prior therapy with sacituzumab govitecan, irinotecan, Trop-2-directed antibody drug conjugate, or any topoisomerase I-containing antibody-drug conjugates at any time for early stage disease
Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of enrollment.
Requirement for ongoing therapy with any prohibited medications
Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they have stable CNS disease for ≥ 4 weeks prior to randomization and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking 10 mg/day or less of prednisone or its equivalent. All participants with carcinomatous meningitis are excluded regardless of clinical stability.
Have an active second malignancy. Participants with a history of malignancy that have been completely treated, with no evidence of active cancer for 3 years prior to randomization, or participants with surgically cured tumors with low risk of recurrence (e.g., nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar) are allowed to enroll.
Use of any live vaccine against infectious diseases within 30 days of the first dose of study drugs.
Have an active serious infection requiring systemic antimicrobial therapy

What this trial measures

  • Dose-limiting toxicity (DLT) at the maximum tolerated dose (MTD) for the Safety Run-In Phasewithin the first cycle of therapy (each cycle = 21 days)

    Safety Run-In Phase: The primary endpoint of the safety run-in phase is to determine DLT and the recommended DEC dose of sacituzumab govitecan in combination with a fixed schedule of cisplatin in patients with ovarian and endometrial cancers. DLT is defined as any therapy-attributable adverse event (AE) requiring discontinuation of therapy within one cycle of combined therapy; specifically grade 3 or 4 non-hematologic toxicity and grade 4 hematologic toxicity events. These will be assessed via NCI's CTCAE v 5.0 toxicity criteria. DEC dose is defined as the highest dose at which no more than 1 out of 6 patients experience a DLT. All primary endpoints will be reported separately for each of the ovarian and endometrial cohorts.

  • Dose limiting toxicity (DLT) for the DEC Phasewithin 1 cycle of therapy (each cycle = 21 days)

    A primary endpoint for the dose expansion cohort (DEC) phase of this study will be the DLT rate evaluated within 1 cycle of sacituzumab in combination with cisplatin. The DLT rate is defined as the proportion of patients in the safety population of the phase 1 and dose expansion cohort (DEC) phase of the study that experience at least 1 DLT within the first cycle of sacituzumab in combination with cisplatin treated at the maximum tolerated dose (MTD). DLT is defined as any therapy-attributable adverse event (AE) requiring discontinuation of therapy within one cycle of combined therapy; specifically grade 3 or 4 non-hematologic toxicity and grade 4 hematologic toxicity events. These will be assessed via NCI's CTCAE v 5.0 toxicity criteria. All primary endpoints will be reported separately for each of the ovarian and endometrial cohorts.

  • Overall Response Rate (ORR)every 3 cycles (each cycle is 21 days)

    A primary endpoint for the dose expansion cohort (DEC) phase will be the ORR evaluated within 3 cycles of sacituzumab in combination with cisplatin in patients with platinum-sensitive recurrent epithelial ovarian cancer and endometrial cancer. This will be measured every 3 cycles (12 weeks +/- 1 week). The overall response rate is defined as the proportion of patients in the full analysis (FA) population treated at the MTD, in both the phase 1 and DEC phases of the study, whose cancer decreases in size on assessment (as measured by the sum of complete response (CR) and partial response (PR)). Disease status will be assessed based on RECIST 1.1 criteria for measurable and non-measurable disease. The Full Analysis (FA) population includes all patients who received at least one cycle of all study medications and had at least one valid post-baseline efficacy assessment. All primary endpoints will be reported separately for each of the ovarian and endometrial cohorts.