Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
FEMALE
NCT06040970

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

Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-12-02

54

Participants Needed

1

Research Sites

140 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is an open-label, Phase 1 study with a dose expansion cohort of Sacituzumab Govitecan in Combination with Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer. The goal of the study is to determine the optimal dose of sacituzumab govitecan for use in combination with cisplatin for treatment of epithelial ovarian and endometrial cancers.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologic confirmed diagnosis of epithelial ovarian cancer or endometrial cancer
  • Radiographic evidence of recurrent platinum-sensitive epithelial ovarian or endometrial cancer with progression beyond 6 months from last platinum-based chemotherapy
  • Female, age 18 years or older
  • WHO performance status 0-1 with no deterioration over previous 2 weeks and minimum life expectancy of 12 weeks
  • Measurable or evaluable disease on baseline CT or PET/CT scans
  • Adequate blood counts without recent transfusion or growth factor support: hemoglobin 7 8.5 g/dL, neutrophils 7 1500/mm3, platelets 7 100,000/bcL
  • Adequate organ function: total bilirubin 4 1.5 times upper limit, AST/ALT 4 2.5x upper limit (or 4 5x if liver metastases), serum albumin > 3 g/dL, creatinine clearance 7 50 mL/min
  • Women of childbearing potential agree to use contraception during study and for 6 months after
  • Ability and willingness to sign informed consent
Not Eligible

You will not qualify if you...

  • Use of investigational agents within 28 days or 5 half-lives before study treatment
  • Other chemotherapy, immunotherapy, or anticancer agents within 14 days before study treatment
  • Major surgery within 4 weeks before study treatment (except vascular access placement)
  • Recent radiotherapy within 4 weeks (wide field) or 2 weeks (limited field for palliation)
  • Unresolved toxicities greater than CTCAE grade 1 except alopecia at treatment start
  • Severe or uncontrolled systemic diseases or infections including hepatitis B, C, or HIV
  • Known severe hypersensitivity to sacituzumab govitecan, cisplatin, or their components
  • Peripheral neuropathy grade 2 or higher
  • Refractory nausea, vomiting, or chronic gastrointestinal diseases
  • Pregnant or nursing women
  • Women unwilling to use effective contraception during and 6 months post-study
  • Recent unstable angina, myocardial infarction, congestive heart failure, or serious arrhythmias
  • Active moderate-to-severe chronic respiratory illness within 6 months
  • Recent significant bleeding, intestinal obstruction, or GI perforation within 6 months
  • Other medical or psychiatric conditions that could interfere with study participation
  • Prior therapy with sacituzumab govitecan, irinotecan, Trop-2 antibody-drug conjugates, or topoisomerase I antibody-drug conjugates
  • Active chronic inflammatory bowel disease or recent GI perforation
  • Requirement for ongoing prohibited medications
  • Active CNS metastases or carcinomatous meningitis (with some exceptions for stable treated brain metastases)
  • Active second malignancy except certain low-risk or treated cancers
  • Live vaccine within 30 days before first dose
  • Active serious infection requiring systemic antibiotics

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Icahn School of Medicine at Mount Sinai Division of Hematology and Medical Oncology

New York, New York, United States, 10029

Actively Recruiting

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Research Team

A

Amy Tiersten, MD

CONTACT

M

Melanie Kier, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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