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

NCT06040970 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: STUDY-23-00832
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Ovarian Cancer; Malignant Neoplasm of Uterus

Outcome Measures

Primary Outcomes (3)

• Dose-limiting toxicity (DLT) at the maximum tolerated dose (MTD) for the Safety Run-In Phase

  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.

  within the first cycle of therapy (each cycle = 21 days)

• Dose limiting toxicity (DLT) for the DEC Phase

  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.

  within 1 cycle of therapy (each cycle = 21 days)

• Overall Response Rate (ORR)

  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.

  every 3 cycles (each cycle is 21 days)

Secondary Outcomes (3)

• Clinical Benefit Response (CBR)

  6 months

• Progression free survival (PFS)

  6 months

• Number of adverse events

  6 months

Study Arms (2)

Ovarian cancer Cohort

EXPERIMENTAL

DEC 3+3 dose expansion of Sacituzumab Govitecan in Combination with Cisplatin

Drug: Sacituzumab; Drug: Cisplatin

Endometrial cancer Cohort

EXPERIMENTAL

DEC 3+3 dose expansion of Sacituzumab Govitecan in Combination with Cisplatin

Drug: Sacituzumab; Drug: Cisplatin

Interventions

Sacituzumab DRUG

Dose 0: Sacituzumab govitecan 7.5 mg/kg Dose -1: Sacituzumab govitecan 5 mg/kg

Also known as: Sacituzumab Govitecan

Endometrial cancer Cohort; Ovarian cancer Cohort

Cisplatin DRUG

Cisplatin 70 mg/m2 IV

Endometrial cancer Cohort; Ovarian cancer Cohort

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

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

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Uterine Neoplasms

Interventions

sacituzumab govitecan; Cisplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Amy Tiersten, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Tiersten, MD

CONTACT

(212) 241-3300; amy.tiersten@mssm.edu

Melanie Kier, MD

CONTACT

melanie.kier@mssm.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. Professor of Medicine (Hematology and Medical Oncology) Clinical Director, Breast Medical Oncology, Dubin Breast Center

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 18, 2023
• Study Start: October 23, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)