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

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06040970
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sacituzumab — DRUG
    Dose 0: Sacituzumab govitecan 7.5 mg/kg Dose -1: Sacituzumab govitecan 5 mg/kg
  • Cisplatin — DRUG
    Cisplatin 70 mg/m2 IV

Study Details

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.

Key Dates

Start date
Oct 23, 2024
Status verified
Nov 2025
Primary completion
Jul 1, 2026
Completion
Jul 1, 2027

Study Design

Enrollment
54 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ovarian cancer Cohort
    DEC 3+3 dose expansion of Sacituzumab Govitecan in Combination with Cisplatin
  • Experimental: Endometrial cancer Cohort
    DEC 3+3 dose expansion of Sacituzumab Govitecan in Combination with Cisplatin

Primary Outcome Measure

Dose-limiting toxicity (DLT) at the maximum tolerated dose (MTD) for the Safety Run-In Phase [ Time Frame: within the first cycle of therapy (each cycle = 21 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount Sinai Division of Hematology and Medical OncologyNew YorkNew York10029
Amy Tiersten, MD
[email protected]
(212) 241-3300
Melanie Kier, MD
[email protected]
Amy Tiersten (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Icahn School of Medicine at Mount Sinai Division of Hematology and Medical Oncology· New York, NY

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