Ovarian CancerPhase 1/2NCT06040970
Sacituzumab Govitecan in Combination With Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer
A Phase 1/2 study testing Sacituzumab and Cisplatin in people with Ovarian Cancer and Malignant Neoplasm of Uterus, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Malignant Neoplasm of Uterus
- What is being tested?
- Sacituzumab and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2024to 1 Jul 2032
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
- o A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- 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.
Who cannot join
- Treatment with any of the following:
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Melanie Kier, MD contact
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai Division of Hematology and Medical Oncology
New York, New York, 10029
Amy Tiersten, MD, (212) 241-3300, amy.tiersten@mssm.edu
Melanie Kier, MD, melanie.kier@mssm.edu
About this study
Official title: A Single-Center, Open-Label, Single-Arm, Phase I Study With Dose Expansion Cohort of Sacituzumab Govitecan in Combination With Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer
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.
Read the detailed description
This is an open-label, Phase 1 study with a dose expansion cohort (DEC), conducted in two separate disease groups (ovarian and endometrial cancer). The primary objective 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.
For each disease group, there will be a safety run-in phase utilizing a 3+3 design with a de-escalated dose level if the starting dose shows toxicity and an expansion cohort to evaluate the preliminary efficacy and tolerability of the experimental regimen. The dose expansion cohort will consist of 14 patients in the ovarian cohort and 12 patients in the endometrial cohort with an additional 2 patients in each cohort to account for potential patient replacement. This will yield a total sample size of 22-28 patients in the ovarian cancer cohort and a total sample size of 20-26 patients in the endometrial cancer cohort.
Phase 1, Safety Run-in with Dose De-escalation Scheme:
Dose Level 0, starting level: Sacituzumab govitecan 7.5 mg/kg + Cisplatin 70 mg/m2 IV Dose -1: Sacituzumab govitecan 7.5 mg/kg + Cisplatin 70 mg/m2 IV In this stage, a minimum of 6 patients and a maximum of 12 patients will be required.
The recommended dose expansion cohort (DEC) dose is defined as the highest dose at which no more than 1 out of 6 patients experience a Dose-Limiting Toxicity (DLT)
Phase 2, Dose Expansion Cohort:
Sacituzumab govitecan 5-7.5 mg/kg IV (depending on phase I result) + Cisplatin 70 mg/m2 IV.
Drug product administration will continue until progressive disease (PD), unacceptable toxicity, or death.
The primary endpoint of the safety run-in phase is to determine the recommended DEC dose of Sacituzumab in combination with a fixed schedule of cisplatin in patients with ovarian and endometrial cancers. In the safety run-in phase, the assessment of dose limiting toxicity (DLT) will be performed standard 3 + 3 design rules. The recommended DEC dose is defined as the highest dose of Sacituzumab in combination with Cisplatin at the fixed dose of 70 mg/m2 at which no more than 1 out of 6 patients experience DLT within the first cycle of therapy.
The DEC is designed to indicate proof of concept regarding the overall response rate (ORR) and safety of the combination of sacituzumab with cisplatin at the dose established in the safety run-in phase of the study. Once the recommended DEC dose for sacituzumab and cisplatin combination has been established for each disease cohort, an additional 14 patients will be enrolled for the ovarian group and 12 patients for the endometrial group. An additional 2 patients will be added to each cohort to account for potential patient replacement for a total of 42-54 evaluable patients.
- Conditions
- Ovarian Cancer, Malignant Neoplasm of Uterus
- Being tested
- Sacituzumab, Cisplatin
- Medical subject headings
- Ovarian Neoplasms, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SacituzumabDrug
Also called Sacituzumab Govitecan
Dose 0: Sacituzumab govitecan 7.5 mg/kg
Dose -1: Sacituzumab govitecan 5 mg/kg
CisplatinDrug
Cisplatin 70 mg/m2 IV
| Study group | Role | What they receive |
|---|---|---|
| Ovarian cancer Cohort | Experimental | DEC 3+3 dose expansion of Sacituzumab Govitecan in Combination with Cisplatin Receives: Drug: Sacituzumab; Drug: Cisplatin |
| Endometrial cancer Cohort | Experimental | DEC 3+3 dose expansion of Sacituzumab Govitecan in Combination with Cisplatin Receives: Drug: Sacituzumab; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: every 3 cycles (each cycle is 21 days)
Secondary outcomes (3)
Clinical Benefit Response (CBR)
For the entire cohort (Safety Run-In and Dose Expansion Cohort), CBR will be measured by the percentage of patients whose cancer shrinks or remains stable over the duration of the study. This will be measured as the sum of complete response (CR), partial response (PR), and stable disease (SD) for greater than or equal to 6 months. Disease status will be assessed based on RECIST 1.1 criteria for measurable and non-measurable disease.
The analysis plan for all secondary endpoints will be conducted separately for each disease cohort (ovarian and endometrial).
Measured: 6 months
Progression free survival (PFS)
For the entire cohort (Safety Run-In and Dose Expansion Cohort), 6-month progression free survival (PFS) is as defined as the time from the start of treatment until confirmed disease progression or death from any cause, whichever occurs first. Disease status will be assessed with comprehensive radiographic studies every 3 treatment cycles (12 weeks +/- 1 week), but the development of new signs or symptoms of disease in between scheduled evaluations may prompt off-schedule radiographic or non-radiographic evaluations. Disease status will be assessed based on RECIST 1.1 criteria for measurable and non-measurable disease.
The analysis plan for all secondary endpoints will be conducted separately for each disease cohort (ovarian and endometrial).
Measured: 6 months
Number of adverse events
For the entire cohort (Safety Run-In and Dose Expansion Cohort), the type, incidence, severity (as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v5.0), seriousness and relationship to study medications of Adverse Events will be determined.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start28 Oct 2024
- Primary completion1 Jul 2031 (estimated)
- Study completion1 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Tiersten, Icahn School of Medicine at Mount Sinai
- Investigators
- Amy Tiersten, MD, Principal investigator, Icahn School of Medicine at Mount Sinai Division of Hematology and Medical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040970
- Sponsor's protocol ID
- STUDY-23-00832
- Status last verified
- Aug 2026
- First submitted
- 5 Sep 2023
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual participant data, supporting information, or biological samples that are collected as part of this study for future research, even if the participant's identity is removed. Data and samples will only be used to complete this study. If the results of this study are presented or reported in a publication, the participants will not be identified. All results will be kept confidential and will not be divulged without permission, except as required by law.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label, Single-Arm, Phase I Study With Dose Expansion Cohort of Sacituzumab Govitecan in Combination With Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer
- ClinicalTrials.gov ID
- NCT06040970
- Acronym / sponsor ID
- STUDY-23-00832
- Conditions
- Ovarian Cancer, Malignant Neoplasm of Uterus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 1 Jul 2031 (estimated)
- Study completion
- 1 Jul 2032 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label, Phase 1 study with a dose expansion cohort (DEC), conducted in two separate disease groups (ovarian and endometrial cancer). The primary objective 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.
For each disease group, there will be a safety run-in phase utilizing a 3+3 design with a de-escalated dose level if the starting dose shows toxicity and an expansion cohort to evaluate the preliminary efficacy and tolerability of the experimental regimen. The dose expansion cohort will consist of 14 patients in the ovarian cohort and 12 patients in the endometrial cohort with an additional 2 patients in each cohort to account for potential patient replacement. This will yield a total sample size of 22-28 patients in the ovarian cancer cohort and a total sample size of 20-26 patients in the endometrial cancer cohort.
Phase 1, Safety Run-in with Dose De-escalation Scheme:
Dose Level 0, starting level: Sacituzumab govitecan 7.5 mg/kg + Cisplatin 70 mg/m2 IV Dose -1: Sacituzumab govitecan 7.5 mg/kg + Cisplatin 70 mg/m2 IV In this stage, a minimum of 6 patients and a maximum of 12 patients will be required.
The recommended dose expansion cohort (DEC) dose is defined as the highest dose at which no more than 1 out of 6 patients experience a Dose-Limiting Toxicity (DLT)
Phase 2, Dose Expansion Cohort:
Sacituzumab govitecan 5-7.5 mg/kg IV (depending on phase I result) + Cisplatin 70 mg/m2 IV.
Drug product administration will continue until progressive disease (PD), unacceptable toxicity, or death.
The primary endpoint of the safety run-in phase is to determine the recommended DEC dose of Sacituzumab in combination with a fixed schedule of cisplatin in patients with ovarian and endometrial cancers. In the safety run-in phase, the assessment of dose limiting toxicity (DLT) will be performed standard 3 + 3 design rules. The recommended DEC dose is defined as the highest dose of Sacituzumab in combination with Cisplatin at the fixed dose of 70 mg/m2 at which no more than 1 out of 6 patients experience DLT within the first cycle of therapy.
The DEC is designed to indicate proof of concept regarding the overall response rate (ORR) and safety of the combination of sacituzumab with cisplatin at the dose established in the safety run-in phase of the study. Once the recommended DEC dose for sacituzumab and cisplatin combination has been established for each disease cohort, an additional 14 patients will be enrolled for the ovarian group and 12 patients for the endometrial group. An additional 2 patients will be added to each cohort to account for potential patient replacement for a total of 42-54 evaluable patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ovarian cancer Cohort | Experimental | Drug: Sacituzumab, Drug: CisplatinDEC 3+3 dose expansion of Sacituzumab Govitecan in Combination with Cisplatin |
| Endometrial cancer Cohort | Experimental | Drug: Sacituzumab, Drug: CisplatinDEC 3+3 dose expansion of Sacituzumab Govitecan in Combination with Cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SacituzumabAlso: Sacituzumab GovitecanDose 0: Sacituzumab govitecan 7.5 mg/kg Dose -1: Sacituzumab govitecan 5 mg/kg | Drug | Endometrial cancer Cohort, Ovarian cancer Cohort |
| CisplatinCisplatin 70 mg/m2 IV | Drug | Endometrial cancer Cohort, Ovarian cancer Cohort |
Primary outcome
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)
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 Phase
Time frame: within 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)
Time frame: 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.
3 secondary outcomes
Clinical Benefit Response (CBR)
Time frame: 6 months
Progression free survival (PFS)
Time frame: 6 months
Number of adverse events
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data, supporting information, or biological samples that are collected as part of this study for future research, even if the participant's identity is removed. Data and samples will only be used to complete this study. If the results of this study are presented or reported in a publication, the participants will not be identified. All results will be kept confidential and will not be divulged without permission, except as required by law.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melanie Kier, MD contact
Amy Tiersten, MD principal investigator
Icahn School of Medicine at Mount Sinai Division of Hematology and Medical Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sacituzumab and Cisplatin in people with Ovarian Cancer and Malignant Neoplasm of Uterus, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Tiersten, MD ((212) 241-3300, amy.tiersten@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.