A Study of Sacituzumab Govitecan (IMMU-132) in Platinum-resistant Ovarian Cancer Patients

NCT06028932 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2000036114000
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a non-randomized Phase 2 study of sacituzumab govitecan (IMMU-132) in subjects with recurrent or persistent platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancers.

Conditions

Ovarian Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Objective response rate (complete response and partial response rates) by RECIST1.1 criteria in patients with platinum resistant recurrent ovarian carcinoma.

  4 Years

Secondary Outcomes (4)

• Duration of overall survival (OS)

  6 Years

• Duration of progression free survival (PFS)

  6 Years

• Durable disease control rate (DDCR)

  6 Years

• Assess the safety profile of sacituzumab govitecan in ovarian cancer patients (adverse events as assessed by CTCAE v5.0)

  6 Years

Study Arms (1)

Sacituzumab govitecan, 10 mg/kg

EXPERIMENTAL

Sacituzumab govitecan, 10 mg/kg for the first 2 weeks of 21-day cycle until progression or adverse effects prohibit further treatment

Drug: Sacituzumab govitecan

Interventions

Sacituzumab govitecan DRUG

Sacituzumab govitecan will be administered at 10 mg/kg weekly as an infusion for 2 consecutive weeks (2 weekly doses plus 1 week without treatment represents a single 3 week cycle). Treatment can be continued without a rest period in the absence of progression of disease or unacceptable toxicity.

Also known as: IMMU-132

Sacituzumab govitecan, 10 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have platinum-resistant (i.e., platinum-free interval \<6 months) recurrent or persistent histologically confirmed epithelial (non-mucinous) ovarian, fallopian tube, or primary peritoneal cancer. Patients may have serous, endometrioid, clear cell, (pure or mixed), or undifferentiated histology.
• Must have availability of archival tumor tissue FFPE block for TROP-2 testing and other biomarkers.
• All patients must have measurable disease. Measurable disease is defined as lesions which can be measured by physical examination or by means of medical imaging techniques. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be ≥ 20 mm when measured by conventional techniques, including palpation or plain x-ray, or ≥ 10 mm when measured by spiral CT and/or MRI. Ascites and pleural effusions are not to be considered measurable disease.
• Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST v1.1. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented, or a biopsy is obtained to confirm persistence following completion of radiation therapy.
• After undergoing surgery, patients may be optimally or sub optimally debulked.
• Patients with measurable recurrent disease of any previous substage (I-IV) are eligible to enrollment.
• Patients must have adequate bone marrow function: WBC greater than or equal to 3,000/ul, Platelets greater than or equal to 75,000/ul, Neutrophils greater than or equal to 1500/ul.
• Patients must have adequate renal function: creatinine less than or equal to 2.0 mg/dL.
• Patients must have adequate hepatic function: bilirubin ≤ 1.5 institutional upper limit of normal, aspartate aminotransferase \[AST\], and alanine aminotransferase \[ALT\] ≤ 2.5 × IULN or ≤ 5 × IULN if known liver metastases
• Patients must have an ECOG performance status of 0 or 1.
• Patients must have signed an approved informed consent.
• Patients must be at least 2 weeks beyond prior treatment (chemotherapy, investigational drugs including small molecular inhibitors, endocrine therapy, immunotherapy and/or radiation therapy) or major surgery.
• Patients must be at least 2 weeks beyond high dose systemic corticosteroids (however, low dose corticosteroids \<20 mg prednisone or equivalent daily are permitted)
• Patients must have recovered from all acute toxicities to Grade 1 or less from adverse events due to a previously administered agent
• Note: Patients with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study

You may not qualify if:

• Patients with a positive serum pregnancy test or women who are breastfeeding.
• Patients with known hypersensitivity to the study drug, its metabolites, or formulation excipient.
• Patients who require ongoing therapy with or prior use of any prohibited medication(s) such as UGT1A1 inhibitors.
• Have 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.
• Any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the patient's participation in the study.
• Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancers or carcinoma in situ of the cervix, are excluded if there is any evidence of other malignancy being present within the last 5 years.
• Patients with a significant history of cardiac disease within 6 months, i.e., uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure (NYHA classification III-IV) or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring antiarrhythmia therapy.
• Patients with known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months
• Patients with any unstable medical issue (including cardiac issues as above, active treatment for symptomatic pulmonary embolism, CVA, renal or hepatic insufficiency, and active infection/sepsis requiring IV antibiotics).
• Have known active CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking ≤20 mg/day of prednisone or its equivalent. All patients with carcinomatous meningitis are excluded regardless of clinical stability
• Patients who have an uncontrolled seizure disorder, or active neurological disease.
• Have known history of HIV-1 or 2 (or positive HIV-1/2 antibody) with detectable viral load OR taking medications that may interfere with SN-38 metabolism
• Have active HBV or HCV. In subjects with a history of HBV or HCV, subjects with a detectable viral load will be excluded.
• Known hemorrhagic diathesis or active bleeding disorder.
• Patients with Gilbert's disease

Sponsors & Collaborators

• Yale University: lead
• Gilead Sciences: collaborator

Study Sites (1)

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

• Greenman M, Bellone S, Demirkiran C, Max Philipp Hartwich T, Santin AD. Sacituzumab govitecan in heavily pretreated, platinum-resistant high grade serous ovarian cancer. Gynecol Oncol Rep. 2024 Jul 13;54:101459. doi: 10.1016/j.gore.2024.101459. eCollection 2024 Aug.

  PMID: 39108617 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

sacituzumab govitecan

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

Study Officials

• Alessandro Santin, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 8, 2023
• Study Start: January 8, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)