Treatment with Sacituzumab Govitecan for Patients with Solid Tumors

A Phase II Open Label Study of Sacituzumab Govitecan in Patients With Solid Tumor

This study is testing a new drug called sacituzumab govitecan to see if it can help people with advanced cervical cancer who haven't had success with other treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Gilead Sciences (Industry-sponsored)
• Drugs / interventions: chemotherapy, prednisone, sacituzumab
• Locations: 16 sites (Beijing and 15 other locations)
• Trial ID: NCT05119907 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of sacituzumab govitecan-hziy in patients with solid tumors, specifically focusing on those with cervical cancer who have not responded to previous chemotherapy treatments. The trial is currently enrolling participants in Cohort C, which targets individuals with incurable locally advanced or metastatic cervical cancer. Participants must have a performance status of 0 or 1 and meet specific criteria regarding their cancer treatment history. The study aims to gather data on the drug's safety and efficacy in this patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with locally advanced or metastatic cervical cancer who have not responded to prior platinum-based and taxane-based chemotherapy.

Not a fit: Patients with solid tumors other than cervical cancer or those who have not undergone prior chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cervical cancer who have limited treatment alternatives.

How similar studies have performed: Other studies involving sacituzumab govitecan have shown promise in treating various solid tumors, indicating potential for success in this approach.

Eligibility criteria

Key Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
* Histologically or cytologically-documented, incurable locally advanced or metastatic solid tumor of one of the following types:

  * Cohort A: oesophageal squamous-cell carcinoma that was refractory or intolerant to fluoropyrimidine-based, platinum-based, and taxane-based chemotherapy.
  * Cohort B: gastric adenocarcinoma that was refractory or intolerant to fluoropyrimidine-based, platinum-based, and taxane-based chemotherapy.
  * Cohort C: cervical cancer that was refractory or intolerant to platinum-based and taxane-based chemotherapy.
  * Cohort D: biliary tract cancer, including intrahepatic cholangiocarcinoma (IHCC), extrahepatic cholangiocarcinoma (EHCC), and gallbladder cancer (GBC), with exception of ampullary carcinoma, progressed during or after first line platinum-based or fluoropyrimidine-based chemotherapy.
  * Cohort E: lung adenocarcinoma with activating genomic alterations (EGFR/ ALK/ ROS1/ BRAF/ MET/ RET) that was refractory or intolerant to targeted tyrosine kinase inhibitors (TKIs) and had not received platinum-based chemotherapy for unresectable local advanced or metastatic disease, and no suitable or willing to receive platinum-based chemotherapy.
* Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) in accordance with RECIST v 1.1, bone-only disease is not measurable and is not permitted.
* Availability of archival tumor tissue or newly acquired biopsy (unstaining tumor slides, recommended from metastasis sites).
* Adequate bone marrow, hepatic and renal function.
* Recovered from all prior treatment-related toxicities to Grade 1 or less by NCI-CTCAE v 5.0 (except alopecia or peripheral neuropathy that may be Grade 2 or less).
* Individuals must have completed all prior cancer treatments at least 2 weeks prior to the first dose including chemotherapy , radiotherapy and major surgery. Prior antibody treatment for cancer must have been completed at least 3 weeks prior to the first dose.
* Individuals must have at least a 3-month life expectancy.

Key Exclusion Criteria:

* Previous treatment with topoisomerase I inhibitors as a free form or as other formulations.
* Previous treatment with Trop-2 targeted therapy.
* Individuals with a history of or current central nervous system (CNS) metastases.
* Known additional malignancy within 3 years prior to enrollment with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cancers.
* Individuals known to be human immunodeficiency virus positive.
* Individuals with active hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Hepatitis B core antibody (HBcAb) testing is required and if positive, then HBV DNA testing will be performed and if positive the individual will be excluded.
* Known history of unstable angina, myocardial infarction (MI), or chronic heart failure present within 6 months of first dose or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy or left ventricular ejection fraction \< 50%.
* Known history of clinically significant active chronic obstructive pulmonary disease, or other moderate-to-severe chronic respiratory illness present within 6 months of the first dose.
* Infection requiring systematic antibiotic use within 1 week of the first dose.
* Individuals with active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease) and individuals with a history of bowel obstruction or gastrointestinal (GI) perforation.
* High dose systemic corticosteroids within 2 weeks prior to the first dose (however, low dose corticosteroids ≤ 10 mg prednisone or equivalent daily are permitted provided the dose is stable for 4 weeks).
* Individuals who have received a live vaccine within 30 days of first dose.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where this trial is running

Beijing and 15 other locations

• Beijing Obstetrics and Gynecology Hospital, Capital Medical University — Beijing, China (Recruiting)
• Chinese Academy of Medical Sciences Cancer Hospital — Beijing, China (Recruiting)
• Beijing Cancer Hospital — Beijing, China (Recruiting)
• The First Hospital of Jilin University — Changchun, China (Recruiting)
• Fujian Cancer Hospital — Fuzhou, China (Completed)
• Fujian Cancer Hospital — Fuzhou, China (Recruiting)
• The Sixth Affiliated Hospital, Sun Yat-Sen University — Guangzhou, China (Completed)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, China (Completed)
• Harbin Medical University Cancer Hospital — Harbin, China (Recruiting)
• Anhui Provincial Hospital — Hefei, China (Recruiting)
• Jiangsu Province Hospital — Nanjing, China (Completed)
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, China (Recruiting)
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, China (Completed)
• Henan Cancer Hospital — Zhengzhou, China (Recruiting)

Study contacts

• Study coordinator: Gilead Clinical Study Information Center

Conditions Solid Tumor