Study of Sacituzumab Govitecan in Patients With Solid Tumor

NCT05119907 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: EVER-132-003CTR20210912
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 13

Brief Summary

The goal of this study is to see how effective the study drug, sacituzumab govitecan-hziy, is in participants with solid tumor.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1) By Investigator Assessment

  ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR).

  Up to 4 years

Secondary Outcomes (10)

• Duration of Response (DOR)

  Up to 4 years

• Disease Control Rate (DCR)

  Up to 4 years

• Progression-free Survival (PFS)

  Up to 4 years

• Overall Survival (OS)

  Up to 4 years

• Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

  First dose date up to 4 years plus 30 days

Study Arms (5)

Cohort A: Esophageal Squamous Cell Carcinoma (ESCC)

EXPERIMENTAL

Participants will receive Sacituzumab Govitecan-hziy (SG) 8 or 10 mg/kg on Days 1 and 8 of a 21-day cycle. Participants will continue treatment until disease progression or intolerable toxicity or consent withdrawal for any reason.

Drug: Sacituzumab Govitecan-hziy

Cohort B: Gastric or Gastroesophageal Junction Adenocarcinoma (G/GEJC)

EXPERIMENTAL

Participants will receive SG 8 or 10 mg/kg on Days 1 and 8 of a 21-day cycle. Participants will continue treatment until disease progression or intolerable toxicity or consent withdrawal for any reason.

Drug: Sacituzumab Govitecan-hziy

Cohort C: Cervical Cancer (CC)

EXPERIMENTAL

Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle. Participants will continue treatment until disease progression or intolerable toxicity or consent withdrawal for any reason.

Drug: Sacituzumab Govitecan-hziy

Cohort D: Biliary Tract Cancer (BTC)

EXPERIMENTAL

Participants will receive SG 8 or 10 mg/kg on Days 1 and 8 of a 21-day cycle. Participants will continue treatment until disease progression or intolerable toxicity or consent withdrawal for any reason.

Drug: Sacituzumab Govitecan-hziy

Cohort E: Lung Adenocarcinoma (LAC)

EXPERIMENTAL

Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle. Participants will continue treatment until disease progression or intolerable toxicity or consent withdrawal for any reason.

Drug: Sacituzumab Govitecan-hziy

Interventions

Sacituzumab Govitecan-hziy DRUG

Administered intravenously

Also known as: IMMU-132, Trodelvy™, GS-0132

Cohort A: Esophageal Squamous Cell Carcinoma (ESCC); Cohort B: Gastric or Gastroesophageal Junction Adenocarcinoma (G/GEJC); Cohort C: Cervical Cancer (CC); Cohort D: Biliary Tract Cancer (BTC); Cohort E: Lung Adenocarcinoma (LAC)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (13)

Beijing Obstetrics and Gynecology Hospital, Capital Medical University

Beijing, 100006, China

Location

Chinese Academy of Medical Sciences Cancer Hospital

Beijing, 100021, China

Location

Beijing Cancer Hospital

Beijing, 100142, China

Location

The First Hospital of Jilin University

Changchun, 130021, China

Location

Fujian Cancer Hospital

Fuzhou, 350014, China

Location

The Sixth Affiliated Hospital, Sun Yat-Sen University

Guangzhou, 510655, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, 310003, China

Location

Zhejiang Cancer Hospital

Hangzhou, 310022, China

Location

Harbin Medical University Cancer Hospital

Harbin, 150076, China

Location

Anhui Provincial Hospital

Hefei, 230001, China

Location

Jiangsu Province Hospital

Nanjing, 210029, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 43006, China

Location

Henan Cancer Hospital

Zhengzhou, 450000, China

Location

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Interventions

sacituzumab govitecan

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 15, 2021
• Study Start: October 12, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (13)