Clinical Trials Using Sacituzumab Govitecan

Clinical trials are research studies that involve people. The clinical trials on this list are studying Sacituzumab Govitecan. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-14 of 14
  • Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer

    This is an international, multi-center, open-label, phase II study in patients with metastatic urothelial cancer after failure of platinum-based regimen or anti-PD-1 / PD-L1 based immunotherapy. At least 201 patients are anticipated to be enrolled across approximately 40 sites from North America and Europe.
    Location: 14 locations

  • Sacituzumab Govitecan before Surgery for the Treatment of Localized Triple-Negative Breast Cancer, The NeoSTAR Trial

    This phase II trial studies whether sacituzumab govitecan is effective and safe before surgery for the treatment of patients with triple-negative breast cancer that has not spread to other parts of the body (localized). Sacituzumab govitecan is an antibody-drug conjugate which means it’s made up of an antibody attached to an anticancer drug. An antibody is a protein normally made by the immune system (the system in the body that fights off diseases). Sacituzumab govitecan may work by binding the antibody portion of the drug to the tumor(s) while the anticancer drug portion works to prevent tumor cells from growing / spreading.
    Location: 5 locations

  • Sacituzumab Govitecan and Talazoparib for the Treatment of Stage IV Triple-Negative Breast Cancer

    This phase Ib / II trial studies the side effects and best dose of sacituzumab govitecan and talazoparib in treating patients with stage IV triple-negative breast cancer. Sacituzumab govitecan is an antibody-drug conjugate which means it’s made up of an antibody attached to an anticancer drug. An antibody is a protein normally made by the immune system (the system in the body that fights off diseases). Sacituzumab govitecan is believed to work by binding the antibody portion of the drug to the tumor(s) while the anticancer drug portion works to prevent the tumor cells from growing / spreading. Talazoparib belongs to a group of drugs called PARP inhibitors. PARP is a protein that is involved with repairing damaged deoxyribonucleic acid (DNA) (the genetic material of cells). Talazoparib is believed to work by inhibiting (stopping) the PARP proteins from working in tumor cells so that the cancer cannot fix its damaged DNA. Sacituzumab govitecan and talazoparib may help stop tumors from growing and spreading by administering an anticancer drug directly to the cancerous tumor(s) through sacituzumab govitecan and by stopping the cancer’s cells from fixing its damaged DNA through talazoparib.
    Location: 3 locations

  • A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Patients With a Solid Tumor (SEASTAR)

    This is an open label, Phase 1b / 2 study with multiple treatment arms evaluating the safety, tolerability, PK, and preliminary efficacy of rucaparib in combination with a second anticancer therapy in patients with an advanced / metastatic solid malignancy (Phase 1b), followed by evaluation of the combination in one or more specific patient populations in an expansion phase (Phase 2 cohorts).
    Location: 3 locations

  • A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic or Inoperable Locally Advanced Triple-Negative Breast Cancer

    This is a Phase Ib / II, open-label, multicenter, randomized umbrella study evaluating the efficacy and safety of multiple immunotherapy-based treatment combinations in patients with metastatic or inoperable locally advanced TNBC. The study will be performed in two stages. During Stage 1, two cohorts will be enrolled in parallel in this study: one cohort will consist of Programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line [1L] PD-L1+ cohort), and one cohort will consist of participants who had disease progression during or following 1L treatment with chemotherapy (e.g., paclitaxel, nab-paclitaxel, carboplatin) and have not received cancer immunotherapy (CIT) (second-line [2L] CIT-naive cohort). In addition, participants in the 2L CIT-naive cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination (Stage 2), provided Stage 2 is open for enrollment.
    Location: 3 locations

  • Testing the Addition of Pembrolizumab to Sacituzumab Govitecan for the Treatment of PD-L1 Negative Locally Advanced Unresectable or Metastatic Triple Negative Breast Cancer

    This phase II trial investigates how well the addition of pembrolizumab to sacituzumab govitecan works in treating patients with PD-L1 negative triple negative breast cancer that has spread from its original site of growth to nearby tissues or lymph nodes and is not amenable to surgical resection (locally advanced unresectable) or to other places in the body (metastatic). Sacituzumab govitecan is composed of a chemotherapy drug, called irinotecan, which is attached to an antibody. Antibodies are proteins normally made by the immune system that bind to substances that don't belong in the body to prevent harm. Sacituzumab govitecan binds to the cancer cells and kills them. Pembrolizumab is an immunotherapy, called an anti-PD-1 or a checkpoint inhibitor, and is an antibody (a type of human protein) designed to allow the body’s own immune system to seek out and destroy tumors. This trial is being done to evaluate the effectiveness of sacituzumab govitecan alone or in combination with pembrolizumab, in delaying the worsening of triple negative breast cancers that are PD-L1 negative.
    Location: 2 locations

  • Sacituzumab Govitecan Alone or in Combination with Pembrolizumab for the Treatment of Hormone Receptor+, HER2-, and PD-L1+ Metastatic Breast Cancer

    This phase II trial studies the effect of sacituzumab govitecan alone or in combination with pembrolizumab in treating patients with hormone receptor positive (HR+) / HER2 negative, PD-L1 positive breast cancer that has spread to other places in the body (metastatic). Sacituzumab govitecan is composed of a chemotherapy drug, called irinotecan, which is attached to an antibody, which are proteins normally made by the immune system that bind to substances that don’t belong in the body to prevent harm. The antibody in this study binds to certain types of cancer tumors, including HR+ / HER2- tumors. Pembrolizumab is an immunotherapy, called an anti-PD-1 or a checkpoint inhibitor, and is an antibody (a type of human protein) designed to allow the body’s own immune system to seek out and destroy tumors. Giving sacituzumab govitecan alone or in combination with pembrolizumab may work better in delaying the worsening of HR+ / HER2- breast cancers that are also positive for PD-L1.
    Location: 2 locations

  • A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-based Treatment Combinations in Patients With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy

    A Phase Ib / II, open-label, multicenter, randomized, umbrella study in participants with locally advanced or metastatic Urothelial Carcinoma (UC) who have progressed during or following a platinum-containing regimen. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the participant population (e.g., with regard to prior anti-cancer treatment or biomarker status).
    Location: 2 locations

  • Sacituzumab Govitecan in Treating Patients with Metastatic Castration-Resistant Prostate Cancer Who Have Progressed on Second Generation Androgen Receptor-Directed Therapy

    This phase II trial studies how well sacituzumab govitecan works in treating patients with castration-resistant prostate cancer that has spread to other places in the body and progressed on second generation androgen receptor-directed therapy. Immunotherapy with sacituzumab govitecan may induce changes in the body’s immune system and may interfere with the ability of tumor cells to grow and spread.
    Location: 3 locations

  • A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)

    This study will evaluate the efficacy, safety, and pharmacokinetics of immunotherapy-based treatment combinations in patients with metastatic non-small cell lung cancer (NSCLC). Two cohorts will be enrolled in parallel in this study: the first-line (1L) cohort will consist of patients who have not received any systemic therapy for their disease and the second-line (2L) cohort will consist of patients who progressed during or after receiving a platinum-containing regimen and a PD-L1 / PD-1 checkpoint inhibitor treatment. In each cohort, eligible patients will be assigned to one of several treatment arms.
    Location: 3 locations

  • Sacituzumab Govitecan for the Treatment of Persistent or Recurrent Endometrial Cancer

    This phase II trial studies how well sacituzumab govitecan works in treating patients with endometrial cancer that remains despite treatment (persistent) or has come back (recurrent). Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug called govitecan. Sacituzumab attaches to TROP2 positive cancer cells in a targeted way and delivers govitecan to kill them.
    Location: Yale University, New Haven, Connecticut

  • Sacituzumab Govitecan in Treating Patients with Breast Cancer Brain Metastasis or Recurrent Glioblastoma

    This early phase I trial studies the extent by which sacituzumab govitecan is able get into the brain in treating patients with breast cancer that has spread to the brain (brain metastasis) or glioblastoma that has come back after previous treatment (recurrent). Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug called govitecan. Sacituzumab attaches to TROP2 positive tumor cells in a targeted way and delivers govitecan to kill them.
    Location: Cancer Therapy and Research Center at The UT Health Science Center at San Antonio, San Antonio, Texas

  • Rollover Study in Subjects With Metastatic Solid Tumors Benefiting From Therapy With Sacituzumab Govitecan

    Rollover study designed to evaluate long-term safety in subjects with metastatic solid tumors that are benefiting from continued treatment with sacituzumab govitecan. Patients currently receiving, clinically benefiting from, and tolerating sacituzumab govitecan in an Immunomedics-sponsored parent study planned for closure will be considered for enrollment.
    Location: 2 locations

  • A Study of Sacituzumab Govitecan in Metastatic Solid Tumors (TROPICS-03)

    A Phase 2 Open Label Study of Sacituzumab Govitecan (IMMU0132) in Subjects With Metastatic Solid Tumors
    Location: 8 locations