SN-38

Generic Name: SN-38

Brand Names: Trodelvy

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₂₀N_₂O_₅

CAS Number: 86639-52-3

Unique Ingredient Identifier: 0H43101T0J

Background: 7-ethyl-10-hydroxycamptothecin (SN 38) is a liposomal formulation of the active metabolite of Irinotecan Irinotecan, a chemotherapeutic pro-drug approved for the treatment of advanced colorectal cancer. SN 38 has been used in trials studying the treatment of Cancer, Advanced Solid Tumors, Small Cell Lung Cancer, Metastatic Colorectal Cancer, and Triple Negative Breast Cancer, among others.

Indication: Investigated for use/treatment in colorectal cancer.

Associated Conditions: Hormone Receptor Positive Metastatic Breast Cancer, Locally Advanced or Metastatic Urothelial Carcinoma (UC), Metastatic Triple Negative Breast Cancers, Unresectable Triple-Negative Breast Carcinoma, Metastatic HR Positive, HER2/Neu Negative Breast Cancer, Unresectable Locally Advanced Triple-negative Breast Cancer, Unresectable, locally advanced HR Positive, HER2/Neu Negative Breast Cancer, Unresectable, locally advanced Hormone Receptor Positive Breast Carcinoma

Clinical Trials

Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy

Phase 3

Active, not recruiting

Conditions: Locally Advanced or Unresectable Metastatic Breast Cancer
Stage IV Breast Cancer

Interventions: Drug: Sacituzumab Govitecan-hziy
Drug: Paclitaxel
Drug: Nab-paclitaxel
Drug: Capecitabine

First Posted Date: 2023-05-03

Last Posted Date: 2024-08-29

Lead Sponsor: Gilead Sciences

Target Recruit Count: 654

Registration Number: NCT05840211

Locations: 🇰🇷
Samsung Medical Center, Gangnam-Gu, Korea, Republic of
🇲🇽
Centro de Atención e Investigación Clínica en Oncología, Yucatán, Mexico
🇵🇱
Wojewodzki Szpital Specjalistyczny lm. Stefana Kardynala Wyszynsklego SPZOZ w Lublinie, Lublin, Poland

and more 283 locations

A Study of Sacituzumab Govitecan (IMMU-132) in Patients With Recurrent or Persistent Cervical Cancer

Phase 2

Recruiting

Conditions: Cervical Cancer

Interventions: Drug: Sacituzumab govitecan

First Posted Date: 2023-05-01

Last Posted Date: 2024-12-17

Lead Sponsor: Yale University

Target Recruit Count: 20

Registration Number: NCT05838521

Locations: 🇺🇸
Smilow Cancer Hospital at Yale New Haven, New Haven, Connecticut, United States

Adaptive RADiation Therapy with Concurrent Sacituzumab Govitecan (SG) for Muscle Invasive Bladder Cancer

Phase 1

Recruiting

Conditions: Muscle-Invasive Bladder Carcinoma
Localized Muscle Invasive Bladder Urothelial Carcinoma

Interventions: Drug: Sacituzumab govitecan
Radiation: Adaptive Radiotherapy

First Posted Date: 2023-04-27

Last Posted Date: 2024-12-30

Lead Sponsor: Shilpa Gupta, MD

Target Recruit Count: 20

Registration Number: NCT05833867

Locations: 🇺🇸
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy

Phase 2

Recruiting

Conditions: Metastatic Triple-Negative Breast Carcinoma
Metastatic HER2-Negative Breast Carcinoma

Interventions: Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Biological: Sacituzumab Govitecan

First Posted Date: 2023-03-15

Last Posted Date: 2025-04-04

Lead Sponsor: Vanderbilt-Ingram Cancer Center

Target Recruit Count: 160

Registration Number: NCT05770531

Locations: 🇺🇸
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States

A Phase II Study of Neoadjuvant Sacituzumab Govitecan and Pembrolizumab Therapy for Immunochemotherapy-resistant Early-stage Triple-negative Breast Cancer (TNBC)

Phase 2

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Sacituzumab Govitecan
Drug: Pembrolizumab

First Posted Date: 2023-01-09

Last Posted Date: 2025-03-24

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 25

Registration Number: NCT05675579

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46)

Phase 3

Recruiting

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Biological: Sacituzumab Govitecan
Biological: Pembrolizumab

First Posted Date: 2022-11-08

Last Posted Date: 2024-11-18

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 614

Registration Number: NCT05609968

Locations: 🇺🇸
Houston Methodist Hospital ( Site 0419), Houston, Texas, United States
🇷🇴
Cardiomed SRL Cluj-Napoca ( Site 0217), Cluj-Napoca, Cluj, Romania
🇺🇸
Infirmary Cancer Care ( Site 0418), Mobile, Alabama, United States

and more 163 locations

Sacituzumab Govitecan Before Radical Cystectomy for the Treatment of Non-Urothelial Muscle Invasive Bladder Cancer

Phase 2

Recruiting

Conditions: Muscle Invasive Bladder Carcinoma
Stage II Bladder Cancer AJCC v8
Stage IIIA Bladder Cancer AJCC v8

Interventions: Procedure: Lymphadenectomy
Procedure: Radical Cystectomy
Biological: Sacituzumab Govitecan

First Posted Date: 2022-10-14

Last Posted Date: 2025-04-16

Lead Sponsor: University of Washington

Target Recruit Count: 18

Registration Number: NCT05581589

Locations: 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer

Phase 3

Recruiting

Conditions: Triple Negative Breast Cancer
Metastatic Breast Cancer

Interventions: Drug: Sacituzumab govitecan

First Posted Date: 2022-09-23

Last Posted Date: 2025-01-14

Lead Sponsor: UNICANCER

Target Recruit Count: 96

Registration Number: NCT05552001

Locations: 🇫🇷
Gustave Roussy, Villejuif, France

Preventive stRategy for IMMU132-relatED AEs in TNBC - PRIMED

Phase 2

Active, not recruiting

Conditions: Breast Cancer
Triple Negative Breast Cancer

Interventions: Drug: Sacituzumab govitecan
Drug: Loperamide
Drug: Granulocyte Colony-Stimulating Factor

First Posted Date: 2022-08-30

Last Posted Date: 2025-05-04

Lead Sponsor: MedSIR

Target Recruit Count: 50

Registration Number: NCT05520723

Locations: 🇪🇸
Hospital Universitario Donostia, San Sebastián, Donostia, Spain
🇪🇸
Hospital Universitario General de Catalunya, Sant Cugat Del Vallès, Barcelona, Spain
🇪🇸
Hospital Arnau de Vilanova, Lleida, Spain

and more 7 locations

Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

Phase 3

Active, not recruiting

Conditions: Triple Negative Breast Cancer
PD-L1 Positive

Interventions: Drug: Sacituzumab Govitecan-hziy
Drug: Pembrolizumab
Drug: Paclitaxel
Drug: nab-Paclitaxel
Drug: Gemcitabine
Drug: Carboplatin

First Posted Date: 2022-05-19

Last Posted Date: 2024-12-24

Lead Sponsor: Gilead Sciences

Target Recruit Count: 440

Registration Number: NCT05382286

Locations: 🇺🇸
University of Pennsylvania Abramson Cancer Center, Philadelphia, Pennsylvania, United States
🇺🇸
Magee-Womens Hospital of UPMC, Pittsburgh, Pennsylvania, United States
🇺🇸
Magee-Womens Hospital of UPMC,5115 Centre Avenue, Pittsburgh, Pennsylvania, United States

and more 501 locations

Drug Development Updates

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