~6 spots leftby Nov 2025

Sacituzumab Govitecan for Bile Duct Cancer

AK
Overseen byAnup K Kasi Loknath Kumar
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Kansas Medical Center
Must not be taking: Corticosteroids, UGT1A1 inhibitors
Disqualifiers: Pregnancy, CNS metastases, Cardiac disease, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial tests how well sacituzumab govitecan works in treating patients with cholangiocarcinoma that has spread to nearby tissue or lymph nodes (locally advanced), that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Sacituzumab govitecan is a monoclonal antibody, called hRS7, linked to a toxic agent, called SN-38. HRS7 is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as TROP2 receptors, and delivers SN-38 to kill them.

Will I have to stop taking my current medications?

The trial requires that you do not use other anti-cancer or investigational drugs while participating. If you are on high-dose corticosteroids or UGT1A1 inhibitors/inducers, you must stop them at least 2 weeks before starting the trial. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is Sacituzumab Govitecan safe for humans?

Sacituzumab Govitecan has been tested in humans with various advanced cancers, and common side effects include nausea, low white blood cell count (neutropenia), diarrhea, tiredness, low red blood cell count (anemia), vomiting, hair loss, constipation, rash, decreased appetite, and abdominal pain. These side effects were observed in more than 25% of patients in clinical trials.12345

How is the drug Sacituzumab Govitecan unique for treating bile duct cancer?

Sacituzumab Govitecan is unique because it is an antibody-drug conjugate (ADC) that specifically targets Trop-2, a protein found on many cancer cells, to deliver SN-38, a powerful chemotherapy agent, directly to the tumor. This targeted approach may offer a new option for bile duct cancer, which lacks many standard treatments.24678

Research Team

AK

Anup K Kasi Loknath Kumar

Principal Investigator

University of Kansas

Eligibility Criteria

This trial is for patients with advanced forms of bile duct cancer, including those whose cancer has spread locally, returned after treatment, or metastasized. Participants must have measurable disease and be able to undergo procedures like biopsies and scans.

Inclusion Criteria

Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
I agree to use contraception or practice abstinence during and after the study for the specified times.
See 11 more

Exclusion Criteria

I have not had any other cancer besides a low-risk, treated one in the last 3 years.
I have a genetic variation linked to higher risk of side effects from irinotecan.
I am currently using or have used drugs that affect UGT1A1.
See 20 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sacituzumab govitecan intravenously over 1-3 hours on days 1 and 8 of each 21-day cycle

Up to 2 years
2 visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

24 months
Every 3 months

Treatment Details

Interventions

  • Sacituzumab Govitecan (Monoclonal Antibodies)
Trial OverviewThe trial is testing Sacituzumab Govitecan's effectiveness on cholangiocarcinoma. It involves a monoclonal antibody targeting TROP2 receptors on tumor cells to deliver the toxic agent SN-38 directly to them.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (Sacituzumab govitecan)Experimental Treatment6 Interventions
Patients receive sacituzumab govitecan IV over 1-3 hours on days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, PET/CT or MRI scans, and blood sample collection throughout the study.

Sacituzumab Govitecan is already approved in Canada for the following indications:

🇨🇦
Approved in Canada as Trodelvy for:
  • Metastatic triple-negative breast cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials
527
Recruited
181,000+
Dr. Steve Stites profile image

Dr. Steve Stites

University of Kansas Medical Center

Chief Executive Officer

MD from University of Kansas School of Medicine

Dr. Matthias Salathe profile image

Dr. Matthias Salathe

University of Kansas Medical Center

Chief Medical Officer

MD from University of Kansas School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
Dr. Douglas R. Lowy profile image

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli profile image

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

Sacituzumab govitecan-hziy (TRODELVY) received accelerated FDA approval for treating metastatic triple-negative breast cancer (mTNBC) based on a trial involving 108 patients, showing an objective response rate of 33.3% and a median duration of response of 7.7 months.
The safety profile was assessed in a larger group of 408 patients, with common side effects including nausea, neutropenia, and fatigue, occurring in 25% or more of patients, indicating that while effective, the treatment can have significant adverse reactions.
FDA Approval Summary: Accelerated Approval of Sacituzumab Govitecan-hziy for Third-line Treatment of Metastatic Triple-negative Breast Cancer.Wahby, S., Fashoyin-Aje, L., Osgood, CL., et al.[2022]
Sacituzumab govitecan is an antibody-drug conjugate that targets Trop-2 and has shown a 33.3% overall response rate in patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies, based on a phase I/II study with 108 participants.
The treatment has a median duration of response of 7.7 months, and while it is generally well-tolerated, common side effects include nausea, neutropenia, and fatigue, indicating a need for monitoring during treatment.
Sacituzumab Govitecan-hziy: An Antibody-Drug Conjugate for the Treatment of Refractory, Metastatic, Triple-Negative Breast Cancer.Seligson, JM., Patron, AM., Berger, MJ., et al.[2021]
Sacituzumab govitecan received full FDA approval after a phase III trial showed it significantly improves progression-free survival in patients with metastatic triple-negative breast cancer, achieving a median of 5.7 months compared to just 1.7 months with standard chemotherapy.
This treatment is an antibody-drug conjugate that targets the Trop-2 receptor and delivers the active metabolite of irinotecan, SN-38, directly to cancer cells, making it a promising option for patients who have already undergone at least two prior therapies.
Sacituzumab Govitecan for Treatment of Refractory Triple-Negative Metastatic Breast Cancer.Fleming, PJ., Karpio, S., Lombardo, N.[2021]

References

FDA Approval Summary: Accelerated Approval of Sacituzumab Govitecan-hziy for Third-line Treatment of Metastatic Triple-negative Breast Cancer. [2022]
Sacituzumab Govitecan-hziy: An Antibody-Drug Conjugate for the Treatment of Refractory, Metastatic, Triple-Negative Breast Cancer. [2021]
Sacituzumab Govitecan for Treatment of Refractory Triple-Negative Metastatic Breast Cancer. [2021]
First-in-Human Trial of a Novel Anti-Trop-2 Antibody-SN-38 Conjugate, Sacituzumab Govitecan, for the Treatment of Diverse Metastatic Solid Tumors. [2022]
Sacituzumab govitecan (IMMU-132), an anti-Trop-2-SN-38 antibody-drug conjugate for the treatment of diverse epithelial cancers: Safety and pharmacokinetics. [2018]
An integrated analysis of Sacituzumab govitecan in relapsed or refractory metastatic triple-negative breast cancer. [2023]
Sacituzumab Govitecan: First Approval. [2021]
Sacituzumab Govitecan in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer. [2023]