Sacituzumab Govitecan for the Treatment for Patients With Locally Advanced, Recurrent, or Metastatic Cholangiocarcinoma

NCT06178588 | Active Not Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: STUDY00150700NCI-2023-09080IIT-2023-SIGNAP30CA168524
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Locally Advanced Cholangiocarcinoma; Metastatic Cholangiocarcinoma; Recurrent Cholangiocarcinoma; Stage III Hilar Cholangiocarcinoma AJCC v8; Stage III Intrahepatic Cholangiocarcinoma AJCC v8; Stage IV Hilar Cholangiocarcinoma AJCC v8; Stage IV Intrahepatic Cholangiocarcinoma AJCC v8

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  Defined as best response recorded from the start of the treatment until the end of treatment (taking into account any requirement for confirmation). Measured by computed tomography (CT) (magnetic resonance imaging \[MRI\] if CT contraindicated) Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Will be reported as a proportion with corresponding 90% confidence interval.

  From start of treatment, up to 2 years

Secondary Outcomes (5)

• Incidence of adverse events

  From enrollment to 30 days after last administration of study treatment

• Anti-tumor activity: Duration of response

  From enrollment to end of follow up, up to 2 years

• Anti-tumor activity: Disease control rate

  From enrollment to end of follow up, up to 2 years

• Progression free survival

  From start of treatment until objective tumor progression or death, up to 2 years

• Overall survival

  From start of treatment to death, up to 2 years

Study Arms (1)

Treatment (Sacituzumab govitecan)

EXPERIMENTAL

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.

Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Biological: Sacituzumab Govitecan

Interventions

Biopsy PROCEDURE

Undergo tumor biopsy

Also known as: BIOPSY_TYPE, Bx

Treatment (Sacituzumab govitecan)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (Sacituzumab govitecan)

Computed Tomography PROCEDURE

Undergo PET/CT scan

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography

Treatment (Sacituzumab govitecan)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Treatment (Sacituzumab govitecan)

Positron Emission Tomography PROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

Treatment (Sacituzumab govitecan)

Sacituzumab Govitecan BIOLOGICAL

Given IV

Also known as: hRS7-SN38 Antibody Drug Conjugate, IMMU-132, RS7-SN38, Sacituzumab Govitecan-hziy, Trodelvy

Treatment (Sacituzumab govitecan)

Eligibility Criteria

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

You may qualify if:

• Ability of participant or legally authorized representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
• Males and females age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
• Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days before day 1 of study treatment
• Locally advanced, recurrent or metastatic cholangiocarcinoma) after progressing or intolerant to at least one line of systemic therapy
• Adequate archival tissue from prior biopsy for biomarker evaluation or willingness to undergo tissue biopsy before treatment starts and on treatment. Patients who, in the opinion of the investigator, do not have tissue that can be safely biopsied are exempted
• Absolute neutrophil count ≥ 1.5 K/UL
• Hemoglobin ≥ 9 g/dL
• Platelets ≥ 100K/UL
• Creatinine clearance ≥ 30 mL/min as assessed by the Cockcroft-Gault equation {Cockcroft 1976} or Creatinine clearance ≥ 60 mL/min
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN) OR direct bilirubin ≤ 1 x ULN
• Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
• Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception for the duration of study participation and as follows:
• Females: for 6 months following completion of therapy

You may not qualify if:

• Simultaneously enrolled in any therapeutic clinical trial
• Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study
• Treatment with chemotherapy, biologics, or investigational agents that is not completed 4 weeks or 5 half-lives (whichever is longer) prior to first dose of study drug
• Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
• Other underlying medical condition that, in the opinion of the investigator, would impair the ability of the participant to receive or tolerate the planned treatment and follow-up; any known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study
• Is pregnant or breastfeeding
• Known homozygosity in the UGT1A1\*28 allele associated with irinotecan toxicity
• Known hypersensitivity (≥ grade 3) to the study drug, its metabolites, or formulation excipient
• Requirement for ongoing therapy with (or prior use within 2 weeks of cycle 1, day 1) high dose systemic corticosteroids (≥ 20 mg of prednisone or its equivalent)
• Requirement for ongoing therapy with or prior use of UGT1A1 inhibitors/inducers
• Active grade 3 (per the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment
• Have not recovered (i.e., ≥ grade 2 is considered not recovered) from adverse events (AEs) due to a previously administered agent.
• Note: patients with any grade neuropathy or alopecia are an exception to this criterion and will qualify for the study.
• Note: if patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
• Active central nervous system (CNS) metastases. Patients with treated CNS metastases are permitted on study if all the following are true:

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Cholangiocarcinoma; Klatskin Tumor

Interventions

Biopsy; Specimen Handling; Magnetic Resonance Spectroscopy; sacituzumab govitecan

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Anup K Kasi Loknath Kumar

  University of Kansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2023
• First Posted: December 21, 2023
• Study Start: February 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

US (1)