Description:
The primary objective of this study is to to assess the objective response rate (ORR) of
sacituzumab govitecan-hziy in adult participants with metastatic solid tumors.
Title
- Brief Title: Study of Sacituzumab Govitecan-hziy in Metastatic Solid Tumors
- Official Title: A Phase 2 Open Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
IMMU-132-11
- NCT ID:
NCT03964727
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Sacituzumab Govitecan-hziy | IMMU-132 | Sacituzumab Govitecan-hziy |
Purpose
The primary objective of this study is to to assess the objective response rate (ORR) of
sacituzumab govitecan-hziy in adult participants with metastatic solid tumors.
Trial Arms
Name | Type | Description | Interventions |
---|
Sacituzumab Govitecan-hziy | Experimental | Participants with non-small cell lung cancer (NSCLC), head and neck squameous cell carcinoma (HNSCC), or endometrial cancer will receive sacituzumab govitecan-hziy 10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle until disease progression (PD), toxicity or withdrawal of consent. | - Sacituzumab Govitecan-hziy
|
Eligibility Criteria
Key Inclusion Criteria:
- Able to understand and give written informed consent.
- Individuals with the following histologically documented metastatic (M1, Stage IV) or
locally advanced solid tumors. Tumor blocks (preferably, obtained within 12 months of
study entry if clinically feasible) or 20 newly sectioned slides (6 minimum) of
archived biopsy/surgical specimens are requested. these specimens should be submitted
within 28 days before initiating Screening, after the individual provides written
informed consent. A baseline biopsy is required if archival tissue is not available.
Fine needle aspirations and bone biopsies are not suitable samples.
- Non-small cell lung cancer (NSCLC) (adenocarcinoma or squamous cell carcinoma
(SCC)), that has progressed after prior platinum-based chemotherapy and
Programmed death-ligand 1 (PD-L1) or Programmed cell death protein 1 (PD-1)
directed therapy; recurrence/ relapse or lack of response within 6 months of
completion of chemotherapy for locally advanced disease, that line of therapy may
be counted for eligibility.
- Incurable, recurrent, or metastatic HNSCC that has progressed after prior
platinum based chemotherapy and PD-LI or PD-1 directed therapy
- Relapsed unresectable endometrial cancer that has progressed after prior platinum
based chemotherapy or is refractory to platinum based chemotherapy
- Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1
- Adequate hematologic counts without transfusional or growth factor support within 2
weeks of study drug initiation
- Adequate hepatic function
- Individual must have at least a 3-month life expectancy
- Have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging
(MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Tumor
lesions situated in a previously irradiated area may be utilized if they are
considered measurable and progression has been demonstrated in such lesions.
Key Exclusion Criteria:
- Have had a prior anti-cancer biologic agent within 4 weeks prior to study Day 1 or
have had prior chemotherapy, targeted small molecule therapy, radiation therapy within
2 weeks prior to Study Day 1
- Have not recovered (i.e., ≤ Grade 1) from adverse events due to a previously
administered agent
- Have previously received topoisomerase I inhibitors
- Have an active second malignancy
- Have known active central nervous system (CNS) metastases and/or carcinomatous
meningitis. Individuals with previously treated brain metastases may participate
provided they have stable CNS disease for at least 4 weeks prior to the first dose of
study drug and all neurologic symptoms have returned to baseline, have no evidence of
new or enlarging brain metastases and are taking ≤20 mg/day of prednisone or its
equivalent. All individuals with carcinomatous meningitis are excluded regardless of
clinical stability
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment |
Time Frame: | Up to end of treatment (average 3 years) |
Safety Issue: | |
Description: | ORR, is defined as the rate of the overall best response, complete response (CR) or partial response (PR), based on the investigator-assessed tumor response using RECIST 1.1 criteria. |
Secondary Outcome Measures
Measure: | Overall Response Rate (ORR) According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment |
Time Frame: | Up to end of treatment (average 3 years) |
Safety Issue: | |
Description: | ORR, is defined as the rate of the overall best response, CR or PR, by BICR using RECIST 1.1 criteria |
Measure: | Duration of Response (DOR) According to RECIST 1.1 by BICR |
Time Frame: | Up to end of treatment (average 3 years) |
Safety Issue: | |
Description: | DOR, is calculated as the date of the first evaluation showing documented response, either PR or CR, to the date of the first progression of disease (PD) or death according to RECIST 1.1 by BICR |
Measure: | Clinical Benefit Rate (CBR) According to RECIST 1.1 by BICR |
Time Frame: | Up to end of treatment (average 3 years) |
Safety Issue: | |
Description: | CBR is defined as CR + PR + stable disease (SD) according to RECIST 1.1 by BICR |
Measure: | Progression-free Survival (PFS) According to RECIST 1.1 by BICR |
Time Frame: | Up to end of treatment (average 3 years) |
Safety Issue: | |
Description: | PFS, is defined as the time from first dose until objective tumor progression or death, whichever comes first according to RECIST 1.1 by BICR |
Measure: | DOR According to RECIST 1.1 by Investigator's Assessment |
Time Frame: | Up to end of treatment (average 3 years) |
Safety Issue: | |
Description: | DOR, is calculated as the date of the first evaluation showing documented response, either PR or CR, to the date of the first PD or death based on the investigator-assessed tumor response using RECIST 1.1 criteria |
Measure: | Clinical Benefit Rate (CBR) According to RECIST 1.1 by Investigator's Assessment |
Time Frame: | Up to end of treatment (average 3 years) |
Safety Issue: | |
Description: | CBR, is defined as CR + PR + SD based on the investigator-assessed tumor response using RECIST 1.1 criteria |
Measure: | Progression-free Survival (PFS) According to RECIST 1.1 by Investigator's Assessment |
Time Frame: | Up to end of treatment (average 3 years) |
Safety Issue: | |
Description: | PFS, is defined as the time from first dose until objective tumor progression or death, whichever comes first according to RECIST 1.1 based on the investigator-assessed tumor response using RECIST 1.1 criteria |
Measure: | Trophoblast Cell-surface Antigen-2 (TROP-2) Expression Level |
Time Frame: | Up to end of treatment (average 3 years) |
Safety Issue: | |
Description: | |
Measure: | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) |
Time Frame: | First dose date up to last dose date plus 30 days (average 3 years) |
Safety Issue: | |
Description: | |
Measure: | Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) |
Time Frame: | First dose date up to last dose date plus 30 days (average 3 years) |
Safety Issue: | |
Description: | |
Measure: | Percentage of Participants Experiencing any Clinically Significant Laboratory Abnormalities |
Time Frame: | First dose date up to last dose date plus 30 days (average 3 years) |
Safety Issue: | |
Description: | |
Measure: | Pharmacokinetic (PK) Parameter: Cmax of Sacituzumab Govitecan-hziy |
Time Frame: | First dose date up to last dose date plus 30 days (average 3 years) |
Safety Issue: | |
Description: | Cmax is defined as the maximum observed concentration of drug. |
Measure: | Pharmacokinetic (PK) Parameter: AUC0-168h of Sacituzumab Govitecan-hziy |
Time Frame: | First dose date up to last dose date plus 30 days (average 3 years) |
Safety Issue: | |
Description: | AUC0-168h is defined as the concentration of drug over time between time 0 and time 168 hours |
Measure: | Pharmacokinetic (PK) Parameter: Tmax of Sacituzumab Govitecan-hziy |
Time Frame: | First dose date up to last dose date plus 30 days (average 3 years) |
Safety Issue: | |
Description: | Tmax is defined as time to maximum observed concentration (Cmax) |
Measure: | Immunogenicity Assessment |
Time Frame: | First dose date up to last dose date plus 30 days (average 3 years) |
Safety Issue: | |
Description: | Number of participants who test positive for anti-drug antibodies to sacituzumab govitecan-hziy will be reported. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Gilead Sciences |
Last Updated
August 20, 2021