Metastatic Solid Tumors
Conditions
Keywords
ADC, Antibody-Drug Conjugate, Trop-2, SN-38
Brief summary
The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy (SG), and how safe it is in participants with metastatic cancer (cancer that has spread).
Detailed description
This is a rollover study. Only participants who continue to receive clinical benefit from continuation of SG therapy and are tolerating therapy at the time of enrollment are eligible for this study. Participants enrolled may continue to receive SG at the dose that they were receiving in the Gilead parent study at the time of consenting to participate in this rollover study.
Interventions
DRUGSacituzumab Govitecan-hiy
Administered intravenously
Sponsors
Gilead Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Receiving ongoing treatment with sacituzumab govitecan in a Gilead (previously Immunomedics)-sponsored parent study. * Continuing to receive clinical benefit from sacituzumab govitecan-hziy therapy. Key
Exclusion criteria
* Females who are pregnant or lactating. * Initiated therapy with another cancer therapeutic agent since receiving last dose of study drug on the parent study in which they participated. * Experienced a toxicity from sacituzumab govitecan-hziy that resulted in permanent discontinuation of therapy. * Have other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations. Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Experiencing Any Adverse Events | First dose date up to 30 days post last dose (Up to 3.9 years) | An adverse event was defined as any untoward medical occurrence in a participant administered a medicinal product that does not necessarily have a causal relationship with this treatment. |
| Percentage of Participants Experiencing Any Serious Adverse Events | First dose date up to 30 days post last dose (Up to 3.9 years) | A serious adverse event (SAE) was any untoward medical occurrence that, at any dose, was fatal (resulting in death), was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. |
| Percentage of Participants Experiencing Any Grade and Grade 3 or 4 Laboratory Abnormalities | First dose date up to 30 days post last dose (Up to 3.9 years) | The percentage of participants experiencing any clinically significant laboratory abnormality was summarized. |
Countries
Belgium, France, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in the United States, Belgium and France.
Pre-assignment details
27 participants were screened. Participants must have been enrolled in other Gilead (previously Immunomedics)-sponsored studies of SG to be eligible to receive continued access to SG in this study.
Participants by arm
| Arm | Count |
|---|---|
| Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01) All participants who previously received SG in the parent study (IMMU-132-01) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until progressive disease (PD), toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years. | 3 |
| Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05) All participants who previously received SG in the parent study (IMMU-132-05) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years. | 10 |
| Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-15) All participants who previously received SG in the parent study (IMMU-132-15) continued to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years. | 12 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Events Resolution or Stabilization | 3 | 4 | 0 |
| Overall Study | Death | 0 | 3 | 3 |
| Overall Study | Reason Not Specified | 0 | 2 | 4 |
| Overall Study | Site Terminated by Sponsor | 0 | 1 | 0 |
| Overall Study | Withdrawal of Consent | 0 | 0 | 5 |
Baseline characteristics
| Characteristic | Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01) | Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05) | Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-15) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 2 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 8 Participants | 10 Participants | 18 Participants |
| Age, Continuous | 71 years STANDARD_DEVIATION 5.7 | 61 years STANDARD_DEVIATION 10.4 | 49 years STANDARD_DEVIATION 15.5 | 56 years STANDARD_DEVIATION 14.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 10 Participants | 8 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 7 Participants | 9 Participants | 19 Participants |
| Region of Enrollment Belgium | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Region of Enrollment France | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 3 Participants | 7 Participants | 12 Participants | 22 Participants |
| Sex: Female, Male Female | 3 Participants | 10 Participants | 8 Participants | 21 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 4 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 3 / 10 | 3 / 12 |
| other Total, other adverse events | 2 / 3 | 10 / 10 | 11 / 12 |
| serious Total, serious adverse events | 0 / 3 | 4 / 10 | 1 / 12 |
Outcome results
Primary
Percentage of Participants Experiencing Any Adverse Events
An adverse event was defined as any untoward medical occurrence in a participant administered a medicinal product that does not necessarily have a causal relationship with this treatment.
Time frame: First dose date up to 30 days post last dose (Up to 3.9 years)
Population: Participants from All Treated Participants Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01) | Percentage of Participants Experiencing Any Adverse Events | 66.7 percentage of participants |
| Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05) | Percentage of Participants Experiencing Any Adverse Events | 100.0 percentage of participants |
| Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-15) | Percentage of Participants Experiencing Any Adverse Events | 91.7 percentage of participants |
Primary
Percentage of Participants Experiencing Any Grade and Grade 3 or 4 Laboratory Abnormalities
The percentage of participants experiencing any clinically significant laboratory abnormality was summarized.
Time frame: First dose date up to 30 days post last dose (Up to 3.9 years)
Population: Participants from All Treated Participants Analysis Set with at least 1 grade change postbaseline were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01) | Percentage of Participants Experiencing Any Grade and Grade 3 or 4 Laboratory Abnormalities | Any Grade 1 or Higher Laboratory Abnormalities | 100.0 percentage of participants |
| Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01) | Percentage of Participants Experiencing Any Grade and Grade 3 or 4 Laboratory Abnormalities | Grade 3 or 4 Laboratory Abnormalities | 33.3 percentage of participants |
| Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05) | Percentage of Participants Experiencing Any Grade and Grade 3 or 4 Laboratory Abnormalities | Any Grade 1 or Higher Laboratory Abnormalities | 88.9 percentage of participants |
| Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05) | Percentage of Participants Experiencing Any Grade and Grade 3 or 4 Laboratory Abnormalities | Grade 3 or 4 Laboratory Abnormalities | 44.4 percentage of participants |
| Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-15) | Percentage of Participants Experiencing Any Grade and Grade 3 or 4 Laboratory Abnormalities | Any Grade 1 or Higher Laboratory Abnormalities | 81.8 percentage of participants |
| Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-15) | Percentage of Participants Experiencing Any Grade and Grade 3 or 4 Laboratory Abnormalities | Grade 3 or 4 Laboratory Abnormalities | 72.7 percentage of participants |
Primary
Percentage of Participants Experiencing Any Serious Adverse Events
A serious adverse event (SAE) was any untoward medical occurrence that, at any dose, was fatal (resulting in death), was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.
Time frame: First dose date up to 30 days post last dose (Up to 3.9 years)
Population: Participants from All Treated Participants Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01) | Percentage of Participants Experiencing Any Serious Adverse Events | 0 percentage of participants |
| Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05) | Percentage of Participants Experiencing Any Serious Adverse Events | 40.0 percentage of participants |
| Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-15) | Percentage of Participants Experiencing Any Serious Adverse Events | 8.3 percentage of participants |