Trial · NCT03964727
Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors
NCT03964727, Phase 2, Active not recruiting, Gilead Sciences; results first posted 2026-01-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors. Trials, record NCT03964727. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03964727
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors
- NCT number
- NCT03964727
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 227 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Metastatic Solid Tumor
- Interventions
- Sacituzumab Govitecan-hziy
- First posted
- 2019-05-28
- Last updated
- 2026-04-28
- Other registries' IDs
- eudract:2019-000579-18
- Results first posted
- 2026-01-30
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment | Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years | ORR was defined as the percentage of participants who had the best overall response of either complete response (CR) or partial response (PR). Responses are based on the investigator-assessed tumor response using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria for each histologic cohort. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: \>30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. The ORR rate was calculated with a two-sided exact 95% CI using the Clopper-Pearson method. Percentages are rounded off. |
| Secondary | ORR According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment | Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years | ORR was defined as the percentage of participants who had the best overall response of either CR or PR. Responses are based on BICR assessment using RECIST 1.1 criteria for each histologic cohort. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: \>30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. The ORR rate was calculated with a two-sided exact 95% CI using the Clopper-Pearson method. |
| Secondary | Duration of Response (DOR) According to RECIST 1.1 by BICR Assessment | Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years | DOR was the date of the first evaluation showing documented response, either PR or CR, to date of the first progression of disease (PD) or death from any cause,whichever comes first. Response are according to RECIST 1.1 by BICR for each histological cohort. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal;PR: \>30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Disease progression was defined as an increase of \>20% in the sum of diameters of target lesions, taking as reference the smallest sum on study(this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of more than 5 mm or the appearance of ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. DOR was estimated using Kaplan-Meier estimate. The 95% CI was computed by Brookmeyer-Crowley method. |
| Secondary | Clinical Benefit Rate (CBR) According to RECIST 1.1 by BICR Assessment | Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years | CBR was percentage of participants with best overall response of CR, PR,or durable stable disease (SD) (SD ≥ 6 months after first dose). Responses are according to RECIST 1.1 by BICR.CR: Disappearance of all target and non-target lesions;\& normalization of tumor marker levels initially above upper limits of normal;PR:\>30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD. SD:Neither sufficient shrinkage for PR nor sufficient increase for PD, taking reference of smallest sum LD since treatment started or ≥ 1 non-target lesions with maintenance of tumor marker level above normal limits.PD: Increase of \>20% in sum of diameters of target lesions, taking reference of smallest sum(this includes baseline sum if smallest on study), the sum must also demonstrate an absolute increase of more than 5 mm or of ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. Two-sided CI was based on Clopper-Pearson method. |
| Secondary | Progression-free Survival (PFS) According to RECIST 1.1 by BICR Assessment | Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years | PFS was defined as the time from the first dose until objective tumor progression or death from any cause, whichever comes first. Responses are according to RECIST 1.1 by BICR. Disease progression was defined as an increase of \>20% in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of more than 5 mm or the appearance ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier estimate. The 95% CI for median was computed by Brookmeyer-Crowley method. |
| Secondary | DOR According to RECIST 1.1 by Investigator's Assessment | Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years | DOR was the date of the first evaluation showing documented response, either PR or CR, to date of the first PD or death from any cause, whichever comes first. Responses are based on investigator-assessed tumor response by RECIST 1.1 criteria for each histological cohort.CR:Disappearance of all target and non-target lesions;and normalization of tumor marker levels initially above upper limits of normal;PR:\>30% decrease in the sum of the LD of target lesions,taking as reference the baseline sum LD. Disease progression was defined as increase of \>20% in sum of diameters of target lesions, taking as reference the smallest sum on study(this includes the baseline sum if that is the smallest on study).In addition, the sum must also demonstrate an absolute increase of more than 5 mm or the appearance of ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. DOR was estimated using Kaplan-Meier estimate. The 95% CI was computed by Brookmeyer-Crowley method. |
| Secondary | CBR According to RECIST 1.1 by Investigator's Assessment | Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years | CBR was the percentage of participants with the best overall response of CR, PR,or durable SD (SD ≥ 6 months after first dose) by investigator-assessed tumor response using RECIST 1.1 criteria.CR:Disappearance of all target and non-target lesions;\& normalization of tumor marker levels initially above upper limits of normal;PR:\>30% decrease in sum of LD of target lesions,taking as reference the baseline sum LD. SD:Neither sufficient shrinkage for PR nor sufficient increase for PD,taking reference of smallest sum LD since treatment started or ≥ 1 non-target lesions with maintenance of tumor marker level above normal limits.PD: Increase of \>20% in sum of diameters of target lesions,taking reference of smallest sum(this includes baseline sum if smallest on study),the sum must also demonstrate an absolute increase of more than 5 mm or of ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions.Two-sided CI was based on Clopper-Pearson method. |
| Secondary | PFS According to RECIST 1.1 by Investigator's Assessment | Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years | PFS was defined as the time from the first dose until objective tumor progression or death from any cause, whichever comes first. Responses are based on the investigator-assessed tumor response using RECIST 1.1 criteria. Disease progression was defined as an increase of \>20% in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of more than 5 mm or the appearance ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier estimate. The 95% CI for median was computed by Brookmeyer-Crowley method. |
| Secondary | Overall Survival (OS) | Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years | OS was defined as the interval from the first dose date of drug to death from any cause. OS was estimated using Kaplan-Meier estimate. The 95% CI for median was computed by Brookmeyer-Crowley method. |
| Secondary | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | Up to 7.2 years | A TEAE was defined as any AE with an onset date on or after the study drug start date and no later than 30 days after last dose of study drug or the day before initiation of subsequent therapy, whichever comes first. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment | Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years | The Full Analysis Set included all participants who received at least 1 dose of SG. | percentage of participants | NUMBER |
| SECONDARY | ORR According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment | Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years | Participants in the Full Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) According to RECIST 1.1 by BICR Assessment | Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years | Participants in the Full Analysis Set who achieved confirmed CR or PR/with objective response were analyzed. | months | MEDIAN |
| SECONDARY | Clinical Benefit Rate (CBR) According to RECIST 1.1 by BICR Assessment | Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years | Participants in the Full Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) According to RECIST 1.1 by BICR Assessment | Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years | Participants in the Full Analysis Set were analyzed. | months | MEDIAN |
| SECONDARY | DOR According to RECIST 1.1 by Investigator's Assessment | Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years | Participants in the Full Analysis Set who achieved confirmed CR or PR/with objective response were analyzed. | months | MEDIAN |
| SECONDARY | CBR According to RECIST 1.1 by Investigator's Assessment | Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years | Participants in the Full Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | PFS According to RECIST 1.1 by Investigator's Assessment | Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years | Participants in the Full Analysis Set were analyzed. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years | Participants in the Full Analysis Set were analyzed. | months | MEDIAN |
| SECONDARY | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | Up to 7.2 years |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group306
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment | Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC] | 12.9 | 95% Confidence Interval 3.6 to 29.8 | percentage of participants | |
| Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment | Cohort 1 Group 2: NSCLC (Adenocarcinoma) | 5.9 | 95% Confidence Interval 0.7 to 19.7 | percentage of participants | |
| Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment | Cohort 1 Group 3: NSCLC (SCC) | 6.5 | 95% Confidence Interval 0.8 to 21.4 | percentage of participants | |
| Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment | Cohort 2: HNSCC | 16.3 | 95% Confidence Interval 6.8 to 30.7 | percentage of participants | |
| Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment | Cohort 3: EC | 26.8 | 95% Confidence Interval 14.2 to 42.9 | percentage of participants | |
| Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment | Cohort 4: ES-SCLC | 44.2 | 95% Confidence Interval 29.1 to 60.1 | percentage of participants | |
| ORR According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment | Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC] | 3.2 | 95% Confidence Interval 0.1 to 16.7 | percentage of participants | |
| ORR According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment | Cohort 1 Group 2: NSCLC (Adenocarcinoma) | 8.8 | 95% Confidence Interval 1.9 to 23.7 | percentage of participants | |
| ORR According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment | Cohort 1 Group 3: NSCLC (SCC) | 16.1 | 95% Confidence Interval 5.5 to 33.7 | percentage of participants | |
| ORR According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment | Cohort 2: HNSCC | 18.6 | 95% Confidence Interval 8.4 to 33.4 | percentage of participants |
1 to 10 of 306Source ClinicalTrials.gov
See all 306 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 Group 1: NSCLC [Adenocarcinoma + Squamous Cell Carcinoma (SCC)] | 31 | |
| Overall Study | STARTED | Cohort 1 Group 2: NSCLC (Adenocarcinoma) | 34 | |
| Overall Study | STARTED | Cohort 1 Group 3: NSCLC (SCC) | 31 | |
| Overall Study | STARTED | Cohort 2: Head And Neck Squamous Cell Carcinoma (HNSCC) | 43 | |
| Overall Study | STARTED | Cohort 3: Endometrial Cancer (EC) | 41 | |
| Overall Study | STARTED | Cohort 4: Extensive-Stage Small Cell Lung Cancer (ES-SCLC) | 43 | |
| Overall Study | COMPLETED | Cohort 1 Group 1: NSCLC [Adenocarcinoma + Squamous Cell Carcinoma (SCC)] | 0 | |
| Overall Study | COMPLETED | Cohort 1 Group 2: NSCLC (Adenocarcinoma) | 0 | |
| Overall Study | COMPLETED | Cohort 1 Group 3: NSCLC (SCC) | 0 | |
| Overall Study | COMPLETED | Cohort 2: Head And Neck Squamous Cell Carcinoma (HNSCC) | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events1,290
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC] | 9 | 31 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort 1 Group 2: NSCLC (Adenocarcinoma) | 12 | 34 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort 1 Group 3: NSCLC (SCC) | 6 | 31 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort 2: HNSCC | 13 | 43 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort 3: EC | 19 | 41 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort 4: ES-SCLC | 13 | 43 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC] | 1 | 31 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Cohort 1 Group 2: NSCLC (Adenocarcinoma) | 4 | 34 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Cohort 1 Group 3: NSCLC (SCC) | 1 | 31 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Cohort 2: HNSCC | 1 | 43 |
1 to 10 of 1,290Source ClinicalTrials.gov
See all 1,290 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC] | 26 | 31 |
| Total, all-cause mortality | Cohort 1 Group 2: NSCLC (Adenocarcinoma) | 27 | 34 |
| Total, all-cause mortality | Cohort 1 Group 3: NSCLC (SCC) | 28 | 31 |
| Total, all-cause mortality | Cohort 2: HNSCC | 35 | 43 |
| Total, all-cause mortality | Cohort 3: EC | 30 | 41 |
| Total, all-cause mortality | Cohort 4: ES-SCLC | 32 | 43 |
| Total, other adverse events | Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC] | 30 | 31 |
| Total, other adverse events | Cohort 1 Group 2: NSCLC (Adenocarcinoma) | 34 | 34 |
| Total, other adverse events | Cohort 1 Group 3: NSCLC (SCC) | 30 | 31 |
| Total, other adverse events | Cohort 2: HNSCC | 43 | 43 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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GET https://conductscience.org/api/trials/v1/NCT03964727
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