Trial · NCT06167317
Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors
NCT06167317, Phase 1, Recruiting, Gilead Sciences
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors. Trials, record NCT06167317. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06167317
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors
- NCT number
- NCT06167317
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 278 participants, estimated
- Lead sponsor
- Gilead Sciences
- Conditions
- Advanced Solid Tumors
- Interventions
- GS-0201, Sacituzumab Govitecan
- First posted
- 2023-12-12
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Participants with Dose Limiting Toxicities (DLTs) During Dose Escalation | First dose up to 30 days post last dose (Up to approximately 109 weeks). | DLTs are defined as any of the following treatment-emergent adverse events (AEs) regardless of attribution (graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0), unless clearly related to an underlying disease or extraneous causes, with onset within the DLT-evaluation period for the corresponding dose. |
| Primary | The Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | First dose up to 30 days post last dose (Up to approximately 109 weeks). | |
| Primary | The Incidence of Laboratory Abnormalities | First dose up to 30 days post last dose (Up to approximately 109 weeks). | |
| Secondary | Pharmacokinetic (PK) Parameter: Area Under the Concentration (AUC)0-24 of GS-0201 | Predose and postdose up to end of treatment (up to 105 weeks) | AUC0-24 is defined as the concentration of drug over time between time 0 and time 24 hours. |
| Secondary | PK Parameter: Cmax of GS-0201 | Predose and postdose up to end of treatment (up to 105 weeks) | Cmax is defined as the maximum observed drug concentration. |
| Secondary | PK Parameter: Tmax of GS-0201 | Predose and postdose up to end of treatment (up to 105 weeks) | Tmax is defined as the time to maximum observed concentration. |
| Secondary | PK Parameter: AUC0-168 of SG (Parts C and D only) | Predose and postdose up to end of treatment (up to 105 weeks) | AUC0-168 is defined as the concentration of drug over time between time 0 and time 168 hours. |
| Secondary | PK Parameter: Cmax of SG (Parts C and D only) | Predose and postdose up to end of treatment (up to 105 weeks) | Cmax is defined as the maximum observed drug concentration. |
| Secondary | PK Parameter: Tmax of SG (Parts C and D only) | Predose and postdose up to end of treatment (up to 105 weeks) | Tmax is defined as the time to maximum observed concentration. |
| Secondary | GS-0201 Plasma Concentrations | Predose and postdose up to end of treatment (up to 105 weeks) |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06167317
GET https://conductscience.org/api/trials/v1/NCT06167317/registered