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Part B: Cohort B2: GS-0201 Monotherapy Dose Expansion for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.

Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria by investigator assessment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first dose up to 30 days post last dose (up to approximately 109 weeks).

Awards & highlights

Study Summary

This trial aims to study the safety and dosage of GS-0201, either alone or in combination with sacituzumab govitecan, in patients with advanced solid tumors. The main objectives

Who is the study for?

This trial is for adults with advanced solid tumors who are physically capable of daily activity (ECOG status 0-1). They must understand the study and consent to it, have good blood, kidney, liver function, and measurable tumor growth. Participants need to provide tissue samples before and during treatment.Check my eligibility

What is being tested?

The trial tests GS-0201 alone or combined with sacituzumab govitecan (SG) in treating advanced solid tumors. It aims to find out the safest dose that can be given without severe side effects (MTD) and suggest a Phase 2 dose.See study design

What are the potential side effects?

Potential side effects include reactions at the infusion site, changes in blood counts leading to increased infection risk or bleeding problems, liver or kidney issues due to drug toxicity, fatigue, nausea, and other common chemotherapy-related symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My cancer can be measured by standard criteria.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first dose up to 30 days post last dose (up to approximately 109 weeks).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first dose up to 30 days post last dose (up to approximately 109 weeks).

This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose up to 30 days post last dose (up to approximately 109 weeks). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The Incidence of Laboratory Abnormalities

The Number of Participants with Dose Limiting Toxicities (DLTs) During Dose Escalation

The Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Secondary outcome measures

GS-0201 Plasma Concentrations

PK Parameter: AUC0-168 of SG (Parts C and D only)

PK Parameter: Cmax of GS-0201

+5 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: Part D: Cohort D2: Dose Expansion: GS-0201 + SGExperimental Treatment2 Interventions

Participants with confirmed unresectable locally advanced or metastatic HR+/HER2- breast cancer will receive GS-0201 at the recommended Phase 2 dose (RP2D) in combination with SG.

Group II: Part D: Cohort D1: Dose Expansion: GS-0201 + SGExperimental Treatment2 Interventions

Participants with confirmed unresectable locally advanced or metastatic triple negative breast cancer (mTNBC) will receive GS-0201 at the recommended Phase 2 dose (RP2D) in combination with SG.

Group III: Part C: Dose Escalation: GS-0201 + Sacituzumab Govitecan (SG)Experimental Treatment2 Interventions

Participants will receive escalating doses of GS-0201 in combination with SG, until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol or up to 105 weeks, whichever occurs first.

Group IV: Part B: Cohort B2: GS-0201 Monotherapy Dose ExpansionExperimental Treatment1 Intervention

Participants with selected indications not included in cohort B1 will receive GS-0201 monotherapy at the recommended dose for expansion.

Group V: Part B: Cohort B1: GS-0201 Monotherapy Dose ExpansionExperimental Treatment1 Intervention

Participants with selected indications will receive GS-0201 monotherapy at the recommended dose for expansion.

Group VI: Part A: GS-0201 Monotherapy Dose EscalationExperimental Treatment1 Intervention

Participants will receive escalating doses of GS-0201 monotherapy, until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol or up to 105 weeks, whichever occurs first.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Gilead SciencesLead Sponsor

1,084 Previous Clinical Trials

848,231 Total Patients Enrolled

Gilead Study DirectorStudy DirectorGilead Sciences

343 Previous Clinical Trials

186,445 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants still eligible to enroll in this ongoing clinical trial?

"Indeed, based on the information available on clinicaltrials.gov, this study is actively seeking eligible participants. The trial was initially posted for recruitment purposes on January 1st, 2024 and underwent its most recent update on January 5th, 2024."

Answered by AI

How large is the patient cohort enrolled in this medical study?

"Indeed, the information available on clinicaltrials.gov confirms that this ongoing clinical trial is actively seeking participants. The trial was initially posted on January 1st, 2024 and last updated on January 5th, 2024. The study aims to enroll a total of 248 patients from two designated sites."

Answered by AI

What are the potential risks associated with Part B: Cohort B2: GS-0201 Monotherapy Dose Expansion for individuals undergoing treatment?

"Given that this trial is in Phase 1, the safety rating for Part B: Cohort B2: GS-0201 Monotherapy Dose Expansion is estimated to be a 1. This indicates limited data supporting both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors

2024. "Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06167317.