Advanced Solid TumorsPhase 1NCT06167317
Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors
A Phase 1 study testing GS-0201 and Sacituzumab Govitecan in people with Advanced Solid Tumors, run by Gilead Sciences at 8 sites in 2 countries.
Trial summary
The main goal of this first in human (FIH) study is to learn about the safety and dosing of GS-0201 when given alone or in combination with sacituzumab govitecan (SG) in participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- GS-0201 and Sacituzumab Govitecan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 9 Jan 2024to Sep 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and give written informed consent.
- Assigned female or male at birth, 18 years of age or older, and meet the age of majority/adulthood per local regulations.
- 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.
- Organ function requirements:
- Adequate hematologic function
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- Adequate hepatic function
- Creatinine clearance
- Coagulation
- Tissue requirement:
- Parts A, B, C, and D:
- Pre-treatment tumor tissue is required.
- Parts A and C backfill biopsy cohorts:
- Individuals must agree to fresh pre- and on-treatment biopsies.
- Individuals assigned male at birth and individuals assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception
- Willing and able to comply with the requirements and restrictions in this protocol
- Part A (GS-0201 Monotherapy Dose Escalation) Inclusion Criteria:
- Histologically/cytologically confirmed progressive/advanced solid tumors with selected molecular lesions.
- Individuals must have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit or have a contraindication to receive the therapy
- Part B (Dose Expansion) Inclusion Criteria:
- Disease documented as:
- Cohort B1:
- Histologically or cytologically confirmed progressive/advanced selected solid tumor diagnoses harboring defined molecular lesions
- Participants may potentially be required to forgo treatment with approved agent(s) to be able to participate in the study
- Cohort B2:
- Histologically or cytologically confirmed progressive/advanced solid tumor diagnoses harboring defined molecular lesions not included in Cohort B1
- Part C (Dose Escalation) Inclusion Criteria:
- Histologically or cytologically confirmed unresectable locally advanced/metastatic selected solid tumors
- Part D (Dose Expansion) Inclusion Criteria:
- Disease documented as:
- Cohort D1:
- Histologically or cytologically confirmed unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC)
- Cohort D2:
- Recurrent/persistent endometrial cancer
Who cannot join
- Pregnant or lactating females
- Known hypersensitivity to any of the study drugs, its metabolites, or formulation excipients
- Requirement for ongoing therapy with or use of any prohibited medications described in the protocol
- Individuals with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with findings suggestive of MDS/AML
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of GS-0201
- The therapies listed below within the specified timeframe:
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- Major surgery (excluding minor procedures, eg, placement of vascular access, gastrointestinal/biliary stent, biopsy) < 4 weeks prior to planned Cycle 1 Day 1
- Immunotherapy or biologic therapy < 21 days prior to planned Cycle 1 Day 1
- Chemotherapy < 14 days prior to planned Cycle 1 Day 1, or < 42 days for mitomycin or nitrosoureas
- Targeted small molecule therapy < 14 days prior to planned Cycle 1 Day 1
- Receipt of experimental therapy within 21 days or 5 experimental treatment half-lives (whichever is longer) prior to planned Cycle 1 Day 1
- Hormonal or other adjunctive therapy for cancers other than the cancer under evaluation in this study that started < 14 days prior to planned Cycle 1 Day 1 are not permitted. Hormonal therapy, bisphosphonates, somatostatin analogues, and leuprolide are permitted if started ≥ 14 days prior to planned Cycle 1 Day 1
- Radiotherapy within 2 weeks prior to planned Cycle 1 Day 1 and the radiation is not administered to a target lesion
- Any prior allogeneic tissue/solid organ transplantation, including allogeneic hematopoietic stem cell transplantation. Individuals with a history of autologous hematopoietic stem cell transplantation are also excluded
- Have not recovered (ie, Grade 1 or lower) from AEs due to a previously administered agent
- Prior treatment with approved or experimental prohibited agents as detailed in the protocol.
- Diagnosis of immunodeficiency, either primary or acquired, or requires systemic corticosteroids (> 10 mg of prednisone daily, or equivalent). However, replacement doses, topical, ophthalmologic, and inhalational steroids are permitted
- Have an active second malignancy
- Have known active central nervous system (CNS) metastases
- Individuals with carcinomatous meningitis or primary CNS tumors are excluded regardless of clinical stability
- Meet any of the following criteria for cardiac disease:
- Myocardial infarction or unstable angina pectoris within 6 months of enrollment
- History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication)
- QT interval > 470 msec
- New York Heart Association Class III or greater congestive heart failure or known left ventricular ejection fraction less than 40%
- Meet any of the following infectious criteria:
- Have active serious infection requiring antimicrobials
- Have active hepatitis B virus (HBV) or hepatitis C virus (HCV), or HIV. In individuals with a history of HBV or HCV, individuals with detectable viral loads will be excluded
- Individuals who test positive for hepatitis B surface antigen. Individuals who test positive for hepatitis B core antibody are eligible with a negative HBV DNA by quantitative Polymerase chain reaction (PCR)
- Individuals who test positive for HCV antibody. Individuals who test positive for HCV antibody are eligible with a negative HCV RNA by quantitative PCR
- Individuals who test positive for HIV antibody
- History of pneumonitis requiring treatment with corticosteroids, interstitial lung disease, or radiation pneumonitis requiring steroids
- Symptomatic ascites or pleural effusion
- 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
- Any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the individuals participation in the study
- Use of any live vaccines against infectious diseases within 4 weeks (28 days) of initiation of study drug(s) (inactivated, viral vector vaccines, and messenger RNA (mRNA) vaccines are allowed; seasonal vaccines should be up to date prior to planned Cycle 1 Day 1)
- Parts C (Dose Escalation) and D (Dose Expansion): Combination Cohorts:
- Individuals with active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease) and individuals with a history of bowel obstruction or gastrointestinal perforation within 6 months prior to planned Cycle 1 Day 1
- Individuals who previously received topoisomerase 1 inhibitors or antibody-drug conjugates containing a topoisomerase 1 inhibitor
- Known severe intolerance or life-threatening hypersensitivity reactions to humanized monoclonal antibodies or intravenous (IV) immunoglobulin preparations; any history of anaphylaxis; history of human anti-human antibody response
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Gilead Clinical Study Information Center contact
8 sites in 2 countries
United States5 sites, 5 recruiting
- Recruiting
NEXT Austin
Austin, Texas, 78758
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02459
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
NEXT Dallas
Irving, Texas, 75039
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Israel3 sites, 3 recruiting
- Recruiting
Rambam Health Care Campus
Haifa, 31096
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
- Recruiting
Chaim Sheba Medical Center
Tel HaShomer, 52621
About this study
Official title: A Phase 1 Study to Evaluate the Safety and Tolerability of GS-0201 as Monotherapy and in Combination in Adults With Advanced Solid Tumors
The main goal of this first in human (FIH) study is to learn about the safety and dosing of GS-0201 when given alone or in combination with sacituzumab govitecan (SG) in participants with advanced solid tumors.
The primary objectives of this study are to:
- To assess the safety and tolerability of GS-0201 as monotherapy and in combination with SG in participants with selected advanced solid tumors
- To identify the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of GS-0201 as monotherapy and the MTD and/or the RP2D and dosing schedule of GS-0201 in combination with SG in participants with selected advanced solid tumors
- Conditions
- Advanced Solid Tumors
- Being tested
- GS-0201, Sacituzumab Govitecan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-0201Drug
Pill administered orally
Sacituzumab GovitecanDrug
Also called IMMU-132, Trodelvy™, GS-0132
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Part A: GS-0201 Monotherapy Dose Escalation | Experimental | 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. Receives: Drug: GS-0201 |
| Part B: Cohort B1: GS-0201 Monotherapy Dose Expansion | Experimental | Participants with selected breast cancer indication will receive GS-0201 monotherapy at the recommended dose for expansion. Receives: Drug: GS-0201 |
| Part B: Cohort B2: GS-0201 Monotherapy Dose Expansion | Experimental | Participants with selected indications not included in cohort B1 will receive GS-0201 monotherapy at the recommended dose for expansion. Receives: Drug: GS-0201 |
| Part C: Dose Escalation: GS-0201 + Sacituzumab Govitecan (SG) | Experimental | 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. Receives: Drug: GS-0201; Drug: Sacituzumab Govitecan |
| Part D: Cohort D1: Dose Expansion: GS-0201 + SG | Experimental | 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. Receives: Drug: GS-0201; Drug: Sacituzumab Govitecan |
| Part D: Cohort D2: Dose Expansion: GS-0201 + SG | Experimental | Participants with recurrent/persistent endometrial cancer will receive GS-0201 at the recommended Phase 2 dose (RP2D) in combination with SG. Receives: Drug: GS-0201; Drug: Sacituzumab Govitecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants with Dose Limiting Toxicities (DLTs) During Dose Escalation
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.
Measured: First dose up to 30 days post last dose (Up to approximately 109 weeks).
The Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: First dose up to 30 days post last dose (Up to approximately 109 weeks).
The Incidence of Laboratory Abnormalities
Measured: First dose up to 30 days post last dose (Up to approximately 109 weeks).
Secondary outcomes (8)
Pharmacokinetic (PK) Parameter: Area Under the Concentration (AUC)0-24 of GS-0201
AUC0-24 is defined as the concentration of drug over time between time 0 and time 24 hours.
Measured: Predose and postdose up to end of treatment (up to 105 weeks)
PK Parameter: Cmax of GS-0201
Cmax is defined as the maximum observed drug concentration.
Measured: Predose and postdose up to end of treatment (up to 105 weeks)
PK Parameter: Tmax of GS-0201
Tmax is defined as the time to maximum observed concentration.
Measured: Predose and postdose up to end of treatment (up to 105 weeks)
PK Parameter: AUC0-168 of SG (Parts C and D only)
AUC0-168 is defined as the concentration of drug over time between time 0 and time 168 hours.
Measured: Predose and postdose up to end of treatment (up to 105 weeks)
PK Parameter: Cmax of SG (Parts C and D only)
Cmax is defined as the maximum observed drug concentration.
Measured: Predose and postdose up to end of treatment (up to 105 weeks)
PK Parameter: Tmax of SG (Parts C and D only)
Tmax is defined as the time to maximum observed concentration.
Measured: Predose and postdose up to end of treatment (up to 105 weeks)
GS-0201 Plasma Concentrations
Measured: Predose and postdose up to end of treatment (up to 105 weeks)
Sacituzumab Govitecan (SG) Serum Concentrations (Parts C and D only)
Measured: Predose and postdose up to end of treatment (up to 105 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start9 Jan 2024
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 278 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167317
- Sponsor's protocol ID
- GS-US-686-6854
- Status last verified
- Aug 2026
- First submitted
- 4 Dec 2023
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety and Tolerability of GS-0201 as Monotherapy and in Combination in Adults With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06167317
- Acronym / sponsor ID
- GS-US-686-6854
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of this first in human (FIH) study is to learn about the safety and dosing of GS-0201 when given alone or in combination with sacituzumab govitecan (SG) in participants with advanced solid tumors.
The primary objectives of this study are to:
- To assess the safety and tolerability of GS-0201 as monotherapy and in combination with SG in participants with selected advanced solid tumors
- To identify the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of GS-0201 as monotherapy and the MTD and/or the RP2D and dosing schedule of GS-0201 in combination with SG in participants with selected advanced solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A: GS-0201 Monotherapy Dose Escalation | Experimental | Drug: GS-0201Participants 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. |
| Part B: Cohort B1: GS-0201 Monotherapy Dose Expansion | Experimental | Drug: GS-0201Participants with selected breast cancer indication will receive GS-0201 monotherapy at the recommended dose for expansion. |
| Part B: Cohort B2: GS-0201 Monotherapy Dose Expansion | Experimental | Drug: GS-0201Participants with selected indications not included in cohort B1 will receive GS-0201 monotherapy at the recommended dose for expansion. |
| Part C: Dose Escalation: GS-0201 + Sacituzumab Govitecan (SG) | Experimental | Drug: GS-0201, Drug: Sacituzumab GovitecanParticipants 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. |
| Part D: Cohort D1: Dose Expansion: GS-0201 + SG | Experimental | Drug: GS-0201, Drug: Sacituzumab GovitecanParticipants 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. |
| Part D: Cohort D2: Dose Expansion: GS-0201 + SG | Experimental | Drug: GS-0201, Drug: Sacituzumab GovitecanParticipants with recurrent/persistent endometrial cancer will receive GS-0201 at the recommended Phase 2 dose (RP2D) in combination with SG. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- Able to understand and give written informed consent.
- Assigned female or male at birth, 18 years of age or older, and meet the age of majority/adulthood per local regulations.
- 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.
- Organ function requirements:
Key exclusion criteria (41 listed)
- Pregnant or lactating females
- Known hypersensitivity to any of the study drugs, its metabolites, or formulation excipients
- Requirement for ongoing therapy with or use of any prohibited medications described in the protocol
- Individuals with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with findings suggestive of MDS/AML
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of GS-0201
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GS-0201Pill administered orally | Drug | Part A: GS-0201 Monotherapy Dose Escalation, Part B: Cohort B1: GS-0201 Monotherapy Dose Expansion, Part B: Cohort B2: GS-0201 Monotherapy Dose Expansion, Part C: Dose Escalation: GS-0201 + Sacituzumab Govitecan (SG), Part D: Cohort D1: Dose Expansion: GS-0201 + SG, Part D: Cohort D2: Dose Expansion: GS-0201 + SG |
| Sacituzumab GovitecanAlso: IMMU-132, Trodelvy™, GS-0132Administered intravenously | Drug | Part C: Dose Escalation: GS-0201 + Sacituzumab Govitecan (SG), Part D: Cohort D1: Dose Expansion: GS-0201 + SG, Part D: Cohort D2: Dose Expansion: GS-0201 + SG |
Primary outcome
The Number of Participants with Dose Limiting Toxicities (DLTs) During Dose Escalation
Time frame: 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.
The Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: First dose up to 30 days post last dose (Up to approximately 109 weeks).
The Incidence of Laboratory Abnormalities
Time frame: First dose up to 30 days post last dose (Up to approximately 109 weeks).
8 secondary outcomes
Pharmacokinetic (PK) Parameter: Area Under the Concentration (AUC)0-24 of GS-0201
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
PK Parameter: Cmax of GS-0201
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
PK Parameter: Tmax of GS-0201
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
PK Parameter: AUC0-168 of SG (Parts C and D only)
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
PK Parameter: Cmax of SG (Parts C and D only)
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
PK Parameter: Tmax of SG (Parts C and D only)
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
GS-0201 Plasma Concentrations
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Sacituzumab Govitecan (SG) Serum Concentrations (Parts C and D only)
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gilead Clinical Study Information Center contact
Gilead Study Director study director
Gilead Sciences
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GS-0201 and Sacituzumab Govitecan in people with Advanced Solid Tumors, run by Gilead Sciences at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 34 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gilead Clinical Study Information Center (1-833-445-3230 (GILEAD-0), GileadClinicalTrials@gilead.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Participants with Dose Limiting Toxicities (DLTs) During Dose Escalation (time frame: First dose up to 30 days post last dose (Up to approximately 109 weeks).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.