A Phase 1 interventional study of Dalutrafusp alfa and mFOLFOX6 Regimen in Advanced Solid Tumors, sponsored by Gilead Sciences. Terminated at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-21.
Sponsored by Gilead Sciences · Phase 1, Interventional, and Treatment
For Phase 1a Part A, the primary objectives are to assess safety and tolerability and to define the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of dalutrafusp alfa (formerly GS-1423) monotherapy in participants with advanced solid tumors.
For Phase 1a Part B, the primary objective is to assess safety and tolerability of dalutrafusp alfa monotherapy in participants with advanced solid tumors.
For Phase 1b Cohort 1 safety run-in, the primary objective is to assess safety and tolerability and to define the DLT and MTD or RP2D of dalutrafusp alfa in combination with a chemotherapy regimen in participants with advanced gastric or gastroesophageal junction adenocarcinoma.
For Phase 1b Cohort 1 post safety run-in, the primary objective is to assess the preliminary efficacy of dalutrafusp alfa in combination with a chemotherapy regimen in participants with advanced gastric or gastroesophageal junction adenocarcinoma, as assessed by the confirmed objective response rate (ORR).
For Phase 1b Cohort 2, the primary objective is to assess safety and tolerability of dalutrafusp alfa monotherapy in participants with advanced solid tumors.
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Browse Neoplasms studies →Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.
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Key Inclusion Criteria:
Diagnosis:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Part A will consist of dose escalation by an accelerated dosing design and a 3+3 dose escalation scheme. Participants will receive escalating dose levels dalutrafusp alfa of up to 45 mg/kg on Day 1 of each 2-week cycle (Q2W) until the participant meets study treatment discontinuation criteria or for up to 1 year.
Drug: Dalutrafusp alfa
Part B will consist of 3 adaptive cohorts. Based on PK, pharmacodynamics, and safety results from the Part A study, participants will be administered a flat dose of dalutrafusp alfa on Day 1 of each cycle QW, Q2W and/or every 3 weeks (Q3W) until the participant meets study treatment discontinuation criteria or for up to 1 year.
Drug: Dalutrafusp alfa
Safety run-in: A standard 3+3 dose escalation design will be used to determine the DLT and MTD or RP2D of dalutrafusp alfa in combination with mFOLFOX6. The planned starting dose of dalutrafusp alfa will be targeted to achieve the exposure at -1 dose of RP2D monotherapy (Q2W) determined from Phase 1a. Dalutrafusp alfa will be administered in combination with mFOLFOX6. Post safety run-in: Approximately 70 participants will be enrolled to receive dalutrafusp alfa at the dose level determined from the safety run-in period, in combination with mFOLFOX6 regimen. Participants will receive dalutrafusp alfa on Day 1 of each 14-day cycle up to 2 years until PD, or unacceptable toxicity, substantial noncompliance with study procedures or study drug, study discontinuation or withdrawal from study. Participants will also receive mFOLFOX6 regimen Q2W for up to 12 cycles.
Drug: Dalutrafusp alfa · Drug: mFOLFOX6 Regimen
Participants will receive dalutrafusp alfa at the dose level determined from Phase 1a Q2W until the participants meets study treatment discontinuation criteria or for up to 1 year.
Drug: Dalutrafusp alfa
Administered intravenously
Also known as: GS-1423
Chemotherapy regimen of oxaliplatin, 5-fluorouracil \[5-FU\], and leucovorin
Administered intravenously
Also known as: GS-1423
Phase 1a Part A: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs), Graded Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
DLT was defined as: Grade 3 thrombocytopenia with bleeding; Grade ≥ 3 febrile neutropenia; any Grade 4 hematologic laboratory abnormalities/adverse events (AEs) (except Grade 4 lymphopenia and anaemia, Grade 4 neutropenia lasting ≤ 7 days with no fever); Grade 4 non-hematologic AEs; any ≥Grade 2 uveitis, blurred vision, eye pain, and/or reduction of visual acuity that did not respond to topical therapy and did not improve to Grade 1 severity within 2 weeks of topical therapy initiation or required systemic treatment; Grade 3 non-hematologic AEs; any other non-immune-related Grade 3 AE (except any Grade 3 endocrinopathy; Grade 3 AE of tumor flare; transient \[≤ 3 days\] Grade 3 fatigue, local reactions, headache, nausea, emesis, or diarrhea and/or resolved to Grade ≤ 1; transient Grade 3 flu-like symptoms or fever); inability to receive first 2 doses of GS-1423 or \> 2-week delay in starting next cycle of therapy due to a treatment-related toxicity; Grade 5 event (death).
Time frame: Baseline up to 28 days
Phase 1a Part A: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
An AE was any untoward medical occurrence in a participant administered the study drug, which did not necessarily have a causal relationship with the treatment. An AE could therefore, be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Adverse events might also include pretreatment or posttreatment complications that occurred as a result of protocol-specified procedures or special situations. Preexisting events that increased in severity or change in nature during or as a consequence of participation in the study were also considered AEs. TEAEs were AEs with onset dates on or after the first dose of study drug GS-1423 and up to 30 days after permanent withdrawal of GS-1423.
Time frame: First dose date up to permanent withdrawal of GS-1423 (maximum duration: 26.3 weeks) plus 30 days
Phase 1a Part A: Percentage of Participants With Treatment-Emergent Grade 3 or 4 Laboratory Abnormalities
Severity was graded per NCI CTCAE v5.0. Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening or disabling, Grade 5: Death related to AE.
Time frame: First dose date up to permanent withdrawal of GS-1423 (maximum duration: 26.3 weeks) plus 30 days
Phase 1a Part A: Percentage of Participants With Shift in Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) From Baseline to Overall Study
The Baseline value was the last available value collected on or prior to first dose of study drug. Percentages were based on participants with values available at both baseline and postbaseline. NCS = Non-clinical significance; CS = Clinical significance.
Time frame: First dose date up to permanent withdrawal of GS-1423 (maximum duration: 26.3 weeks) plus 30 days
Phase 1a Part A: Pharmacokinetic (PK) Parameter: AUCtau of GS-1423
AUCtau was defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Time frame: Cycle 1 and Cycle 4: Day 1 (Predose, end of infusion, 2 and 6 hours post start of infusion); Days 2, 3, 5, and 8 (additionally at Day 15 in Cycle 4)
Phase 1a Part A: Percentage of Participants Who Developed Anti-Drug Antibodies (ADAs)
Time frame: Baseline, during the treatment (maximum duration: 26.3 weeks), Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 4 Day 15, Cycle 6 Day 1, 30-day follow-up (30 days after discontinuation of GS-1423), post treatment follow-up (3 months)
Participants were enrolled at study sites in United States. The first participant was screened on 03 June 2019. The last study visit occurred on 15 April 2021.
| Milestone | Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg | Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg | Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg | Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg | Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg | Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg | Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg |
|---|---|---|---|---|---|---|---|
| Started | 1 | 1 | 3 | 3 | 3 | 8 | 3 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 1 | 1 | 3 | 3 | 3 | 8 | 3 |
| Withdrew: Death | 1 | 1 | 1 | 3 | 2 | 2 | 0 |
| Withdrew: Withdrew consent | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Study terminated by sponsor | 0 | 0 | 1 | 0 | 1 | 4 | 2 |
| Withdrew: Enrolled but not treated | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
DLT was defined as: Grade 3 thrombocytopenia with bleeding; Grade ≥ 3 febrile neutropenia; any Grade 4 hematologic laboratory abnormalities/adverse events (AEs) (except Grade 4 lymphopenia and anaemia, Grade 4 neutropenia lasting ≤ 7 days with no fever); Grade 4 non-hematologic AEs; any ≥Grade 2 uveitis, blurred vision, eye pain, and/or reduction of visual acuity that did not respond to topical therapy and did not improve to Grade 1 severity within 2 weeks of topical therapy initiation or required systemic treatment; Grade 3 non-hematologic AEs; any other non-immune-related Grade 3 AE (except any Grade 3 endocrinopathy; Grade 3 AE of tumor flare; transient \[≤ 3 days\] Grade 3 fatigue, local reactions, headache, nausea, emesis, or diarrhea and/or resolved to Grade ≤ 1; transient Grade 3 flu-like symptoms or fever); inability to receive first 2 doses of GS-1423 or \> 2-week delay in starting next cycle of therapy due to a treatment-related toxicity; Grade 5 event (death).
| percentage of participants | Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg | Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg | Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg | Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg | Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg | Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg | Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg |
|---|---|---|---|---|---|---|---|
| Phase 1a Part A: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs), Graded Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
An AE was any untoward medical occurrence in a participant administered the study drug, which did not necessarily have a causal relationship with the treatment. An AE could therefore, be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Adverse events might also include pretreatment or posttreatment complications that occurred as a result of protocol-specified procedures or special situations. Preexisting events that increased in severity or change in nature during or as a consequence of participation in the study were also considered AEs. TEAEs were AEs with onset dates on or after the first dose of study drug GS-1423 and up to 30 days after permanent withdrawal of GS-1423.
| percentage of participants | Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg | Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg | Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg | Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg | Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg | Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg | Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg |
|---|---|---|---|---|---|---|---|
| Phase 1a Part A: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
Severity was graded per NCI CTCAE v5.0. Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening or disabling, Grade 5: Death related to AE.
| percentage of participants | Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg | Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg | Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg | Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg | Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg | Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg | Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg |
|---|---|---|---|---|---|---|---|
| Hematology | 0 | 100.0 | 0 | 0 | 33.3 | 14.3 | 0 |
| Serum Chemistry | 0 | 0 | 0 | 33.3 | 33.3 | 14.3 | 0 |
| Coagulation | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Endocrine Function Tests | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Urinalysis | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
The Baseline value was the last available value collected on or prior to first dose of study drug. Percentages were based on participants with values available at both baseline and postbaseline. NCS = Non-clinical significance; CS = Clinical significance.
| percentage of participants | Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg | Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg | Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg | Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg | Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg | Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg | Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg |
|---|---|---|---|---|---|---|---|
| Normal baseline - Normal | 0 | 0 | 33.3 | 33.3 | 0 | 0 | 0 |
| Normal baseline - Abnormal NCS | 0 | 0 | 0 | 33.3 | 66.7 | 71.4 | 0 |
| Normal baseline - Abnormal CS | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Abnormal NCS Baseline - Normal | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Abnormal NCS Baseline - Abnormal NCS | 100.0 | 100.0 | 66.7 | 33.3 | 33.3 | 28.6 | 100.0 |
| Abnormal NCS Baseline - Abnormal CS | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Abnormal CS Baseline - Normal | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Abnormal CS Baseline - Abnormal NCS | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Abnormal CS Baseline - Abnormal CS | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
AUCtau was defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
| µg*h/mL | Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg | Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg | Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg | Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg | Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg | Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg | Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg |
|---|---|---|---|---|---|---|---|
| Cycle 1 | — | — | 1476.9 ± 759.84 | 5311.8 ± 595.77 | 33530.9 ± 1646.22 | 51593.2 ± 16313.20 | 64856.3 ± 9814.95 |
| Cycle 4 | — | — | 1711.9 ± 1486.08 | — | 28558.0 | 65368.1 ± 5469.82 | 74097.0 |
| percentage of participants | Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg | Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg | Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg | Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg | Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg | Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg | Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg |
|---|---|---|---|---|---|---|---|
| Baseline | 0 | 0 | 0 | 0 | 0 | 14.3 | 0 |
| During the Treatment | 100.0 | 0 | 66.7 | 66.7 | 66.7 | 0 | 33.3 |
| Cycle 2 Day 1 | 0 | 0 | 0 | 66.7 | 33.3 | 0 | 33.3 |
| Cycle 3 Day 1 | 0 | 0 | 33.3 | 33.3 | 66.7 | 0 | 0 |
| Cycle 4 Day 1 | 0 | 0 | 33.3 | 0 | 33.3 | 0 | 0 |
| Cycle 4 Day 15 | 0 | 0 | 0 | 0 | 33.3 | 0 | 0 |
| Cycle 6 Day 1 | 0 | 0 | 33.3 | 0 | 0 | 0 | 0 |
| 30-Day Follow-Up | 100.0 | 0 | 0 | 0 | 33.3 | 0 | 0 |
| Post Treatment Follow-Up (3 months) | 0 | 0 | 0 | 0 | 33.0 | 0 | 0 |
Collected over Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg | 1/1 (100%) | 0/1 (0%) | 1/1 (100%) |
| Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg | 1/1 (100%) | 1/1 (100%) | 1/1 (100%) |
| Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg | 1/3 (33.3%) | 0/3 (0%) | 3/3 (100%) |
| Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg | 3/3 (100%) | 2/3 (66.7%) | 3/3 (100%) |
| Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg | 2/3 (66.7%) | 2/3 (66.7%) | 3/3 (100%) |
| Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg | 2/8 (25%) | 4/7 (57.1%) | 7/7 (100%) |
| Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Event | Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg | Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg | Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg | Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg | Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg | Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg | Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg |
|---|---|---|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 0/1 | 1/1 | 0/3 | 0/3 | 0/3 | 0/7 | 0/3 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/1 | 1/1 | 0/3 | 0/3 | 0/3 | 0/7 | 0/3 |
| Abdominal painGastrointestinal disorders | 0/1 | 0/1 | 0/3 | 1/3 | 0/3 | 0/7 | 0/3 |
| VomitingGastrointestinal disorders | 0/1 | 0/1 | 0/3 | 1/3 | 0/3 | 0/7 | 0/3 |
| Disease progressionGeneral disorders | 0/1 | 0/1 | 0/3 | 1/3 | 0/3 | 0/7 | 0/3 |
| FatigueGeneral disorders | 0/1 | 0/1 | 0/3 | 1/3 | 0/3 | 0/7 | 0/3 |
| Tumour painNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/1 | 0/1 | 0/3 | 0/3 | 1/3 | 0/7 | 0/3 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 0/1 | 0/1 | 0/3 | 0/3 | 1/3 | 1/7 | 0/3 |
| Aortic embolusVascular disorders | 0/1 | 0/1 | 0/3 | 1/3 | 0/3 | 0/7 | 0/3 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/1 | 0/1 | 0/3 | 0/3 | 0/3 | 1/7 | 0/3 |
| Event | Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg | Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg | Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg | Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg | Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg | Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg | Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg |
|---|---|---|---|---|---|---|---|
| Abdominal distensionGastrointestinal disorders | 0/1 | 1/1 | 0/3 | 0/3 | 1/3 | 0/7 | 0/3 |
| Abdominal painGastrointestinal disorders | 1/1 | 0/1 | 0/3 | 2/3 | 1/3 | 0/7 | 0/3 |
| ConstipationGastrointestinal disorders | 0/1 | 1/1 | 0/3 | 1/3 | 0/3 | 0/7 | 0/3 |
| DiarrhoeaGastrointestinal disorders | 0/1 | 1/1 | 2/3 | 0/3 | 1/3 | 2/7 | 0/3 |
| NauseaGastrointestinal disorders | 0/1 | 1/1 | 1/3 | 1/3 | 0/3 | 2/7 | 2/3 |
| FatigueGeneral disorders | 0/1 | 1/1 | 1/3 | 1/3 | 2/3 | 4/7 | 0/3 |
| PyrexiaGeneral disorders | 0/1 | 1/1 | 1/3 | 0/3 | 1/3 | 1/7 | 0/3 |
| Alanine aminotransferase increasedInvestigations | 1/1 | 0/1 | 0/3 | 0/3 | 0/3 | 1/7 | 0/3 |
| Aspartate aminotransferase increasedInvestigations | 1/1 | 0/1 | 0/3 | 0/3 | 0/3 | 1/7 | 0/3 |
| Lymphocyte count decreasedInvestigations | 1/1 | 0/1 | 0/3 | 1/3 | 0/3 | 0/7 | 0/3 |
The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
| Age, Continuous(years) | Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg | Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg | Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg | Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg | Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg | Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg | Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | 58 | 67 | 70 ± 8.7 | 70 ± 11.6 | 62 ± 7.4 | 57 ± 15.8 | 71 ± 7.2 | 64 ± 12.0 |
| Sex: Female, Male(Participants) | Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg | Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg | Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg | Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg | Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg | Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg | Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 0 | 1 | 3 | 2 | 2 | 6 | 1 | 15 |
| Male | 1 | 0 | 0 | 1 | 1 | 1 | 2 | 6 |
| Ethnicity (NIH/OMB)(Participants) | Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg | Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg | Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg | Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg | Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg | Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg | Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg | Total |
|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 | 3 | 2 | 5 | 2 | 14 |
| Not Hispanic or Latino | 1 | 0 | 1 | 0 | 0 | 2 | 0 | 4 |
| Unknown or Not Reported | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 3 |
| Race (NIH/OMB)(Participants) | Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg | Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg | Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg | Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg | Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg | Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg | Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg | Total |
|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 3 |
| White | 1 | 1 | 3 | 3 | 2 | 5 | 3 | 18 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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