18 and older, any sex, with Advanced Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Parts 1 and 2: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)Primary· Part 1: Day 1 through Day 28; Part 2: Day 1 through Day 21
DLT was defined as any toxicity (hematologic, non-hematologic, dosing/procedures-related toxicities, or grade 5 event (ie death)) occurring with GS-3583 monotherapy during the DLT assessment period (from Day 1 up to Day 28) considered at least possibly related to GS-3583 monotherapy.
Group
Value
95% CI
Part 1: Cohort 2: GS-3583 2000 μg
0
Part 1: Cohort 3: GS-3583 6000 μg
0
Part 1: Cohort 4: GS-3583 12000 μg
0
Part 1: Cohort 5: GS-3583 20000 μg
0
Parts 1 and 2: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0Primary· First dose date up to last dose date plus 90 days (Up to 4 months)
TEAEs were AEs with onset dates on or after the first dose and up to 90 days after the date of the last dose of study treatment or the day before initiation of subsequent therapy, whichever occurred first. TEAEs severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. Participants were counted at the highest AE grade experienced.
Group
Value
95% CI
Part 1: Cohort 2: GS-3583 2000 μg
100
Part 1: Cohort 3: GS-3583 6000 μg
100
Part 1: Cohort 4: GS-3583 12000 μg
100
Part 1: Cohort 5: GS-3583 20000 μg
100
Parts 1 and 2: Percentage of Participants With Laboratory Abnormalities According to the NCI CTCAE Version 5.0Primary· First dose date up to last dose date plus 90 days (Up to 4 months)
A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time, up to 90 days after the last dose of study drug or the day before initiation of subsequent therapy, whichever occurred first. A treatment-emergent laboratory abnormality severity was graded according to the NCI CTCAE version 5.0. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. Participants were counted at the highest AE grade experienced.
Group
Value
95% CI
Part 1: Cohort 2: GS-3583 2000 μg
100
Part 1: Cohort 3: GS-3583 6000 μg
100
Part 1: Cohort 4: GS-3583 12000 μg
100
Part 1: Cohort 5: GS-3583 20000 μg
100
Parts 1 and 2: Percentage of Participants With GS-3583 Anti-drug Antibodies (ADAs) at Any VisitPrimary· Cycles 1and 3,pre-dose,End of Infusion (EOI);2,6 hours;Days 2,3,5,8,15 post Day 1EOI;Day 15:Cycle 1:predose and EOI;2 hours post EOI;Cycle 3:336 hours and Day 24 post EOI(Cycle length = 28 days in Part 1; 21 days for Part 2;infusion duration=60 minutes)
Participants were monitored for the development of ADAs throughout their treatment period with GS-3583 and at the end of study.
Group
Value
95% CI
Part 1: Cohort 2: GS-3583 2000 μg
33.3
Part 1: Cohort 3: GS-3583 6000 μg
33.3
Part 1: Cohort 4: GS-3583 12000 μg
0
Part 1: Cohort 5: GS-3583 20000 μg
0
Part 1: Pharmacokinetic (PK) Parameter: AUCtau of GS-3583Secondary· Cycles 1 and 3, pre-dose, EOI; 2, 6 hours; Days 2, 3, 5, 8, 15 post Day 1 EOI; Day 15:Cycle 1:predose and EOI; 2 hours post EOI;Cycle 3:336 hours and Day 24 post EOI (Cycle length for all cycles=28 days in Part 1; Infusion duration=60 minutes)
AUCtau is defined as the area under the concentration versus time curve over the dosing interval where tau = 15 days.
Cycle 1
Group
Value
95% CI
Part 1: Cohort 2: GS-3583 2000 μg
82100
± 19900
Part 1: Cohort 3: GS-3583 6000 μg
249000
± 124000
Part 1: Cohort 4: GS-3583 12000 μg
352000
± 41300
Part 1: Cohort 5: GS-3583 20000 μg
832000
± 223000
Part 1: PK Parameter: Cmax of GS-3583Secondary· Cycles 1 and 3,pre-dose,EOI;2, 6 hours;Days 2, 3, 5, 8, 15 post Day 1 EOI;Day 15:Cycle 1:predose and EOI;2 hours post EOI;Cycle 3:336 hours and Day 24 post EOI (Cycle length for all cycles=28 days in Part 1;Infusion duration=60 minutes)
Cmax is defined as the maximum observed plasma concentration.
Cycle 1
Group
Value
95% CI
Part 1: Cohort 2: GS-3583 2000 μg
643
± 36.3
Part 1: Cohort 3: GS-3583 6000 μg
1860
± 562
Part 1: Cohort 4: GS-3583 12000 μg
2520
± 244
Part 1: Cohort 5: GS-3583 20000 μg
5800
± 1460
Part 1: PK Parameter: Tmax of GS-3583Secondary· Cycles 1 and 3, pre-dose, EOI; 2, 6 hours; Days 2, 3, 5, 8, 15 post Day 1 EOI; Day 15:Cycle 1:predose and EOI; 2 hours post EOI; Cycle 3:336 hours and Day 24 post EOI (Cycle length for all cycles=28 days in Part 1; infusion duration=60 minutes)
Tmax is defined as the time to reach maximum observed plasma concentration (Tmax).
Cycle 1
Group
Value
95% CI
Part 1: Cohort 2: GS-3583 2000 μg
1.1
1.0 – 1.1
Part 1: Cohort 3: GS-3583 6000 μg
2.0
1.1 – 5.6
Part 1: Cohort 4: GS-3583 12000 μg
1.1
1.1 – 2.0
Part 1: Cohort 5: GS-3583 20000 μg
1.7
1.2 – 2.1
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 14.8 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study is planned to be conducted in 2 parts: Part 1: Dose Escalation and Part 2: Safety Run-In and Randomized Expansion.
The primary objectives of Part 1 are 1) To characterize the safety and tolerability of GS-3583 as monotherapy in participants with advanced solid tumors. 2) To determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of GS-3583 as monotherapy in participants with advanced solid tumors.
The primary objectives of Part 2 is to assess the safety and tolerability and to determine the RP2D of GS-3583 in combination with zimberelimab (ZIM) and platinum (cisplatin or carboplatin) + 5-fluorouracil (5-FU) chemotherapy in participants with head and neck squamous cell carcinoma (HNSCC) (Cohort A) or in combination with docetaxel in participants with non-small cell lung cancer (NSCLC) (Cohort B).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07414316 — A Single-Arm, Open-Label Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors.
· EARLY_PHASE1
· recruiting
NCT07222969 — A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors
· Phase 1, PHASE2
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gilead Sciences
Last refreshed: 3 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04747470.