A Phase 1 interventional study of LVGN6051 and Pembrolizumab in Cancer, sponsored by Lyvgen Biopharma Holdings Limited. Completed at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-19.
Sponsored by Lyvgen Biopharma Holdings Limited · Phase 1, Interventional, and Treatment
The study of LVGN6051-201 is designed to use a bridging dose escalation to quickly establish the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RDE) as well as the recommended Phase 2 dose(s) (RP2D) of LVGN6051, both as a single agent (monotherapy) and in combination with a fixed dose of anti-PD-1 antibody (Pembrolizumab) in the treatment of advanced or metastatic malignancy.
Based on the dose escalation results from the study of LVGN6051-101, a bridging dose escalation (3+3) is used in study of LVGN6051-201. The traditional 3 + 3 dose escalation algorithm to identify the MTD and/or RDE and RP2D of LVGN6051 as a single agent (monotherapy) and in combination with pembrolizumab. The first stage of the study is the single agent dose escalation and expansion phase (Part A). The second stage of the study is the combination dose escalation and expansion phase (Part B). Patients will be considered evaluable for safety and tolerability if they receive at least one dose of LVGN6051 or pembrolizumab at the specified cohort dose. Patients in all parts of the trial will remain on therapy until confirmed disease progression or for 2 years, whichever occurs first. However, patients who are clinically unstable will discontinue following the initial assessment of disease progression
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 18 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Lyvgen Biopharma Holdings Limited is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
LVGN6051 monotherapy dose escalation
Drug: LVGN6051
LVGN6051 dose expansion cohorts
Drug: LVGN6051
LVGN6051 in combination with anti-PD-1 antibody pembrolizumab dose escalation
Drug: LVGN6051 · Drug: Pembrolizumab
LVGN6051 in combination with anti-PD-1 antibody pembrolizumab dose expansion cohorts
Drug: LVGN6051 · Drug: Pembrolizumab
Route of administration is IV infusion, and the frequency of administration is once every 3 weeks (Q3W). one cycle is 3 weeks, and treatment can be up to 35 cycles if patients receive benefits.
Route of administration is IV infusion, and the frequency of administration is once every 3 weeks (Q3W). one cycle is 3 weeks, and treatment can be up to 35 cycles if patients receive benefits.
Treatment-emergent adverse events (TEAEs) including determination of DLTs and serious AEs (SAEs)
Adverse events will be assessed, and severity will be assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Time frame: up to 24 months
MTD or RDE or RP2D
maximal tolerated dose, recommended dose for expansion or recommended phase 2 dose
Time frame: up to 24 months
DCR
DCR will be documented as the proportion of patients with best overall response of CR, PR, or stable disease (SD). DCR per RECIST v1.1, iRECIST, and Cheson/Lugano criteria.
Time frame: up to 24 months
PK parameter AUC
Area under the serum concentration versus time curve (AUC) will be determined.
Time frame: up to 24 months
PK parameter Cmax
Peak Plasma Concentration (Cmax) will be summarized.
Time frame: up to 24 months
PK parameter t1/2
Serum concentration half-life t1/2 will be summarized.
Time frame: up to 24 months
ADA to LVGN6051
The presence of ADA directed against LVGN6051 will be determined.
Time frame: up to 24 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Lyvgen Biopharma Holdings Limited