ArticleDrug design, development and therapy2025
Population Pharmacokinetic and Pharmacodynamic Modeling Analysis of rhIL-7-hyFc, a Hybrid Fc-Fused Long-Acting Interleukin-7, to Support Optimal Dosing Regimens in Patients with Solid Cancer.
Article in Drug design, development and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03478995 (A Phase 1b, Open Label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GX-I7 in Patients With Locally Advanced or Metastatic Solid Tumors), which is not on this map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 1b, Open Label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GX-I7 in Patients With Locally Advanced or Metastatic Solid Tumors
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose: rhIL-7-hyFc (Efineptakin alfa) is a novel, long-acting recombinant human interleukin-7 developed to enhance immune responses by correcting T-cell deficiencies through increased lymphocyte counts. This study aimed to develop a population pharmacokinetic-pharmacodynamic (PK-PD) model to support selection of the recommended Phase 2 dose (RP2D) through optimization of dosing regimens. Patients and Methods: Serum rhIL-7-hyFc concentrations and absolute lymphocyte counts (ALC) were collected from 35 patients with solid tumors enrolled in a Phase Ib clinical trial (NCT03478995), who received multiple intramuscular administrations of rhIL-7-hyFc at doses ranging from 0.06 to 1.7 mg/kg every 3 or 6 weeks. A sequential mixed-effects PK-PD model was developed using NONMEM Results: The PK data were best described by a two-compartment model with first-order absorption from two depot compartments, and inter-occasional variability in clearance was incorporated in the final model. To account for the time-delayed response, the PD model utilized a series of transit compartments representing lymphocyte maturation. The stimulatory effect of rhIL-7-hyFc on progenitor cell proliferation was described using a simple maximum effect model. The estimated half-maximum effective concentration (EC Conclusion: A population PK-PD modeling and simulation results demonstrated a strong exposure-response relationship for ALC across dosing intervals, underscoring the mechanism-based therapeutic potential of rhIL-7-hyFc in cancer immunotherapy.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.