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IMGN529 exposure: concentration decay and NCA references

Explore concentration decay from specified initial concentrations and constant loss rates. Published cycle-one exposure summaries are shown separately as reference data.

Safety, tolerability, and preliminary activity of IMGN529, a CD37-targeted antibody-drug conjugate, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: a dose-escalation, phase I study ↗

Investigational New Drugs

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How do the calibrated low- and high-dose exponential probes compare?

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Reported-summary initialization, 0.1 mg/kg context

Authored conditional exponential concentration decay from a specified initial concentration and fixed rate; not original patient PK, NCA recomputation or a structural TMDD fit.

0–504 hour

Scenario details

Reported-summary initialization, 0.1 mg/kg context

Authored conditional exponential concentration decay from a specified initial concentration and fixed rate; not original patient PK, NCA recomputation or a structural TMDD fit.

Readouts

Conditional plasma concentration · ug/mL
Fixed authored conditional quantity or reference input in the stated unit; not an independent observed patient endpoint.
Exposure (AUC) · h*ug/mL
Fixed authored conditional quantity or reference input in the stated unit; not an independent observed patient endpoint.
Modeled remaining AUC · h*ug/mL
Fixed authored conditional quantity or reference input in the stated unit; not an independent observed patient endpoint.
Assay quantitation ratio · dimensionless
Fixed authored conditional quantity or reference input in the stated unit; not an independent observed patient endpoint.

Study purpose

  • How do the model's key biological readouts change under reported-summary initialization, 0.1 mg/kg context?

Assumptions

  • Authored conditional concentration decay; no original individual PK, noncompartmental recomputation, population fit or clinical endpoint prediction.
  • Initial concentration is supplied by the selected preset. Nominal mg/kg dose is a context label, not an administered event or identified body-mass assignment.
  • The dose-curve coefficients are fixed authored interpolation inputs. Their legacy symbols do not establish mechanistic target-mediated clearance.
  • Concentration loss and C+loss=C0 use ug/mL, not eliminated drug mass. No source cohort-mean volume/clearance is assigned as a structural compartment.
  • Exposure and quantitation calculations follow the declared conditional backbone, including mathematical continuation below assay quantitation.
  • NCA mean/SD references are aggregate observations; absent SD cells are not zero variability and no population intervals are generated.

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Simulation time
h
h
504 → 168

Time between reported samples.

h
2 → 1

2 changes · Variation 1

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Biology

An authored conditional exponential backbone links specified initial concentrations and constant decay rates to exposure diagnostics. Aggregate cycle-one NCA summaries provide separate read-only reference information.

An authored conditional exponential backbone links specified initial concentrations and constant decay rates to exposure diagnostics. Aggregate cycle-one NCA summaries provide separate read-only reference information.

Model details

10 parameters · 4 states · 4 equations · 28 derived outputs

Classification & API access
Therapeutic
IMGN529 (naratuximab emtansine), Naratuximab
Modality
Antibody–drug conjugate (ADC)
Target
CD37 (source biological context, no binding state)
Disease / scope
Relapsed or refractory B-cell non-Hodgkin lymphoma
ParameterDefaultUnitDescription
Published plasma assay quantitation limitassay_lloq_ug_mL0.0199µg/mLFixed primary assay19.9ng/mL reference expressed in ug/mL.
Authored inverse exposure floorcalibrated_cl_linear_per_kg0.0006938154776056903L/h/kgFixed authored dose-curve coefficient; not an original estimated patient/population PK parameter.
Authored dose curve inverse exposure scalecalibrated_cl_tmdd_per_kg0.015284385920209661L/h/kgFixed authored dose-curve coefficient; not an original estimated patient/population PK parameter.
Authored dose curve concentration exponentcalibrated_cmax_power1.1163537122557567—Fixed authored dose-curve coefficient; not an original estimated patient/population PK parameter.
Authored concentration scale atcalibrated_cmax_scale25.904302667367148µg/mLFixed authored dose-curve coefficient; not an original estimated patient/population PK parameter.
Authored dose curve midpointcalibrated_ec50_mg_kg0.0818666062153864mg/kgFixed authored dose-curve coefficient; not an original estimated patient/population PK parameter.
Authored dose curve shape exponentcalibrated_hill1.7994395624422985—Fixed authored dose-curve coefficient; not an original estimated patient/population PK parameter.
Nominal source dose contextselected_dose_mg_kg1.4mg/kgFixed source-summary context or declared conditional branch input.
Aggregate nca half-life referenceselected_half_life_h24.9hFixed source-summary context or declared conditional branch input.
Authored branch selectoruse_exploratory_calibrated0—Fixed source-summary context or declared conditional branch input.

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