NCT02669017 · OUTCOME

Recommended Dose of ADCT-402 for Part 2

Study of ADCT-402 in Patients With Relapsed or Refractory B-cell Lineage Non Hodgkin Lymphoma (B-NHL) · Source last updated 2021-05-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: μg/kg
Interval / dispersion: Not reported
Time frame: Q3W schedule: Day 1 to End of Cycle 1 (3 weeks); Q6W schedule: Day 1 to End of Cycle 1 (6 weeks)

What was measured

The recommended dose was established by the dose escalation steering committee and based on safety findings during Part 1 of the study.

Analysis population: All participants in Part 1 who completed at least one cycle of treatment.

Groups in this outcome

Part 1: ADCT-402 Dose Escalation

In Part 1 (dose escalation) participants received intravenous (IV) infusions of ADCT-402, at escalating doses according to a 3+3 study design. Doses assessed: * Dose Level 1: 15 μg/kg on Day 1 of each 3 week cycle (Q3W) * Dose Level 2: 30 μg/kg Day 1 Q3W * Dose Level 3: 60 μg/kg Day 1 Q3W * Dose Level 4: 90 μg/kg Day 1 Q3W * Dose Level 5: 120 μg/kg Day 1 Q3W * Dose Level 6: 150 μg/kg Day 1 Q3W * Dose Level 7: 200 μg/kg Day 1 Q3W and on Day 1 of each 6 week cycle (Q6W).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Part 1: ADCT-402 Dose Escalation	73

Reported measurements

Recommended Part 2 Dose 1

Values in μg/kg · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: ADCT-402 Dose Escalation	120	Not reported	Not reported	Not reported	Not reported

Recommended Part 2 Dose 2

Values in μg/kg · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: ADCT-402 Dose Escalation	150	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
120
title
Recommended Part 2 Dose 1
categories
measurements
group Id
OG000
value
150
title
Recommended Part 2 Dose 2

denoms

counts
group Id
OG000
value
73
units
Participants

description

The recommended dose was established by the dose escalation steering committee and based on safety findings during Part 1 of the study.

groups

description
In Part 1 (dose escalation) participants received intravenous (IV) infusions of ADCT-402, at escalating doses according to a 3+3 study design. Doses assessed: * Dose Level 1: 15 μg/kg on Day 1 of each 3 week cycle (Q3W) * Dose Level 2: 30 μg/kg Day 1 Q3W * Dose Level 3: 60 μg/kg Day 1 Q3W * Dose Level 4: 90 μg/kg Day 1 Q3W * Dose Level 5: 120 μg/kg Day 1 Q3W * Dose Level 6: 150 μg/kg Day 1 Q3W * Dose Level 7: 200 μg/kg Day 1 Q3W and on Day 1 of each 6 week cycle (Q6W).
id
OG000
title
Part 1: ADCT-402 Dose Escalation

param Type

NUMBER

population Description

All participants in Part 1 who completed at least one cycle of treatment.

reporting Status

POSTED

time Frame

Q3W schedule: Day 1 to End of Cycle 1 (3 weeks); Q6W schedule: Day 1 to End of Cycle 1 (6 weeks)

title

Recommended Dose of ADCT-402 for Part 2

type

PRIMARY

unit Of Measure

μg/kg

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice