NCT05397171 · OUTCOME

Number of Participants With Dose Limiting Toxicity (DLT)

A First-in-human Study to Evaluate the Safety and Tolerability of AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours · Source last updated 2024-10-01

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: From Cycle 1 Day 1 to end of Cycle 1 (21 days)

What was measured

DLTs (in dose escalation Parts only) of AZD8853 in participants with selected advanced/metastatic solid tumors was assessed. The DLTs are specific adverse events defined as grade 3 (severe), grade 4 (life-threatening), and grade 5 (death) as per NCI-CTCAE version 5.0 non-hematological toxicity or hematological toxicity. This outcome measure was assessed only for substudy 1 Part A.

Analysis population: DLT evaluable set included enrolled participants who completed the DLT evaluation period (defined as 21 days after receiving the first infusion of IP) with at least 75% dosing and had completed safety evaluation requirements during the DLT evaluation period.

Groups in this outcome

AZD8853 300 mg

Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.

AZD8853 1000 mg

Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.

AZD8853 3000 mg

Participants with advanced/metastatic solid tumors received AZD8853 3000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.

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
AZD8853 300 mg	3
AZD8853 1000 mg	6
AZD8853 3000 mg	6

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
AZD8853 300 mg	Not reported	Not reported	Not reported	Not reported
AZD8853 1000 mg	Not reported	Not reported	Not reported	Not reported
AZD8853 3000 mg	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
6
group Id
OG002
value
6
units
Participants

description

groups

description
Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
id
OG000
title
AZD8853 300 mg
description
Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
id
OG001
title
AZD8853 1000 mg
description
Participants with advanced/metastatic solid tumors received AZD8853 3000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
id
OG002
title
AZD8853 3000 mg

param Type

COUNT_OF_PARTICIPANTS

population Description

DLT evaluable set included enrolled participants who completed the DLT evaluation period (defined as 21 days after receiving the first infusion of IP) with at least 75% dosing and had completed safety evaluation requirements during the DLT evaluation period.

reporting Status

POSTED

time Frame

From Cycle 1 Day 1 to end of Cycle 1 (21 days)

title

Number of Participants With Dose Limiting Toxicity (DLT)

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice