NCT04628780 · OUTCOME

Number of Participants With Dose Limiting Toxicities (DLTs)

Study to Test the Safety and Tolerability of PF-07209960 in Advanced or Metastatic Solid Tumors · Source last updated 2024-07-29

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: Cycle 1 (28 days)

What was measured

For the purpose of dose escalation, any of the following adverse events were classified as DLTs: Occur in the first cycle of treatment, or within 28 days after the start of the study treatment; and were at least possibly related to PF-07209960; A participant was classified as DLT evaluable if he/she experienced a DLT or if he/she otherwise in the absence of a DLT received 2 doses of the study intervention during Cycle 1 and had received all scheduled safety assessments during the DLT window. If a participant failed to meet these criteria, he/she might be replaced. Monitoring for DLTs occurred during Part 1.

Analysis population: The DLT analysis set was a subset of the safety analysis set. A participant was classified as DLT-evaluable if he/she experienced a DLT or received 100% of the planned doses and had received all scheduled safety assessments during the DLT window.

Groups in this outcome

PF-07209960 1 mg SC

Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.

PF-07209960 3 mg SC

Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.

PF-07209960 10 mg SC

Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.

PF-07209960 15 mg SC

Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.

PF-07209960 20 mg SC

Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.

PF-07209960 30 mg SC

Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.

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
PF-07209960 1 mg SC	4
PF-07209960 3 mg SC	3
PF-07209960 10 mg SC	4
PF-07209960 15 mg SC	2
PF-07209960 20 mg SC	10
PF-07209960 30 mg SC	4

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
PF-07209960 1 mg SC	0	Not reported	Not reported	Not reported	Not reported
PF-07209960 3 mg SC	0	Not reported	Not reported	Not reported	Not reported
PF-07209960 10 mg SC	0	Not reported	Not reported	Not reported	Not reported
PF-07209960 15 mg SC	0	Not reported	Not reported	Not reported	Not reported
PF-07209960 20 mg SC	3	Not reported	Not reported	Not reported	Not reported
PF-07209960 30 mg SC	3	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
group Id
OG003
value
0
group Id
OG004
value
3
group Id
OG005
value
3

denoms

counts
group Id
OG000
value
4
group Id
OG001
value
3
group Id
OG002
value
4
group Id
OG003
value
2
group Id
OG004
value
10
group Id
OG005
value
4
units
Participants

description

groups

description
Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
id
OG000
title
PF-07209960 1 mg SC
description
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
id
OG001
title
PF-07209960 3 mg SC
description
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
id
OG002
title
PF-07209960 10 mg SC
description
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
id
OG003
title
PF-07209960 15 mg SC
description
Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
id
OG004
title
PF-07209960 20 mg SC
description
Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
id
OG005
title
PF-07209960 30 mg SC

param Type

COUNT_OF_PARTICIPANTS

population Description

The DLT analysis set was a subset of the safety analysis set. A participant was classified as DLT-evaluable if he/she experienced a DLT or received 100% of the planned doses and had received all scheduled safety assessments during the DLT window.

reporting Status

POSTED

time Frame

Cycle 1 (28 days)

title

Number of Participants With Dose Limiting Toxicities (DLTs)

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice