Trial Outcomes & Findings for Study of PCLX-001 in R/R Advanced Solid Malignancies and B-cell Lymphoma (NCT NCT04836195)
NCT ID: NCT04836195
Last Updated: 2025-04-17
Results Overview
The recommended dose will be the dose level below that for the cohort in which maximum tolerated dose (MTD) was reached/exceeded. MTD will have been reached when 2 or more patients in a cohort experience DLT.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
29 participants
Primary outcome timeframe
Through study completion, an average of ~90 days
Results posted on
2025-04-17
Participant Flow
Participant milestones
| Measure |
PCLX-001 Intervention 20mg
20mg daily oral pills for 28 days
|
PCLX-001 Intervention 40mg
Drug: PCLX-001 - 40mg
40mg daily oral pills for 28 days
|
PCLX-001 - 70mg
70mg daily oral pills for 28 days
|
PCLX-001 Intervention 100mg
100mg daily oral pills for 28 days
|
PCLX-001 Intervention 140mg
140mg daily oral pills for 28 days
|
PCLX-001 Intervention 210mg
210mg daily oral pills for 28 days
|
PCLX-001 Intervention 280mg
280mg daily oral pills for 28 days
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
6
|
3
|
8
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
8
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of PCLX-001 in R/R Advanced Solid Malignancies and B-cell Lymphoma
Baseline characteristics by cohort
| Measure |
PCLX-001 Intervention 20mg
n=3 Participants
Cohort 1: Participants were administered 20mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle.
|
PCLX-001 Intervention 40mg
n=3 Participants
Cohort 2: Participants were administered 40mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle.
|
PCLX-001 Intervention 70mg
n=3 Participants
Cohort 3: Participants were administered 70mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle.
|
PCLX-001 Intervention 100mg
n=6 Participants
Cohort 4: Participants were administered 100mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle.
|
PCLX-001 Intervention 140mg
n=3 Participants
Cohort 5: Participants were administered 140mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle.
|
PCLX-001 Intervention 210mg
n=8 Participants
Cohort 6: Participants were administered 210mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle.
|
PCLX-001 Intervention 280mg
n=3 Participants
Cohort 7: Participants were administered 280mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
68 years
n=7 Participants
|
66 years
n=5 Participants
|
53 years
n=4 Participants
|
65 years
n=21 Participants
|
56 years
n=8 Participants
|
48 years
n=8 Participants
|
65 years
n=24 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
18 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
27 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
Canada
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
29 Participants
n=24 Participants
|
|
Patients enrolled
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
3 participants
n=21 Participants
|
8 participants
n=8 Participants
|
3 participants
n=8 Participants
|
29 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of ~90 daysPopulation: Refractory solid tumour and Non-Hodgkins Lymphoma patients for whom no other therapies were available. All evaluable patients were assessed.
The recommended dose will be the dose level below that for the cohort in which maximum tolerated dose (MTD) was reached/exceeded. MTD will have been reached when 2 or more patients in a cohort experience DLT.
Outcome measures
| Measure |
PCLX-001 Intervention
n=29 Participants
The Dose-Escalation phase will follow a standard 3+3 cohort design. Three patients will be treated at each dose level. If 0/3 patients experience DLT, 3 patients will be treated at the next dose level. Escalation will terminate as soon as two or more patients experience any DLT attributable to study drugs, at a given dose level.
Oral PCLX-001 will be provided as continuous daily dosing on a 28-day cycle.
PCLX-001: To ensure maximal safety in this first-in-human trial, the starting dose level was chosen to be 20 mg daily on a 28-day cycle.
|
|---|---|
|
To Determine, During the Dose Escalation Phase, the Recommended Dose of PCLX-001 for the Dose Expansion Phase of the Trial.
|
210 mg
|
Adverse Events
PCLX-001 Intervention 20mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PCLX-001 Intervention 40mg
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
PCLX-001 Intervention 70mg
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
PCLX-001 Intervention 100mg
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
PCLX-001 Intervention 140mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PCLX-001 Intervention 210mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PCLX-001 Intervention 280mg
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PCLX-001 Intervention 20mg
n=3 participants at risk
Cohort 1: Participants were administered 20mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle.
|
PCLX-001 Intervention 40mg
n=3 participants at risk
Cohort 2: Participants were administered 40mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle.
|
PCLX-001 Intervention 70mg
n=3 participants at risk
Cohort 3: Participants were administered 70mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle.
|
PCLX-001 Intervention 100mg
n=6 participants at risk
Cohort 4: Participants were administered 100mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle.
|
PCLX-001 Intervention 140mg
n=3 participants at risk
Cohort 5: Participants were administered 140mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle.
|
PCLX-001 Intervention 210mg
n=8 participants at risk
Cohort 6: Participants were administered 210mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle.
|
PCLX-001 Intervention 280mg
n=3 participants at risk
Cohort 7: Participants were administered 280mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/6 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/8 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/6 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/8 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/6 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/8 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/6 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/8 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
|
General disorders
Fever
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/6 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/8 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
|
Immune system disorders
COVID 19
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
16.7%
1/6 • Number of events 1 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/8 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/6 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/8 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
33.3%
1/3 • Number of events 1 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/6 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/8 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
|
Hepatobiliary disorders
Hepatobiliary Disorder
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/6 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/3 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
0.00%
0/8 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
66.7%
2/3 • Number of events 2 • Through study completion, an average of ~90 days
SAE defined as Grade 3 or higher treatment emergent adverse event.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place