Trial · NCT04836195
Study of PCLX-001 in R/R Advanced Solid Malignancies and B-cell Lymphoma
NCT04836195, Phase 1, Completed, Pacylex Pharmaceuticals; results first posted 2025-04-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of PCLX-001 in R/R Advanced Solid Malignancies and B-cell Lymphoma. Trials, record NCT04836195. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04836195
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of PCLX-001 in R/R Advanced Solid Malignancies and B-cell Lymphoma
- NCT number
- NCT04836195
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 29 participants, actual
- Lead sponsor
- Pacylex Pharmaceuticals
- Conditions
- B-cell Non Hodgkin Lymphoma, Advanced Solid Tumor
- Interventions
- PCLX-001 - 20mg, PCLX-001 - 40mg, PCLX-001 - 70mg, PCLX-001 - 100mg, PCLX-001 - 140mg, PCLX-001 - 210mg, PCLX-001 - 280mg
- First posted
- 2021-04-08
- Last updated
- 2025-04-17
- Results first posted
- 2025-04-17
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To Determine, During the Dose Escalation Phase, the Recommended Dose of PCLX-001 for the Dose Expansion Phase of the Trial. | Through study completion, an average of ~90 days | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | To Determine, During the Dose Escalation Phase, the Recommended Dose of PCLX-001 for the Dose Expansion Phase of the Trial. | Through study completion, an average of ~90 days | Refractory solid tumour and Non-Hodgkins Lymphoma patients for whom no other therapies were available. All evaluable patients were assessed. | mg | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| To Determine, During the Dose Escalation Phase, the Recommended Dose of PCLX-001 for the Dose Expansion Phase of the Trial. | PCLX-001 Intervention | 210 | mg |
Source ClinicalTrials.gov
Participant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PCLX-001 Intervention 20mg | 3 | |
| Overall Study | STARTED | PCLX-001 Intervention 40mg | 3 | |
| Overall Study | STARTED | PCLX-001 - 70mg | 3 | |
| Overall Study | STARTED | PCLX-001 Intervention 100mg | 6 | |
| Overall Study | STARTED | PCLX-001 Intervention 140mg | 3 | |
| Overall Study | STARTED | PCLX-001 Intervention 210mg | 8 | |
| Overall Study | STARTED | PCLX-001 Intervention 280mg | 3 | |
| Overall Study | COMPLETED | PCLX-001 Intervention 20mg | 3 | |
| Overall Study | COMPLETED | PCLX-001 Intervention 40mg | 3 | |
| Overall Study | COMPLETED | PCLX-001 - 70mg | 3 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events63
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Diarrhea | Gastrointestinal disorders | PCLX-001 Intervention 20mg | 0 | 3 | 0 |
| serious | Diarrhea | Gastrointestinal disorders | PCLX-001 Intervention 40mg | 0 | 3 | 0 |
| serious | Diarrhea | Gastrointestinal disorders | PCLX-001 Intervention 70mg | 0 | 3 | 0 |
| serious | Diarrhea | Gastrointestinal disorders | PCLX-001 Intervention 100mg | 0 | 6 | 0 |
| serious | Diarrhea | Gastrointestinal disorders | PCLX-001 Intervention 140mg | 0 | 3 | 0 |
| serious | Diarrhea | Gastrointestinal disorders | PCLX-001 Intervention 210mg | 0 | 8 | 0 |
| serious | Diarrhea | Gastrointestinal disorders | PCLX-001 Intervention 280mg | 1 | 3 | 1 |
| serious | Dehydration | Gastrointestinal disorders | PCLX-001 Intervention 20mg | 0 | 3 | 0 |
| serious | Dehydration | Gastrointestinal disorders | PCLX-001 Intervention 40mg | 0 | 3 | 0 |
| serious | Dehydration | Gastrointestinal disorders | PCLX-001 Intervention 70mg | 0 | 3 | 0 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PCLX-001 Intervention 20mg | 0 | 3 |
| Total, all-cause mortality | PCLX-001 Intervention 40mg | 1 | 3 |
| Total, all-cause mortality | PCLX-001 Intervention 70mg | 1 | 3 |
| Total, all-cause mortality | PCLX-001 Intervention 100mg | 1 | 6 |
| Total, all-cause mortality | PCLX-001 Intervention 140mg | 0 | 3 |
| Total, all-cause mortality | PCLX-001 Intervention 210mg | 0 | 8 |
| Total, all-cause mortality | PCLX-001 Intervention 280mg | 0 | 3 |
| Total, other adverse events | PCLX-001 Intervention 20mg | 0 | 3 |
| Total, other adverse events | PCLX-001 Intervention 40mg | 0 | 3 |
| Total, other adverse events | PCLX-001 Intervention 70mg | 0 | 3 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04836195
GET https://conductscience.org/api/trials/v1/NCT04836195/flow?page=2