NCT04836195

Study of PCLX-001 in R/R Advanced Solid Malignancies and B-cell Lymphoma

Phase I Trial of PCLX-001 in Relapsed/Refractory B-cell Non-Hodgkin Lymphoma and Advanced Solid Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Pacylex Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I dose-escalation study of oral PCLX-001, conducted in a multicenter, non-randomized, open-label, non-controlled design. The study is comprised of two parts: Part A (single-agent dose escalation) and Part B (single-agent expansion cohorts).

Detailed description

This is a phase I dose-escalation study of oral PCLX-001, conducted in a multicenter, non-randomized, open-label, non-controlled design. The study is comprised of two parts: Part A (single-agent dose escalation) and Part B (single-agent expansion cohorts). For Part A dose-escalation, patients will be enrolled in cohorts of 3 to 6 patients to each dose level. A new dose level cannot open to accrual until toxicity has been determined in the preceding dose level (i.e. all patients have completed their first cycle of therapy and data for all patients in that dose level have been reviewed at a safety cohort review meeting). Six patients will be treated at the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D). If required, the MTD cohort may be expanded by an additional 10 patients for further toxicity and response assessment. The MTD cohort expansion may be restricted to B-cell lymphoma or advanced solid tumours to ensure there is proper distribution during dose escalation. For Part B (single agent expansion cohorts), two expansion cohorts (N=20 each) will be opened to determine the preliminary clinical activity of PCLX-001 at the RP2D: * Expansion Cohort A: Participants with advanced solid malignancies showing preclinical sensitivity or molecular markers of sensitivity to PCLX-001. This includes breast, nonsmall cell lung (NSCLC), small-cell lung (SCLC), colorectal (CRC), and bladder cancers * Expansion Cohort B: Participants with relapsed/refractory (R/R) B-cell lymphoma: diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and Burkitt lymphoma. Transformed large B-cell lymphoma will also be included.

Conditions

• B-cell Non Hodgkin Lymphoma
• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	PCLX-001 - 20mg	20mg daily oral pills
DRUG	PCLX-001 - 40mg	40mg daily oral pills
DRUG	PCLX-001 - 70mg	70mg daily oral pills
DRUG	PCLX-001 - 100mg	100mg daily oral pills
DRUG	PCLX-001 - 140mg	140mg daily oral pills
DRUG	PCLX-001 - 210mg	210mg daily oral pills
DRUG	PCLX-001 - 280mg	280mg daily oral pills

Timeline

• Start date: 2021-09-14
• Primary completion: 2024-10-28
• Completion: 2024-10-28
• First posted: 2021-04-08
• Last updated: 2025-04-17
• Results posted: 2025-04-17

Locations

4 sites across 1 country: Canada