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

NCT04836195 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-04-17

Study results available
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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).

Conditions

  • B-cell Non Hodgkin Lymphoma
  • Advanced Solid Tumor

Interventions

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

Sponsors & Collaborators

  • Pacylex Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Randeep Sangha · Cross Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-14
Primary Completion
2024-10-28
Completion
2024-10-28

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04836195 on ClinicalTrials.gov