PCLX-001 for Lymphoma and Cancer

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byRandeep Sangha

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Pacylex Pharmaceuticals

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new oral medicine called PCLX-001. It focuses on patients with certain advanced cancers and difficult-to-treat B-cell lymphomas. The medicine works by targeting and stopping the growth of cancer cells.

Research Team

Randeep Sangha

Principal Investigator

Cross Cancer Institute

Eligibility Criteria

Adults with certain advanced cancers (like B-cell lymphomas and solid tumors) who've tried at least one other treatment without success are eligible for this trial. They should have a life expectancy of over 12 weeks, be able to perform daily activities with minimal assistance (ECOG status 0-1), and have organs functioning well enough to meet specific medical tests. Pregnant women can't join, and participants must agree to use contraception.

Inclusion Criteria

Ability to understand and willingness to sign a written informed consent

My heart functions well, confirmed by a heart scan.

Women of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test obtained within 7 (±3) days before the start of administration of study drug

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Exclusion Criteria

Previous assignment to treatment during this study

Clinically relevant findings in the ECG such as a second- or third-degree atrioventricular block, prolongation of the QRS complex > 120 ms (except for bundle branch block pattern), or prolongation of the of the QTc interval (Fridericia) over 450 ms unless agreed otherwise between the investigator and the sponsor's medically responsible person

I do not have serious infections or those not responding to treatment.

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Treatment Details

Interventions

PCLX-001 (Other)

Trial OverviewThe trial is testing PCLX-001, an oral drug, in two parts: dose escalation to find the safe amount that can be given, followed by expansion cohorts where more patients receive this determined dose. It's open-label meaning everyone knows what treatment they're getting; it's not randomized or controlled against another treatment.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: PCLX-001 interventionExperimental Treatment1 Intervention

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.