PCLX-001 for Lymphoma and Cancer

Recruiting at 4 trial locations

Overseen By Pacylex Pharmaceuticals, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pacylex Pharmaceuticals

Must not be taking: Steroids, CYP3A4 inhibitors

Disqualifiers: Cardiac disease, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

29 Participants Needed

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of PCLX-001 to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D)

28 days per cycle, multiple cycles

Visits at the end of each cycle for safety review

Dose Expansion

Participants receive PCLX-001 at the RP2D to evaluate preliminary clinical activity

28 days per cycle, multiple cycles

Tumor measurements at initiation and end of every 2nd cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• PCLX-001

Trial Overview The 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

Group I: PCLX-001 intervention 70mg Experimental Treatment 1 Intervention

Cohort 3: Participants were administered 70mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle.

Group II: PCLX-001 intervention 40mg Experimental Treatment 1 Intervention

Cohort 2: Participants were administered 40mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle.

Group III: PCLX-001 intervention 280mg Experimental Treatment 1 Intervention

Cohort 7: Participants were administered 280mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle.

Group IV: PCLX-001 intervention 210mg Experimental Treatment 1 Intervention

Cohort 6: Participants were administered 210mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle.

Group V: PCLX-001 intervention 20mg Experimental Treatment 1 Intervention

Cohort 1: Participants were administered 20mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle.

Group VI: PCLX-001 intervention 140mg Experimental Treatment 1 Intervention

Cohort 5: Participants were administered 140mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle.

Group VII: PCLX-001 intervention 100mg Experimental Treatment 1 Intervention

Cohort 4: Participants were administered 100mg of PCLX-001 orally as continuous daily dosing on a 28-day cycle.

Who Is Running the Clinical Trial?

Pacylex Pharmaceuticals

Lead Sponsor

Trials

2

Recruited

100+

Ozmosis Research Inc.

Industry Sponsor

Trials

25

Recruited

5,200+