LP-118 for Leukemia

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Newave Pharmaceutical Inc

Must not be taking: CYP3A inhibitors, CYP3A inducers, TdP drugs

Disqualifiers: Recent HSCT, Active malignancies, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new oral drug, LP-118, taken regularly in adults with blood cancers that have returned or resisted other treatments. It aims to find the safest and most effective dose and see if it helps control the cancer.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop all current medications, but it does mention a 2-day washout period (time without taking certain medications) for some treatments like BCR antagonists and JAK2 antagonists. Additionally, certain medications, such as strong CYP3A inhibitors and inducers, should be avoided before starting the trial.

Research Team

Eligibility Criteria

Adults with various advanced blood cancers like CLL, SLL, ALL, AML, and others who have tried at least one or two prior treatments without success can join this trial. It's also open to certain adolescents (13-18) with B cell ALL if they weigh over 40 kg. Participants need good heart function and adequate bone marrow, liver, and kidney function.

Inclusion Criteria

My condition is an advanced blood cancer.

Criterion: Participants with certain types of advanced or high-risk leukemia or lymphoma who have received several previous treatments and have specific levels of blood cells, heart function, bone marrow, blood clotting, kidney function, and liver function within normal ranges.

I am 18 or older, or between 13-18 and weigh at least 40 kg if I have T cell or B cell ALL.

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Exclusion Criteria

I haven't taken strong medication affecting liver enzymes or certain cancer treatments in the last 7 days.

Your heart's electrical activity is abnormal, or you have a heart condition that affects your daily activities.

I haven't had a stem cell transplant in the last 60 days and am not on strong immune system drugs.

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Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation Phase

Phase 1a dose-escalation to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) using a 3+3 study design

Approximately 4-8 weeks

Dose Expansion Phase

Additional subjects recruited to further explore safety, tolerability, PK, and efficacy in specific subgroups

Approximately 36 cycles (each cycle is 28 days)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

LP-118 (Other)

Trial OverviewLP-118 is an oral medication being tested in a Phase 1 clinical trial for safety and how the body processes it. The study has two parts: first finding the right dose (Phase 1a), then giving that dose to more people to learn more about its effects (Phase 1b).

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Dose Expansion PhaseExperimental Treatment1 Intervention

Additional subjects will be recruited to further explore the safety, tolerability, PK, and efficacy in specific subject subgroups. One or more RP2D may be explored. Definition of these cohorts will be accomplished by protocol amendment, and in light of emerging data from Phase 1a.

Group II: Dose Escalation PhaseExperimental Treatment1 Intervention

Phase 1a dose-escalation will begin with group 1 and proceed until DLT is observed and MTD is established, or until an RP2D is established. Subjects enrolled in the dose cohorts will follow the 3+3 study design, starting with an accelerated step-up dosing schedule (with a starting dose of 20 mg, 50 mg, 100 mg once daily) until they reach the designated target dose (50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, 800 mg). Once the MTD or RP2D is established for group 1, the phase 1a dose escalation can proceed for group 2. The starting dose level for group 2 will be one dose level below the MTD or RP2D established for group 1.