LP-118 for Leukemia

Recruiting at 7 trial locations

Overseen By Anna Chen, MD, PhD

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Newave Pharmaceutical Inc

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

Disqualifiers: Recent HSCT, Active malignancies, others

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

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

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.

Are You a Good Fit for This Trial?

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.

My CLL/SLL is low risk, progressed on BTK inhibitors, and I've had at least 2 prior treatments.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• LP-118

Trial Overview LP-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).

How Is the Trial Designed?

Group I: Dose Expansion Phase Experimental Treatment 1 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 Phase Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Newave Pharmaceutical Inc

Lead Sponsor

Trials

4

Recruited

270+