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Study of Oral Administration of LP-118 in Patients With Relapsed or Refractory CLL, SLL, MDS, MDS/MPN, AML, CMML-2, MPN-BP, ALL, MF, NHL, RT, MM or T-PLL.

ConditionsNon Hodgkin LymphomaRichter TransformationMultiple MyelomaT-cell-prolymphocytic LeukemiaAcute Myeloid LeukemiaAcute Lymphocytic LeukemiaMyeodysplastic SyndromeMyelodysplastic/Myeloproliferative NeoplasmMyelofibrosisChronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaChronic Myelomonocytic Leukemia-2Myelodysplastic Neoplasm in Blast Phase
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age13+
SponsorNewave Pharmaceutical Inc

About this trial

This is a Phase 1, multi-center, open-label study with a dose-escalation phase (Phase 1a) and a cohort expansion phase (Phase 1b), to evaluate the safety, tolerability, and PK profile of LP-118 under a once daily oral dosing schedule in up to 100 subjects.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Relapsed or refractory low risk tumor lysis CLL/SLL subjects (ALC < 25 x 109 cells/L and all lymph nodes < 5 cm) who have received at least two prior therapies. Subjects may also have slowly progressed on irreversible BTK inhibitors while on treatment with these agents.

For CLL/SLL subjects who come off BCR antagonist treatment (BTK inhibitors, P13K inhibitors, etc.) allows washout for 2 days as these subjects, progress quickly after treatment discontinuation and then remain eligible (steroids may be given during these two days to allow disease control).

Morphologically confirmed diagnosis of MF in accordance with the WHO 2016 revised criteria, that is relapsed, intolerant, and/or refractory and that, in the opinion of the Investigator, subjects who have no available therapies known to provide clinical benefits;

Morphologically confirmed diagnosis of MDS/MPN, excluding juvenile myelomonocytic leukemia (JMML), in accordance with WHO 2016 revised criteria, that is relapsed and/or refractory and that, in the opinion of the Investigator, subjects who have no available therapies known to provide clinical benefits;

Disqualifiers

Subjects who have undergone autologous/allogeneic hematopoietic stem cell transplantation (HSCT) therapy within 60 days of the first dose of LP-118, or subjects on immunosuppressive therapy post-HSCT at the time of Screening, or currently with clinically significant graft-versus-host disease (GVHD) as per treating physician (Subjects in relapse after allogeneic transplantation must be off treatment with systemic immunosuppressive agents for at least 4 weeks. The use of topical steroids and/or up to 20 mg/day prednisone or equivalent systemic steroids for ongoing GVHD is permitted.

Subject has a history of other malignancies within past 12 months that are active and could result in competing risks. These cases shall be discussed with the Medical Monitor with the exception below.

Subject with breast cancer or prostate cancer on endocrine therapy with stable disease;

Continuation of maintenance therapy in patients with adequately treated malignancy

Trial design

Design model

Sequential

Treatments tested in this trial

  • LP-118

    Drug

    novel, oral, selective treatment for hematological malignancies tested through ascending dose levels

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Dose Escalation PhaseExperimental treatment 1 intervention
Group B: Dose Expansion PhaseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum Tolerated Dose (MTD)

If 2 out of 6 subjects in an expanded cohort experience a DLT then this dose is considered the MTD.

Time frame
At the end of cycle 1 (each cycle is 28 days)
2

Recommended Phase 2 Dose (RP2D) or Optimal Biological Dose (OBD)

The RP2D pr OBD may be as high as the MTD or a lower dose and will be selected in discussion with the Investigators and the Sponsor based on longer term safety data, preliminary efficacy, and PK data. OBD is defined as the lowest dose providing the highest rate of efficacy while being safely administered.

Time frame
At the end of cycle 1 (each cycle is 28 days)
3

Pharmacokinetic (PK) profile of LP-118: Maximum Plasma Concentration (Cmax)

Time frame
At Cycle 0 Day 1, Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1, Cycle 8 Day 1, Cycle 9 Day 1 (28-day cycles))
4

Pharmacokinetic (PK) profile of LP-118: Area Under the Curve (AUC) of LP-118

Time frame
At Cycle 0 Day 1, Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 15, Cycle 1 Day 16, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1, Cycle 8 Day 1, Cycle 9 Day 1 (28-day cycles)

Secondary outcomes

1

Progression-Free Survival (PFS)

The number of days from the date the subject started study drug to the date the subject experiences an event of disease progression (radiographic or clinical), or to the date of death if disease progression is not reached.

Time frame
Approximately 36 cycles (each cycle has 28 days)
2

Duration of Response (DOR)

The number of days from the date the subject started study drug to the date of the subject's death due to any cause.

Time frame
Approximately 36 cycles (each cycle is 28 days)
3

Overall Survival (OS)

The number of days from the date the subject started study drug to the date of the subject's death due to any cause.

Time frame
Approximately 36 cycles (each cycle is 28 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Newave Pharmaceutical Inc

Lead sponsor

Source ClinicalTrials.gov
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