CLL/SLLPhase 1NCT04775745

Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies.

A Phase 1 study testing LP-168 in people with CLL/SLL and Waldenstrom Macroglobulinemia, run by Newave Pharmaceutical Inc at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This is a phase I, multi-center, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and clinical activity of LP-168 in subjects with relapsed or refractory B-cell malignancies. LP-168 is a small molecule inhibitor. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: CLL/SLL, Waldenstrom Macroglobulinemia, Follicular Lymphoma
What is being tested?: LP-168
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 4 sitesUnited States
Study dates: 19 Jul 2021to 31 Dec 2027
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

A subject will be eligible for study participation if he/she meets the following criteria:
Subjects are eligible with B-cell malignancies, WM, FL, MCL, MZL, DLBCL, HCL, CLL, SLL, based upon 2016 updated WHO classification. Those subjects with WM, FL, MCL, DLBCL, or HCL must have received at least 2 prior systemic therapies.
Low-grade B-cell lymphomas as follicular Grade 1, 2, or 3A, marginal zone or small lymphocytic lymphoma.
Subject must have adequate coagulation, renal, and hepatic function, per local laboratory reference ranges at Screening as follows:
Activated partial thromboplastin time (APTT) and prothrombin time (PT) not to exceed 1.5 × ULN
Calculated creatinine clearance (CrCl) ≥ 60 mL/min using 24-hour CrCl OR Cockcroft-Gault formula.

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Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 ×ULN; Bilirubin ≤ 1.5 × ULN (except subjects with Gilbert's Syndrome, who may have a bilirubin > 1.5 × ULN, per discussion between the Investigator and the Medical Monitor).
Subjects must have adequate bone marrow independent of growth factor support per local laboratory reference range at screening as follows:
Absolute Neutrophil Count (ANC) ≥1000/uL;
An exception is for subjects with an ANC<1000/uL and bone marrow heavily infiltrated with underlying disease (approximately 60% or more) may use growth factor to achieve the ANC eligibility criteria per discussion between the Investigator and the Medical Monitor.
Platelet count ≥ 50,000/µL - OR - Platelet count ≥ 20,000/ µL if thrombocytopenia is clearly due to CLL disease under study (per Investigator discretion)
Hemoglobin ≥8.0g/dL, and can be achieved by transfusion

Who cannot join

A subject will not be eligible for study participation if he/she meets any of the following criteria.
Subject has received any of the following therapies within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug, or has not recovered to ≤ Grade 1 clinically significant adverse effect(s)/toxicity(s) of the previous therapy (other than alopecia):
Any anti-cancer therapy including chemotherapy, biologic or immunotherapy, radiotherapy, etc;
Any investigational therapy, including targeted small molecule agents.
For CLL subjects who come off BCR antagonists (BTK inhibitors, PI3K inhibitors, etc.) treatment, allow 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).
Subjects who require immediate cytoreduction. However, subjects may receive up to two days of steroids for symptoms of impending organ impairment and remain eligible.

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Subject has received the following medications or therapies within 7 days prior to the first dose of study drug:
Steroid therapy (at dosages equivalent to prednisone >20 mg/day) for anti-neoplastic intent (except as noted in exclusion criteria #3);
Cytochrome P450, family 3, subfamily A (CYP3A4) strong inhibitors and strong CYP2C8 inducers/inhibitors.
Potent CYP3A4 inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort.
Subjects require treatment with systemic acid-reducing agents including H-2-receptor antagonists and proton pump inhibitors with the following exceptions:
Proton pump inhibitors should be discontinued at least 7 days prior and held throughout the study
If concurrent use of an H2 blocking agent is necessary, it must be administered only between 2 and 3 hours after the dose of LP-168. If not taken during this time, the dose of H2 blocking agents should not be taken again until 2-3 hours after the next dose of LP-168.
If concurrent use of a local antacid is necessary, it must be administered 2 or more hours before and/or 2 or more hours after the dose of LP-168.
Subject has significant screening electrocardiogram (ECG) abnormalities including. 2nd degree AV block type II 3rd degree block, Grade 2 or higher bradycardia, and corrected QT interval (QTc) ≥ 480ms.
Serum amylase > 1.5 × ULN or serum lipase > 1.5 × ULN.
Subject has any history of Richter's transformation for Phase 1a portion of the trial.
Subjects who have undergone autologous/allogeneic hematopoietic stem cell transplantation (HSCT) therapy within 90 days of the first dose of LP-168, or patients on immunosuppressive therapy post-HSCT at the time of Screening, or currently with clinically significant graft-versus-host disease (GVHD) as per treating physician (Patients 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 active malignancies other than B-cell malignancies within the past 3 years prior to study entry, with the exception of:
Adequately treated in situ carcinoma of the cervix uteri;
Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
Subject requires anticoagulation with Warfarin.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Anna Chen, MD, PhD contact

(206) 335-3820

yu@newavepharma.com

Stephen Anthony, DO contact

s.anthony@newavepharma.com

United States4 sites, 4 recruiting

University of Cincinnati
Cincinnati, Ohio, 45221
Recruiting
Ohio State University
Columbus, Ohio, 43210
Recruiting
Duke Univerisity
Durham, North Carolina, 27708
Recruiting
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
Recruiting

Other trials in United States

About this study

Official title: A Phase I, Multicenter, Open-Label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-168 in Subjects With Relapsed or Refractory B-cell Malignancies.

Read the detailed description

The primary objectives for the study are to assess the safety and tolerability profile, determine the maximum tolerated dose (MTD), and/or the recommended Phase 2 dose (RP2D) of LP-168 administered once or twice daily as a single agent dosed orally in adult subjects with relapsed/refractory B-cell Malignancies (CLL/SLL, WM, FL, MCL, MZL, DLBCL, HCL); and to characterize the pharmacokinetics (PK) profile of LP-168 in adult subjects with relapsed/refractory B-cell Malignancies (CLL/SLL, WM, FL, MCL, MZL, DLBCL, HCL).

Secondary objectives of the study are to evaluate preliminary efficacy regarding the effect of LP-168 on progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR) in adult subjects with relapsed/refractory B-cell Malignancies (CLL/SLL, WM, FL, MCL, MZL, DLBCL, HCL).

Once the MTD is declared and the RP2D is established, additional subjects will be enrolled in a cohort expansion phase (Phase 1b).

Conditions: CLL/SLL, Waldenstrom Macroglobulinemia, Follicular Lymphoma, Diffuse Large B Cell Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma
Being tested: LP-168
Medical subject headings: Waldenstrom Macroglobulinemia, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone, Leukemia, Hairy Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LP-168Drug
For the dose escalation phase, LP-168 will be given once or twice daily at the following dose levels:100 mg QD,150 mg QD, 100 mg BID, 300 mg QD, 150 mg BID, 450 mg QD, 225 mg BID, 600 mg QD, 800 mg QD, and 1000 mg QD.
LP-168Drug
For the dose expansion phase, subjects will receive once or twice daily dose of LP-168 at the Recommended Phase 2 Dose (RP2D). The RP2D may be as high as the MTD and will be determined following evaluation of Phase I Dose Escalation results.

Study groups in NCT04775745
Study group	Role	What they receive
Dose Escalation Phase	Experimental	Three to six subjects per treatment cohort will be assigned to receive sequentially higher oral doses of LP-168 on a once or twice daily schedule for 28 days, starting at a dose of 100 mg/day. Receives: Drug: LP-168
Dose Expansion Phase	Experimental	Additional subjects will be recruited to further explore the safety, tolerability, PK, and efficacy in specific subject subgroups. Receives: Drug: LP-168

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Tolerated Dose (MTD)
When more than 1 DLT occurs in ≤ 6 subjects in a dosing cohort, dose escalation will be stopped and this dose level will be identified as the non-tolerated dose. Doses between the non-tolerated dose and the preceding lower dose, where ≤ 1 DLT occurred, may be explored to more precisely define the MTD.
Measured: Up to 24 months, each cycle is 28 days
Recommended Phase 2 dose (RP2D)
The RP2D 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 data, and PK data.
Measured: Up to 24 months, each cycle is 28 days
Pharmacokinetic (PK) profile of LP-168
Maximum Plasma Concentration [Cmax]
Measured: At Cycle 1: Day 1, Day 2, Day 8, Day 9, Day 15, Day 22, Day 28; At Cycle 3: Day 28; At Cycle 6 Day 28; (each cycle is 28 days)
Pharmacokinetic (PK) profile of LP-168
Area Under the Curve [AUC]
Measured: At Cycle 1: Day 1, Day 2, Day 8, Day 9, Day 15, Day 22, Day 28; At Cycle 3: Day 28; At Cycle 6 Day 28; (each cycle is 28 days
Pharmacokinetic (PK) profile of LP-168
Time at Maximum Concentration [Tmax]
Measured: At Cycle 1: Day 1, Day 2, Day 8, Day 9, Day 15, Day 22, Day 28; At Cycle 3: Day 28; At Cycle 6 Day 28; (each cycle is 28 days

Secondary outcomes (3)

Progression-Free Survival (PFS)
PFS is measured from the time of first study drug administration until the first date that recurrent or progressive disease is objectively documented.
Measured: Up to 24 months, each cycle is 28 days
Objective Response Rate (ORR)
ORR is defined as the sum of complete response (CR) and partial remission rates.
Measured: Up to 24 months, each cycle is 28 days
Duration of Response (DOR)
The duration of overall response is measured from the time measurement criteria are met for CR or PR (which is first recorded) until the first date that recurrent or progressive disease is objectively documented
Measured: Up to 24 months, each cycle is 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jul 202131 Dec 2027

First posted1 Mar 2021
Study start19 Jul 2021
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for CLL/SLLStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: A classic "3+3" design will be used to establish the dose-limiting toxicity (DLT), MTD, and RP2D. Three to six subjects per treatment cohort will be assigned to receive sequentially higher oral doses of LP-168 on a once or twice daily schedule for 28 days (a "Cycle"), starting at a dose of 100 mg/day. Once all subjects in a given cohort have reached Cycle 1 Day 28, these data will be reviewed by the Safety Review Committee (SRC) for decisions on dose escalation for a new dose cohort. Subjects will receive once-daily or twice-daily oral dose of LP-168 until disease progression, unacceptable toxicity, or a clinical observation satisfying another criterion for withdrawal from treatment is noted.
Masking: None (open label)
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04775745
Sponsor's protocol ID: LP-168-US-I01
Status last verified: Feb 2026
First submitted: 22 Feb 2021
Last updated: 13 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Multicenter, Open-Label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-168 in Subjects With Relapsed or Refractory B-cell Malignancies.
ClinicalTrials.gov ID: NCT04775745
Acronym / sponsor ID: LP-168-US-I01
Conditions: CLL/SLL, Waldenstrom Macroglobulinemia, Follicular Lymphoma, Diffuse Large B Cell Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 60 participants (estimated)
Lead sponsor: Newave Pharmaceutical IncIndustry (pharma, biotech, devices)
Study start: 19 Jul 2021 (actual)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 1 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Once the MTD is declared and the RP2D is established, additional subjects will be enrolled in a cohort expansion phase (Phase 1b).

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: A classic "3+3" design will be used to establish the dose-limiting toxicity (DLT), MTD, and RP2D. Three to six subjects per treatment cohort will be assigned to receive sequentially higher oral doses of LP-168 on a once or twice daily schedule for 28 days (a "Cycle"), starting at a dose of 100 mg/day. Once all subjects in a given cohort have reached Cycle 1 Day 28, these data will be reviewed by the Safety Review Committee (SRC) for decisions on dose escalation for a new dose cohort. Subjects will receive once-daily or twice-daily oral dose of LP-168 until disease progression, unacceptable toxicity, or a clinical observation satisfying another criterion for withdrawal from treatment is noted.

Arm	Type	Receives
Dose Escalation Phase	Experimental	Drug: LP-168Three to six subjects per treatment cohort will be assigned to receive sequentially higher oral doses of LP-168 on a once or twice daily schedule for 28 days, starting at a dose of 100 mg/day.
Dose Expansion Phase	Experimental	Drug: LP-168Additional subjects will be recruited to further explore the safety, tolerability, PK, and efficacy in specific subject subgroups.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

A subject will be eligible for study participation if he/she meets the following criteria:
Subjects are eligible with B-cell malignancies, WM, FL, MCL, MZL, DLBCL, HCL, CLL, SLL, based upon 2016 updated WHO classification. Those subjects with WM, FL, MCL, DLBCL, or HCL must have received at least 2 prior systemic therapies.
Low-grade B-cell lymphomas as follicular Grade 1, 2, or 3A, marginal zone or small lymphocytic lymphoma.
Subject must have adequate coagulation, renal, and hepatic function, per local laboratory reference ranges at Screening as follows:
Subjects must have adequate bone marrow independent of growth factor support per local laboratory reference range at screening as follows:

Key exclusion criteria (23 listed)

A subject will not be eligible for study participation if he/she meets any of the following criteria.
Subject has received any of the following therapies within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug, or has not recovered to ≤ Grade 1 clinically significant adverse effect(s)/toxicity(s) of the previous therapy (other than alopecia):
Subjects who require immediate cytoreduction. However, subjects may receive up to two days of steroids for symptoms of impending organ impairment and remain eligible.
Subject has received the following medications or therapies within 7 days prior to the first dose of study drug:
Subjects require treatment with systemic acid-reducing agents including H-2-receptor antagonists and proton pump inhibitors with the following exceptions:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LP-168For the dose escalation phase, LP-168 will be given once or twice daily at the following dose levels:100 mg QD,150 mg QD, 100 mg BID, 300 mg QD, 150 mg BID, 450 mg QD, 225 mg BID, 600 mg QD, 800 mg QD, and 1000 mg QD.	Drug	Dose Escalation Phase
LP-168For the dose expansion phase, subjects will receive once or twice daily dose of LP-168 at the Recommended Phase 2 Dose (RP2D). The RP2D may be as high as the MTD and will be determined following evaluation of Phase I Dose Escalation results.	Drug	Dose Expansion Phase

Primary outcome

Maximum Tolerated Dose (MTD)
Time frame: Up to 24 months, each cycle is 28 days
When more than 1 DLT occurs in ≤ 6 subjects in a dosing cohort, dose escalation will be stopped and this dose level will be identified as the non-tolerated dose. Doses between the non-tolerated dose and the preceding lower dose, where ≤ 1 DLT occurred, may be explored to more precisely define the MTD.
Recommended Phase 2 dose (RP2D)
Time frame: Up to 24 months, each cycle is 28 days
The RP2D 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 data, and PK data.
Pharmacokinetic (PK) profile of LP-168
Time frame: At Cycle 1: Day 1, Day 2, Day 8, Day 9, Day 15, Day 22, Day 28; At Cycle 3: Day 28; At Cycle 6 Day 28; (each cycle is 28 days)
Maximum Plasma Concentration [Cmax]
Pharmacokinetic (PK) profile of LP-168
Time frame: At Cycle 1: Day 1, Day 2, Day 8, Day 9, Day 15, Day 22, Day 28; At Cycle 3: Day 28; At Cycle 6 Day 28; (each cycle is 28 days
Area Under the Curve [AUC]
Pharmacokinetic (PK) profile of LP-168
Time frame: At Cycle 1: Day 1, Day 2, Day 8, Day 9, Day 15, Day 22, Day 28; At Cycle 3: Day 28; At Cycle 6 Day 28; (each cycle is 28 days
Time at Maximum Concentration [Tmax]

3 secondary outcomes

Progression-Free Survival (PFS)
Time frame: Up to 24 months, each cycle is 28 days
Objective Response Rate (ORR)
Time frame: Up to 24 months, each cycle is 28 days
Duration of Response (DOR)
Time frame: Up to 24 months, each cycle is 28 days

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Anna Chen, MD, PhD contact

(206) 335-3820

yu@newavepharma.com

Stephen Anthony, DO contact

s.anthony@newavepharma.com

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LP-168 in people with CLL/SLL and Waldenstrom Macroglobulinemia, run by Newave Pharmaceutical Inc at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anna Chen, MD, PhD ((206) 335-3820, yu@newavepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) (time frame: Up to 24 months, each cycle is 28 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04775745.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.