Phase 1 Myeloma Trial, Recruiting NCT04771572 Sponsor: Newave Pharmaceutical Inc Condition: Myeloma
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Phase 1 Myeloma Trial, Recruiting

NCT04771572
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older (or teenagers aged 13–17 who weigh at least 40 kg, for certain types of acute lymphoblastic leukemia)
  • People who have been diagnosed with certain advanced blood cancers that have come back or stopped responding to treatment, including: chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL); certain bone marrow disorders such as myelofibrosis (MF), myelodysplastic syndromes (MDS), or related conditions; certain types of non-Hodgkin lymphoma (NHL); multiple myeloma; or acute lymphoblastic leukemia (ALL) — specific requirements vary by cancer type and group, so confirm details with the trial site
  • People with certain blood cancers who have already tried at least one or two prior treatments (the exact number required depends on the cancer type — confirm with the trial site)
  • People whose heart is functioning adequately, as measured by a specific heart ultrasound test (confirm with trial site)
  • People whose blood, kidney, and liver test results meet the required levels at the time of screening (confirm with trial site)
  • People who are able to use at least one reliable form of contraception throughout the study and for 90 days after finishing the study drug — this applies to women who could become pregnant and to men who have not had a sterilisation procedure
  • Women who could become pregnant must have a negative pregnancy test before starting the study drug
  • Male participants must avoid donating sperm from the start of the study until 90 days after the last dose
  • People who are able to understand the study information and sign a consent form before any study procedures begin

Who may not be able to join:

  • People who have had a stem cell transplant within the past 60 days, are currently taking immune-suppressing medicines after a transplant, or are experiencing significant graft-versus-host disease
  • People who have had another active cancer in the past 12 months that could interfere with the study, with some exceptions (such as stable breast or prostate cancer on hormone therapy, certain treated skin cancers, or cancers treated with the intent to cure — discuss with the trial site)
  • People who have received cancer treatments, experimental therapies, or live vaccines within 14 days (or within 5 half-lives of the treatment, whichever is shorter) before the first dose, or who have not sufficiently recovered from side effects of previous treatment
  • People who have taken certain medications that affect how the body processes drugs (specific enzyme inhibitors or inducers), or who have consumed grapefruit, Seville oranges, or star fruit within 7 days before starting the study drug
  • People who have previously received CAR-T cell therapy may need to wait at least 28 days before joining (confirm with trial site)
  • People with serious ongoing medical conditions affecting the kidneys, nervous system, lungs, heart, liver, or immune system that, in the investigator's opinion, could affect their safety or the study results
  • People with certain heart rhythm abnormalities, including a prolonged QT interval on a heart tracing, heart failure classified as moderate or severe, a heart attack, stroke, or bleeding in the brain within the past 6 months
  • People with a personal history of a specific inherited heart condition (long QT syndrome) or a serious irregular heartbeat called Torsades de Pointes
  • People with an uncontrolled active infection (bacterial, fungal, or viral), poorly controlled HIV, or active hepatitis B or C infection
  • People who have an unexplained fever above 38.5°C within 7 days before starting the study drug (unless the fever is believed to be caused by the cancer itself — confirm with trial site)
  • Women who are pregnant or breastfeeding
  • People who are unable to swallow tablets or capsules, or who have conditions affecting how the body absorbs medicines taken by mouth
  • People who have active cancer involvement in the brain or spinal cord at the time of screening
  • People who have a known allergy to any ingredient in the study drug LP-118
  • People currently taking certain medications known to cause a serious heart rhythm problem called Torsades de Pointes (a list of these medications would be reviewed by the trial site)
  • People who have had major surgery within 14 days before the first dose of the study drug

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: (206) 335-3820

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Newave Pharmaceutical Inc
Registry
ClinicalTrials.gov
Start date
8 May 2022
Est. completion
31 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Maximum Tolerated Dose (MTD); Recommended Phase 2 Dose (RP2D) or Optimal Biological Dose (OBD); Pharmacokinetic (PK) profile of LP-118: Maximum Plasma Concentration (Cmax); Pharmacokinetic (PK) profile of LP-118: Area Under the Curve (AUC) of LP-118; Pharmacokinetic (PK) profile of LP-118: Time at Maximum Concentration (Tmax) of LP-118

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov