A Study of PLX2853 in Advanced Malignancies.

Study summary

The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the investigational drug PLX2853 in subjects with advanced malignancies.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPLX2853

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 25, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?5 U.S. locations

Locations may change over time.

Who runs it?Opna Bio LLC

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Opna Bio LLC
Interventions being studied: Drug: PLX2853

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Small cell lung cancer (SCLC)→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Confirmed diagnosis of one of the following:
Phase 1b:
Histologically confirmed advanced refractory solid tumor that is measurable or evaluable per RECIST 1.1 criteria.
Histologically confirmed NHL: diffuse large B-cell lymphoma and follicular lymphoma (Grade 1-3A) which is measurable or evaluable per Lugano criteria, has progressed following at least 1 line of prior anticancer therapy.
Phase 2a: Patients with various solid tumors or NHL who have received prior therapy.
Age ≥18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Adequate organ function as appropriate for the disease under study. All screening laboratory tests should be performed within 10 days of treatment initiation.
Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test at Screening (≤7 days prior to 1st study drug dose) and must agree to use an effective form of contraception from the time of the negative pregnancy test up to 90 days after the last dose of study drug. Effective forms of contraception include abstinence, hormonal contraceptive in conjunction with a barrier method, or a double barrier method. Women of non-child-bearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year.
Fertile men must agree to use an effective method of birth control during the study and for up to 90 days after the last dose of study drug.
All associated clinically significant drug-related toxicity from previous cancer therapy must be resolved prior to study treatment administration (alopecia, erectile impotence, hot flashes, decreased libido, and neuropathy is allowed).
Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements

Reasons someone may not be able to joinExclusion criteria

Prior exposure to a bromodomain inhibitor, such as OTX-015 or CPI-0610
Known uncontrolled fungal, bacterial, and/or viral infection ≥Grade 2
Autoimmune hemolytic anemia or autoimmune thrombocytopenia
Presence of symptomatic or uncontrolled central nervous system or leptomeningeal metastases
Known or suspected allergy to the investigational agent or any agent given in association with this trial
Clinically significant cardiac disease such as cardiac arrhythmias including bradyarrhythmias and/or subjects who require anti-arrhythmic therapy (excluding beta blockers or digoxin), including uncontrolled hypertension or arterial or venous thrombotic events. Subjects with controlled atrial fibrillation are not excluded.
Inability to take oral medication or significant nausea and vomiting, malabsorption, or significant small bowel resection that, in the opinion of the Investigator, would preclude adequate absorption
Non-healing wound, ulcer, or bone fracture
Subject has known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection or is known to be a carrier of hepatitis B or C. Subjects who are positive for hepatitis C virus (HCV) antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible. Subjects with occult or prior hepatitis B virus (HBV) infection (defined as positive total hepatitis B core antibody (HBcAb) and negative hepatitis B surface antigen (HBsAg) may be included if HBV DNA is undetectable. These subjects must be willing to undergo additional testing per local standard of care.
Active second malignancy with the exception of any of the following:
Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer;
Adequately treated Stage I cancer from which the subject is currently in remission and has been in remission for ≥2 years;
Low-risk prostate cancer with Gleason score \<7 and prostate-specific antigen \<10 ng/mL; or
Any other cancer from which the patient has been disease-free for ≥3 years.
Subjects with documented hepatic metastases involving \>50% of the hepatic parenchyma, or any individual liver metastasis \>5 cm, as assessed by the investigator.
Major surgery or significant traumatic injury within 14 days prior to Cycle 1 Day 1
Receipt of anti-cancer therapy with insufficient washout prior to Cycle 1 Day 1: No chemotherapy, radiation therapy, or small molecule tyrosine kinase inhibitors (TKI) for the treatment of cancer within 14 days or 5 half-lives (whichever is shorter) of Cycle 1 Day 1. Certain standard of care hormonal anticancer therapies, such as agents targeted to GnRH for the treatment of prostate cancer or aromatase inhibitors for the treatment of breast cancer, may be permitted after consultation with the medical monitor. No immune therapy or other biologic therapy (other monoclonal antibodies or antibody-drug conjugates \[ADCs\]) for the treatment of cancer within 28 days of Cycle 1 Day 1.
Subject is receiving systemic steroids at doses greater than the equivalent of prednisone 10 mg daily, with the exception of intermittent use for the treatment of emesis
Subject is participating in any other therapeutic clinical study (observational or registry trials are allowed)
Female subjects who are pregnant or breast-feeding
Presence of any other medical, psychological, familial, sociological, or geographic condition potentially hampering compliance with the study protocol or would interfere with the study endpoints or the subject's ability to participate in the study in the judgement of the investigator

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Honor HealthScottsdale, Arizona
Sylvester Comprehensive Cancer Center / University of Miami Miller School of MedicineMiami, Florida
Columbia University Medical CenterNew York, New York
South Texas Accelerated Research Therapeutics (START)San Antonio, Texas
Virginia Cancer SpecialistsFairfax, Virginia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 25, 2022. Always confirm current availability with the study team.

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